Dr. Anthony Shibley and Dr. Sara Garmel speak about INSORB, a modern skin closure solution that is both rapid and patient-centric.
welcome and thank you for attending this event is brought to you by Cooper Surgical, a leading provider of medical devices for women's health care. For 30 years, Cooper Surgical has worked with health care providers to provide highly effective clinic and practice based contraceptive, surgical and obstetrics solutions to complement our portfolio of trusted and reliable medical devices. We have also broadened our offerings, investing in the areas of reproductive genomics and in vitro fertilization. We are fully committed to helping improve the delivery of health care to women and their families. Cooper Surgical Manufacturers over 600 clinically relevant medical devices used by health care providers and offices, clinics, operating rooms, labor and delivery suites and reproductive IVF clinics worldwide. Clinicians overwhelmingly say they trust our products for their reliability, innovation and efficiency. Here are some other interesting facts you may not know about Cooper Surgical. Since our inception in 1990 our focus has always been women's health care. With more than 600 medical devices and over 3200 product numbers across a broad range of market segments, physicians know and trust our products. We ship over 1400 orders per day, of which 99.7% are shipped the same day. Our customer service department handles over 2000 inquiries per day. We employ 1750 people worldwide. We are pleased to provide this educational opportunity on behalf of Cooper Surgical. Good evening, everyone and hello, My name is Kelly McCann. I am remaining manager and will assist in running the virtual presentation this evening. I'd like to welcome you all and thank you very much for your participation. First, I'm just going to go over a couple of notes on how this presentation will run. We have a 35 minutes high limit with questions and answers to follow. Please keep in mind that all participants will be a mute for the duration of the meeting. However, you will have the ability to submit any questions to the Q and A feature during the entire presentation, which you'll see at the bottom right corner of your screen. Both Dr Shibli and Dr Carmel will participate in a 15 minute Q and a session upon conclusion of the presentation for any questions that we do not get to this evening, you will receive a response from Cooper Cooper Surgical or the speakers following the meeting. I'd now like to introduce our speakers for this evening. Our first speaker is Dr Anthony Shibley. Dr. Shibli is a practicing physician, partner, obstetrics and gynecology specialist. P. A. A. Dina, Minnesota physician, education and surgical instructor, National International Educator, Ohio State University hospitals, obstetrics and gynecology. Our second speaker this evening is Dr Sarah Caramel. Dr. Carmel is obstetrics and gynecology and maternal fetal medicine at Beaumont Hospital. Dearborn Partner, Michigan Perinatal Associates, Belmont Hospital, Dearborn Voluntary Faculty, Beaumont Hospital, Dearborn, Wayne State University and Michigan State University School of Medicine. Clinical assistant Professor Michigan State University College of Osteopathic Medicine. I'll now turn the presentation over to our speakers to begin the presentation. Doctors. You now have presented privileges. Good evening. Thank you for the introduction. I'm Dr Tony Shibley. I'm a general practice O b g Y n in the Dina from Indiana, Minnesota, which is in the Minneapolis area working with the M Health Fairview Hospital system. Just a brief disclosure. I'm a consultant for Cooper Surgical as well as Olympus America in Advanced Surgical Concepts in Dublin, Ireland. Dr. Carmel. Thank you. Dr Shebli. I'm Sarah Caramel. I'm a maternal fetal medicine specialist. I work in Dearborn, Michigan, which is outside Detroit. I'm with the Beaumont hospital system in private practice and involuntary faculty here. My only disclosure is that I'm a consultant for Cooper Surgical this evening. We're here to talk about the INS orb sub particular stapler. It's a really great wound closure device, and you can see this photo here, and I think it's important. I like to lead with this photo because you can see the arrow is pointing to the scarring. Sometimes that may or may not come across well on your computer, which is a great sign. It means it's not an obvious scar, so the ends or some particular skin stapler is really the first of its kind. Stapler was originally invented by a plastic surgeon, and I think that's important because obviously the plastic surgeon has an eye for cosmetics. But having a minimally visible scar is really good and certainly the goal of the patients. But as I recall from one of my senior partners, when I first joined the practice that I'm currently with 25 years ago, and that he was very well known for this statement, and I'm sure he got it and he was a resident or something along those those lines. And you probably have heard it, too, that patients are going to judge you by your incisions. Whereas we think the bulk of what we do in surgery is internally, that's our good work. The patients really judges by the incision, that's all they're ever going to see. They're really not going to see what we've done inside, or how easy or hard there Caesarean section or abdominal surgery was. So again, I think it's important, because again, this is all they're going to remember from us. So it's a nice cosmetic incision, and I think what that does is that really tells us something important about the device itself. How are we able to get such a cosmetic incision? And what does that mean for the overall care of the patient? Um, I think you're gonna find that what it really represents is the reason you get a great incision is because this is a very minimally invasive type of skin closure, which leaves a very small inflammatory footprint and therefore gives us what we consider a nice wound but also lowers one complications pain, etcetera. And I think you'll kind of get an appreciation for that for myself and Dr Carmel as we proceed. So what we're really talking about here and I think this slide is going to kind of demonstrate it very well, is that this is a sub cuticle er interrupted closure modality. So instead of doing per cutaneous puncture is like metal staples or doing a sub particular running stitch, which we would do with a braided or a mono filament stitch. What we really have is a smooth monofilament staple that will kind of symmetrically about the dermis from both edges of the wound together to create the closure. So this has some unique advantages in that we don't repetitive Lee puncture the skin over and over and over again, as we do with metal staples. So we're going to get some advantage like metal staples and having a rapid closure. But we're also going to have some of the additional advantages that we might get over future. And those advantages might be seen as that the future creates kind of an airtight closure. So it's a continuous closure that creates an airtight closure, which, in my opinion really traps the fluids from the surgery within the wound itself. So we're gonna get quick operating time. We're going to get a monofilament closure modality, and we're gonna get the advantage of not having those needle sticks from using the future. And I think that you'll find that we're going to have some more other advantages, such as lower wound complications, and we'll speak to that next. So this is a photo that kind of just kind of highlights what we're talking about. You can see that this incision at the time of surgery is rather wet. So the interrupted nature of this closure makes for these kind of wet, wet wounds. And so, really, for the first day, the wound is going to appear to use or leak. And what this really is is the natural losing that's occurring in the incised tissues. And so the fluids, the fat breakdown, Uh, and really the small vascular using you're going to see now, whether whereas before, with metal staples or with a sub particular future closure, all those fluids are trapped within the wound. And that may be why we are not seeing the wound complications with the ends Or is that all that fluids allowed to drain out? So this may contribute to lower wound complications. So this is that same patient at six weeks post op, so you can see it's a very nice, smooth, non inflamed wound. You can already tell that we're not going to develop a key Lloyd or a wound problem from this, and you can see just little hints that the staples are still starting to dissolve or absorb under under the skin. Dr. Carmel. My patients are from a private practice population, which is rather obviously low risk in general and in very good health, on average, your maternal fetal medicine specialists with much higher acuity and higher risk population. So what's your experience with the ends or have been like in your high risk patients? So I mean, you're right. As an MFN specialist, my patients are in a much different spectrum than yours, and I'm sure my C section rates are even higher than yours. So I'm looking for any way to decrease my complication rate, and it may be that in sort can help us with that as soon as like it does, um, one of the biggest referral basis as patients that have uncontrolled diabetes, for instance, or patients that are Oh, be some patients are transferred to us because we're for all hospital can't take care of patients with a BMI of 50 or more. So those are typical patients that are at high risk for wound complications. And I can tell you that with in store we use that with a combination negative pressure system, similar to what you describe in terms of sucking out all that extra fluid. We really haven't had any significant wound Complications. And sometimes so no readmissions, no, Um, primary closures, no wound packing. Not since we've used this. Dr Shibley, Why did you switch to in sort And what were you using prior? So before I used the ends orb some particular stapler, Um, I was using metal staples or future really? With no clear plan in mind. I mean, I pretty had being in a private practice. Um, I pretty much closed with future during the daytime, and then I closed with metal staples at night. Or if the patient was a high risk patient, they're obese or hypertensive diabetes. Then I would oftentimes use metal staples because as we all have experienced a lot of times with metal staples. If you take those staples out on day three, some of those wounds are gonna open right up. So I was originally asked to participate in the development of the absorb stapler, and I quickly began to see the advantages and the benefits of this in my patients. So all of a sudden I started to see, like Dr Carmel said, I started to see no wound packing. No hematoma is no sir aromas in my patients. My partners started to notice this as well, and then it went beyond that and that my infection control nurse in our hospital system approached me because we were having a problem in our hospital at that time with a pretty high wound, complication rate and infection rate at Caesarean section. But the infection control nurse had noticed that my data was different and that I wasn't having those women complications. And then she actually motivated me to, um, to start a study. So I enlisted my partners, and we began the business of going about, um, collecting data. And what we did was we did in a retrospective manner is pretty much retrospectively collected prospective data, if you would. We used 500 consecutive C sections that were closed with the INS orb staplers. So those were day and night. High risk, low risk, you know, diabetics, hypertensive. It didn't matter. We did 500 of them. And then, uh, the idea was to of this paper was to report on wound complications associated with that, including standard S S. I reporting for infection as well as reporting complications such as hematoma and Ciroma. And what was interesting is in this study is that the infection rate was about 1.2% overall in these 500 patients, which was much less than we were seeing before. And at the time the hospital was seeing over 5% for an infection rate as well. During that time, in 500 patients, there were no see aromas, and there was only one wound hematoma, which is which is pretty impressive given the number of patients that were that were evaluated. Dr. Carmel, you definitely have a patient population that's at risk for these problems, like moon separations, hematoma. So, Romas and other complications can you discuss specifically how you're using the ends, orb and what adaptations you might be using in those even higher risk patients. So I've been using in storm uniformly now for almost a year. Most of my C sections are transverse incisions. I've occasionally have vertical skin incisions. I've used it for both, Um, and I think the surgical technique is the same. I mean, good him a Stasis and no tension on the incision. So that's regardless of the closure technique. But like I said and Dr Shibley mentioned also, I mean the outcome is so much better. It's really been a godsend for this patient population. This, I thought, was an exciting study. Um, it was published in 2016 at a Kansas City looking at complication rates, comparing traditional metal staples to absorbable staples and structure. And these authors found a significantly decreased complication rate when looking at in sort and future versus traditional staples. That was a statistically significant difference, and maybe even a clinically significant difference between in Sorbo and futures, with no complications in the insert group and 3.6% complication rate in the future group. I thought this was an interesting study. Two. This is 2012 out of Mayo Clinic, looking at pain scores and patients that were closed with traditional staples and absolute rule staples and found that there was a decrease federal act or toward all use and the patients that were closed with absorbable futures. And the authors mentioned that this was cost savings for the hospital. And I also think it's beneficial for our patients with substance abuse issues that have problems with hyper allergies yet, and if they could benefit from this product to, I think that would be terrific in this patient population. So I have a couple images of some of the typical patients that we have. Just These are initial post op patients. This was a patient with Class one. Obesity by corn, a uterus. Had a breech presentation, underwent a section She's at risk for Key Lloyd, so I haven't seen her back yet. This is a fairly recent section, but I'm hoping it's gonna look just as good as a as the others that we've seen in key Lloyd patients. They seem to be really well with this technology. There's a patient class two obesity failed induction underwent a C section, so right here She's got to risk factors for an infection within a one complication, her body mass index and the fact that she's an unscheduled section. It's got a beautiful incision. Here's a post up day. One patient class two obesity and uncontrolled diabetes to risk factors for a room complication. Post op day one Class one. Obesity on anti coagulation for prior thrombosis. Failed induction Needing an emergency C section. That's three risk factors for one complication with a gorgeous incision. This I like because it reminds me actually what Dr Shipley started at our presentation with This is a patient who had an emergency C section for a second twin. And when I went to see her in the hospital, you know, she was transferred to us because of mind of chorionic twins with selective value gr and abnormal Doppler. So we did all this intensive surveillance on her. She had two beautiful, healthy twins. So when I saw her in the hospital post up, she asked if she could refer her friend to me. Um and so I assumed it was because she had such excellent prenatal care. But I asked if her friend had any high risk complications because we don't typically see low risk patients. And she said no. But she thought her scar look much better than her own. So, in fact, the doctor Shipley's point that this is what the patients see, they judge you by your incisions. She had no interest in my prenatal expertise at all. She just wanted a similar scar. So, Dr Shipley, can you talk about maybe some other advantages that in store may offer besides just gorgeous skin closures? You know, Sarah, it's great that you were talking about cost effective when you started to show the the images. And I really believe that this has become a very cost effective modality for us, although we haven't specifically studied that in this particular case, uh, looking purely at cost effectiveness, Um, we've seen that in our patient population, our hospital system has recognized that, um, and I think some of the reasons are are the obvious ones. Um, you know, as the slide demonstrates, number one is that we do know that it's reduced operative time, so it's a faster wound closure than if you would would suit you. And I think it's pretty well accepted now that metal staples are not the the way to go due to the inflammatory signature. And the complications are actually higher with metal staples so over featuring this is going to give us that reduced operative time. And that may definitely save some time in the O. R. And as you know, in the covid environment that we're in currently, which is why we're doing this in a webinar. But the covid environment, it means that the operating the time the patient spends in the operating room is even higher now, so reducing operating operative time is going to be really important. And this modality definitely does that. The other thing that it does is that we're getting you guys are all out there probably in the same boat that Dr Carmel and I are in. And we don't want the patients to stay in the hospital any longer than they have to, because the hospital is where the Covid patients are also, So we want our patients out of there. Um, well, we originally wanted them out of there for other infectious reasons. We know the longer patients in the hospital, the more likely they are to have a complication. So we want them out quickly. Well, there's no barrier to discharge early discharge because we don't have any staples to remove For these patients, we don't have the added cost of staple removal or staff time to remove the staples. So we think that therefore, if we add the fact that we have a lower complication rate with the rapid closure coupled with again reducing the barrier to discharge that we might be onto something. And if you look at a study from Jammeh in 2000 and 13 and I can guarantee you the cost of hospital care has only gone up since then. Readmission averaged over $7000 a day. In fact, it was about $7500 and that the average readmission lasted five days. So having a readmission is a very costly situation, and I think even even more interestingly is how H caps comes into play with this and you may. Most people probably aren't familiar with age caps, but that is essentially the institutional pay is really now tied to patient satisfaction. I just want to say I'm so comfortable with how are incisions. Look that during the Covid era, you know were attached to the hospital. Our office is part of the hospital, and patients don't want to come in at all. So instead of them coming in for their wound, check and we're having them look at their take their PICO dressing off at home, look at their incision and take a picture of it for us. So it really saves them a trip coming in, which was always an issue because they couldn't drive and they'd have to have someone take them. But especially now they're scared to death to come back to the hospital. I think that's exactly our experience as well. These wounds are such low low we've we've turned incisions into low risk wounds with this closure modality and our level of comfort, knowing that there is such a low complication rate and such a low problem rate. And, uh, with the wounds in general that we're seeing exactly the same thing that were not necessarily having to bring in these patients back into the office. So I appreciate that back to H caps. So what is H caps? H caps is the hospital consumer assessment of healthcare providers and systems, and that's one of those you know, mouthful terms that actually means something. So in 2000 and five, Medicare, Medicaid established a standardized patient satisfaction survey. Really, it was a way designs the way to compare hospitals and patient satisfaction apples to apples by having the exact same questionnaire for each hospital. So they're the goals of that really were to to gather this data for better public accountability and reporting and and really to develop incentives for hospital. So they moved beyond that into the fact that what they found as this carried on is that patient satisfaction is directly related or indirectly inversely related to the outcomes. So even though there's not one single question in the H cap survey about complications that a study in 2000 and 14 and other studies as well have shown that there is this relationship between patient satisfaction and surgical outcomes, what it really means is that healthy patients a happy patient, there are satisfied patients, and so patients with wound complications or other complications, it's hard to make them satisfied. So even without measuring blood loss or counting infections or hospital deaths, this simple patient satisfaction survey directly relates to how the patients have done in the hospital. And since that's the case, they've actually tied reimbursement to this with another program, which is the hospital value based purchasing program. So hospitals are now being incentivized based on their outcomes, which are are largely based by that by that study. So I call that like the we're all familiar with the captain obvious commercial. I call that the Captain obvious alert. You know, which is, You know, I'm happy when I do well, and that's really what we're what we're talking about here and the state was just another way that you can have a satisfied patient, which really means you have a patient with low outcomes. So here's just a patient who's coming in for a repeat cesarean section, and this is just a quick run through so you can see that there's her previous scar on the left and then on the right. There's, uh, after her C section ready for closure, and here this patient is closed and then the decision is dressed. And unless the patient significantly obese or has other comorbidities, I'm just using a tablet or addressing online. They don't necessarily need steri strips for for these patients But I'd like to circle back to this again just a little bit, that what we're having is low maintenance wounds were having very cosmetic incisions and that, really, these things are all tied together that wrap up into lower complications. And really, um, it's looking beneath the covers. What the patient sees is a nice wound, but it really represents a low risk, um, wound. It represents a low likelihood of a return visit or a complication or a problem. One of the other things I just like to point out about the INS orb in my practice, and the long experience with it is that the results are just reproducible. So these are two patients. They're actually about a month apart within the last two months. The patient on the left. This is her pre op incision after two ends orb closures for her first two Caesarean sections, and then the patient on her right is after her four previous Caesarean sections, going for now, her fifth in short closure. So you can see that we're getting a reproducible scar each and every time after multiple abdominal incisions. And I think that, you know, here's just two patients within a two month period of time that to demonstrate that So, Sarah, I think that was great that you mentioned, um, with that one patient who is at risk for Key Lloyd's as you were showing some of your case presentations there, and I found that exactly to be the case. So in this particular patient, this patient had her first C section. You can see her significant key Lloyd there, and then this is that same patient after her repeat C section after her incision was closed within, Absorb and you can see that she's gone from having a pretty ugly key. Lloyd wound to having no key Lloyd at all. And I think that again, that's a speech directly to the lack of inflammatory presence of the ends, or I agree. I mean, it makes perfect sense, and and I've heard from other physicians that it's that it's just a difference between light and day when you close within, absorb in a patient that key Lloyd's so anyone that's prone to excessive scarring, whether it's a hypertrophic scar or key Lloyd I'm using and sort of. So here's a couple's images that like to share patients immediately post up and farther down the road. So again, a patient with several risk factors for infection post op Day one compared to two weeks post up. I'm very happy with this incision again. Class one. Obesity, uncontrolled diabetes, hypertension, superimposed clams and multiple comorbidities with, I think a beautiful scar. Advanced material age, uncontrolled diabetes to prior sections. Class three. Obesity. Gorgeous scarf. Okay, I want to wrap up this portion of the webinar, and we'll get to the Q and A here in just a minute. But I wanted to show you just a closure because, uh, there's a couple of of little techniques that can make all the difference for a smooth closure. One is, I like to close the wound edge that's opposite of me or farthest away first, and then I'll work back towards myself. I like to keep the stapler kind of moving parallel to the surface. You can see that it's it's kind of parallel to the skin surface, and then the tail is more or the bottom of the handle is more flush to the abdomen. But I'll work towards the midline. I'll close about a third or a half of the incision, and then what I want to do is turn my body and close the other corner because it's a little difficult to attract yourself in the corner. So then I'll go ahead and close the corner neck. That's nearest me, and then I'll go ahead and move towards the middle and whatever is most comfortable. Sometimes I'll just go ahead and finish off this way, or I'll revert back to switching my body back again and closing from metal to this last little bit of the incision. Um, it's a smooth and easy closure. And then you can dress this wound however you want. I used to get our dressing. I don't use steri strips very often. Maybe if there's comorbidities with patients obese, um, or multiple C sections. Uh, then I'll go ahead and use some steri strips. Dr. Carmel, has that been your experience as well? Um, well, I'm working with the residents typically, so we'll each do half of an incision and meet in the middle because we like to use it. I don't use many steri strips at all, and if I have a patient with morbidity is instead of a steri strip, I'll use a negative pressure dressing. I'm using that predominantly with our patients. That's great. Let's move on to the Q and A. Thank you so much, Doctor. Civilian Doctor Caramel. I'm going to turn the Q and a portion of our program over to Humberto Contreras from Cooper Surgical, who will present the questions to the luminaries. Good evening, everybody. First questions for a doctor. Shibley. Doctor Shibley, can you use the corpse Skin stapler on vertical incisions? Uh, you can, actually, And it's a really good closure for mid lines. The, uh, one note would be in the obese patient. You want to go ahead and put a few deep, uh, dermal interrupted stay futures you want You want to take the pressure off? That way, I definitely will use Steri strips again just to reinforce, because there is a little bit more pressure on the midline. Um and I would do that if I was featuring featuring as well Dr Carmel, the next questions for you. What moon dressing do you use? A K? Any pressure dressing in particular? Typically, I'm using the PICO. I don't use a pressure dressing now. Yeah, so negative wound dressing. Dr Shibley, Any patient, uh, that you have seen where the state has been rejected, the in short staple has been rejected. Oh, I think rejected might not be the right term. The there are some miss placements that where you actually don't place the staple within the dermis and you have an epidermal penetration that usually is what you might find. These are really non inflammatory. I think we all have a lot of experience with futures that spit. You know, if you use a monocle or vicryl for a skin closure, and then the patients will spit of future and you'll have a lot of inflammation with that, these are almost uniformly, absolutely non inflammatory. So you will actually see a little white plastic staple sticking up through the incision or through the wound edge somewhere with no redness whatsoever, no inflammation, and just tell the patients to leave it alone and put a Band aid on it. Um, you know, rush it off if they need to, but you really don't even need to see those patients back. I used to bring them back in if they were complaining. Um, but it's a really rare occurrence, and now I know that they are completely non inflammatory. And I just remind, you know, now we can zoom and take a look at them or do any visit. But But really, just to reassure the patient because you are gonna have a problem with those whatsoever. Uh, Dr Shively, um, it says here I'm noticing that the incisions are raised. Is that normal? Uh, yeah, that's actually really a good thing. I mean, I think we probably all learned that as medical students that you want to have an inverted wound. So when the wounds, when the wounds averted over time, it will settle more flush. And, you know, the plastic surgeons talk a lot about incisions, especially those decisions that will kind of invert or dent in. And what it really does gathers light and create shadows and make some more prominent looking incision. So these wounds actually really do settle over time and lay down flush. So it means there's less pressure on the, um, the dermal epidermal interface there. So right on the skin edge, there's less pressure. And and that allows that healing to occur, I think, probably contributing to less car Dr Carmel. The next questions for you. Do you ever get overlapping of the skin borders when you're using the INS orb skin stapler? Mhm. Well, I think it's more common if we're doing like a repeat C section. Sometimes the edges, if we haven't taken the scar out, are sort of scarred in place. So potentially that could be the case. But I don't think it's as much overlapping. If I had to say we have an issue with repeat sections or is that sometimes they're not meeting, you know, completely opposed. You know, I think I've seen that, too. I'll weigh in a little bit on that as well. You know, sometimes I think if you if you really work at it and try to place those staples in the really deep dermis, you could have some potential for some overlap. But if you really just follow the guides and there are guides on the device, um, you really shouldn't have that happen. Okay. Question for you, Dr. Carmel. How many cases did it take you to feel comfortable using the absorb stapler? Um, I think it probably depends a little bit on the patient, but I would say somewhere between three and five that your experience to Dr Shipley? You know, I'm a hard one to ask because I was originally dealing with a prototype where we had to put one people in at a time. So I kind of learned took a lot longer than that with the original prototype. But the what I've seen from others think surgeons are. We're all surgeons and we're all highly skilled. And we pick these things up quickly, and And once you have the hang of it, after a few cases, then you'll be able to make your own little adjustments that make you feel more comfortable using it. Dr. Shelley, nice questions for you. Do you often see the stables go through the skin? And would it be wise to remove those files and redo it again? Um, I would say that you could see that for sure. If you go through a stretch mark, for instance, sometimes that's very, very skin epidermis I use. Uh, my kind of rule of thumb is if I were going to be doing a sub particular future, and I wouldn't be able to accomplish that because the epidermis is so thin and there are those patients are really rare. I would see one every couple of years. I would say then, in that patient, you're just gonna use metal staples because featuring or even using the inside, or you're just not going to be able to get those to eat because they're interested. Irma's now. That's a really rare patient, though, so in most cases, you're not going to have that happen again. If you were to have it happen, you can you can take those staples out, and the easiest way to do it is with the heavy scissor with the future scissor and just go ahead and and, uh, and cut the future. And then they will remove easily because they are barbed. And so you want to cut in the U shaped portion and then just pull from the the distal end. Dr. Carmel, The next questions for you. How would the in short staple help in patients that have a higher BMI? When you're comparing it to futures faster, you have to worry about needle sticks. Um, they feel better. Those are the patients that we tend to have our readmissions or wound packs. I mean, I think it's just especially good for patients with higher B m I. To be honest, I mean, I don't I don't mean to minimize this, but I think a skinny patient with a primary section, uh, those always feel fine. So it's really the heavier patients that need the extra help. And I think in sort is perfect for that type of patient. You know, that's been my experience as well. And in the study that we did that I talked about with the 500 consecutive patients, um, we had there were, you know, no sir aromas in that group. And I think that kind of speaks to the interrupted nature of the closure and and, uh, you know, one hematoma, notes, aromas and 500 patients. And so again, I think it's ideal for the obese patients. I totally agree. They usually have really thick girls, too. So the doctor should be. The next question is for you. Are there any patients you would not use? Indoor bond? Like I said, I think the judgment call is those, uh, extremely rare patients that are just going to have, um their epidermis is just to them, and you just aren't going to be able to step you through it and you're not gonna be able to put a staple in the dermis that's not going to penetrate the epidermis, and that's really going to be a rare patient. Otherwise, there's really no no major contraindications to it and that I can really say in my experience over 10 years or using it that I've run into. The next question is for both of you. So we'll start with Dr Carmel says. We've noticed a lot of it's multiple C section patients prior to using ends. Or, um, do you remove the scar In this case, uh, I think they would look better if you remove the scar. But typically, I don't just because of the time factor, especially if you're trying to deliver a baby quickly, Um, but I think it probably would look better if you took the time to take this car out. I haven't had any problems leaving the scar in, but in general, don't mhm. I don't think we have a prospective look at whether you remove the scar or don't remove the scar. I routinely do it again. I'm in a suburban population that wants to have a nice incision um, and were often not under the gun in terms of time and only, you know, for us it will take some extra couple of minutes to go ahead and just excise that decision. Then you're you know, then you are putting fresh edges together and and being those reproducible results, Dr Shibley, next questions for you. If you are learning and using the in store for the first time, what patients would be a good candidate to begin to use it on? And would you steer away from any If you're using it, you know, I wouldn't steer away. And I think one of the things we take for granted sometimes that we all learned and originally we learned suturing it took us a long time to figure it out. Um, but we learned on patients, and then we learned to do metal staples. And still, we fumbled through that as medical students trying to figure that we're pretty adept at learning new things. Um, and this isn't any more difficult. It's different than what we're used to, because it's a different way of doing things, But, um, it's not difficult. It's just different. So I wouldn't steer away from any particular patient. Next, questions against for both of you. Uh, we'll start with Dr Chilly this time. Have you seen your infection rates go down for using from using in sort? Yeah, absolutely. I mean, that's one of the things again. That's that's what motivated that initial study is the infection control nurse noted that we just weren't I wasn't having those infections, and, um, and then, as my partners got on board, they over them also noticed the fact that we just weren't weren't having the infections. And, you know, one of the things that we don't know. If you look back at that study that we did that at that time, that was over a four year period of time. The preoperative antibiotic use was only 85% because it wasn't a uniform, Um, recommendation at that time for some of these patients, and the antibiotics changed over time as well. So you know, to have that low of an infection rate at 1.2% with no patients excluded in 500 is pretty pretty. I was I was impressed at the time, and it's still an impressive number. I agree. Absolutely decreased no question in our patient population, no question. Yeah, again, this question is for both of you again. Have you had any different differing results between primary and repeat C sections As far as the level of a version or the final scar? I'll different there now because I'm mostly excising scars. So repeat the famous primaries. A lot of the cases for me. So I can tell you it is a little bit tougher sometimes to do with Repeat because this car is a little bit thicker. Um, and sometimes Well, I'll have. Usually it's a I mentioned that the residents and I will split the incision half and half, but, um, for someone that's got a six car, we'll do it together. So one of us will bring up the tissue edges and the other one will place the stapler if we need to. If we can approximate the skin around the stapler as well. So that's how we've adjusted. Okay. Mhm. Dr. Shipley, Next questions for you. It says you mentioned earlier you can use in Sorbonne. Vertical incisions. Is there any change in your technique when you're using it? Yeah, again. The change in technique is going to be not how I handle the stapler. I will put an Alice. I'll put an Alice on either end of the vertical. So then that way, I can, actually, because again in vertical incision, sometimes to get the edges to line up more correctly. If you put an Alice clamp on either end and then give some traction, you can, um, make sure that the that the skin edges are colonel lineups. That's one thing that I do. In that case, I do do the same thing. Make sure you close the corners first, but depending on if the patient's obese, actually, go ahead and put some interrupted, you know, three. Oh, Vicryl three monochrome Just to again take extra tension off the wound. The woman you know where the the the one that would be. And I will do that if I was featuring, um, we typically wouldn't do that if we were stapling. We just In the old days, we would leave the Staples in for seven days. So which we don't want to do the that that anymore, Dr. Carmel, are either of your patients the ones that you've had they been alarmed with by the wounded version caused by the absorb skin stapler. I think the nurses initially were, and we told them mainly to not to be nervous about the sea bitch that they would see on the dressing. I think that's what concerned them the most. Um, and sometimes in the O. R will actually take a picture of the incision for the patient and tell them that it's gonna point. They've been overwhelmingly happy with their incision with time. But if I do take a picture in the O. R to show them, since they can't see it that day, um, warn them about the aversion. And like I said, the main issue was just warning the nurses that they're going to have some drainage a little bit more than usual. That's not a problem anymore. I think they're just used to it now. Dr Shibley, this one's for you to follow up just on the aversion, it says. How long does it take for the aversion to lay down? And what is the longest that you have seen? The aversion? You know, it's uniformly gone by the six weeks when they come in for a postpartum checkup, so it'll vary from that time. But the tensile strength or the statements are going to start to lose some of their tensile strength in about at about 40% in 14 days. So they'll start to open up a little bit and flatten out in about two weeks. Uh, and then gradually they're on, and it'll be completely, completely flat, although if you would feel the wounds, you can still feel some of the staples under the skin at six weeks for most patients. But you really can't see them very much at all by that time. And then it certainly resolves over time completely. Dr. Carmel, this one's for you. If you did have a wound complication, what would be the best way to remove the in sort stapler? Um, and are you concerned about the fragments that are left behind? I'm not concerned about the fragments I have never actually want to take. Um, I haven't had a complication yet. Thankfully, I've never had actually opened an incision, but I think if I had to, I would probably just cut them with the Super Scissors or some type of scissors. I can speak to that because, you know, over time, you're gonna run into that? I had this just about three months ago. Patient who had, uh, uncomplicated, uh, c section for, uh, it was a presumed uterine anti r uterine rupture. Wasn't necessarily wasn't the case, but the patient was hemorrhaging literally before we got her off the table. And she actually did end up rupturing in her lower uterine segment posterior early, and it wasn't recognized. We didn't recognize it at her at the time of her C section, so C section was uncomplicated. We had a wound close, and then she started to drop her pressures, and we noticed that she was having significant vaginal bleeding. So in that case, you just have to take your future scissors and just go ahead and and and cut through the through the staples. It's easy to do. Uh, then you don't have to worry about the fragments. Go ahead and go ahead. In that case, use um um, metal staples because the last thing you're gonna do and that kind of emergency is try and pick out little staple fragments. It's a rare occurrence, but you're not gonna want to do that. You're just gonna want to put some staples in and you're gonna have to go in a different, different direction. And there's just the metal staples and again featuring You've had the same problem. If you're gonna shoot, you're gonna run into fragments of the ends orb because those cleats are going to hold them in place in the dermis. So don't worry about the ends or fragments and go ahead and just use metal staples. Next question is for both of you doctors. Can you talk about the importance of that initial training that you guys had with the indoor stapler, the demonstration by your Cooper surgical rep and the support afterwards, how important that is? Uh huh. Well, the only reason I want to bring this up is because we've had I mean, I think the residents are ready, impressed with the results, and so they're having some of the other attendings use it. They're talking about it. And if the offending haven't been trained by a resident or the surgical rep that they're not really liking the results and they've decided they don't want to use it, and I've heard from a couple of them, I think it's really, really important to have someone either a surgical rapper adapt comfortable using the stapler. Show the attendings how to use it. Because otherwise, they're just not gonna have a good result. They're going to decide not to use it again. At least that's what I've seen here. Yeah, I would have to agree with it. I mean, that's the difficult thing that you encounter again. It's not difficult, but it is different. And it does take a little bit of a little bit of training. Not much. But the basic thought is, Oh, it's a state where I can just pick it up and use it. And the answer is no. It is. It is different. Mhm. Dr. Shipley, this question is for you. Have you studied the ins or stapler and its practice in your abdominal hysterectomies? Okay. No, because I haven't done an abdominal hysterectomies for a very long time. I can tell you that in the rare case where we do an abdominal hysterectomy. Um, any abdominal incision? It's great for, So we definitely use that Dr. Carmel, The next question is for you at the end of your endorsed stapling. I know you talked about it Or do you steri strips or doorman to fix the closure. No, I don't use steri strips. Although I think it would be fine to use them. I think the Durban doesn't really make sense because one of the advantages of the in storm is that the fluid can progress through the opening between the staples. So I'm not sure the Durban to use, but I think the steri strips should be fine. Dr. Shibley, next questions for you. Do you have any data on the future? Half life? Um, effect of of the primary versus repeat C sections for short? Uh, no, no, I don't have any data on that again. I think, really, the data we have is again that that tensile strength in the breakdown is going to be about 40% at 14 days. So it's going to be. But I don't know if that differs again on a repeat versus a primer that hasn't really looked at what the next question is for you. Dr. Shipley again says we notice some pictures of the INS or being used for key Lloyd scars and pigmentation. What has been your experience aside from that picture? Uh, same. So my experience has been in our patients at risk for key Lloyd patients who are previous key Lloyd farmers that they are going to have much lower likelihood. You're still going to get that rare. That key Lloyd's with anything, no matter what you do to them. But the majority of them. Um, when I had a previous key, Lloyd, and then come back at those patients, uh, the door has been a much, much improved incision over their primary incision. Next question is for you, Dr Carmel, Have you seen these in sort staples spit in any way for truth through the skin? Um, occasionally, I've seen them when they come back for their post op check. Um, and if they're bothering the patient, if they're poking out, we'll take them out. Otherwise we'll just leave them. Is that is that with the authors asking Or they're asking at the time of C section, It's going to be I'm not going to be sure, but I'm going to say both at the time. Have you seen them spit? And when you come back when they come back and what has been your reaction, your external, I think they're just placed improperly but and that may be the case when they come back to, but they do come back, and if it's bothering them, for whatever reason, the patients feel it. We'll take it out if they want. Or, well, even if it's not bugging them. Dr. Shipley, do you have anything to say on that? Yeah, it's almost. It's almost always again. It's almost always going to be that there was. There was an external placement of a staple, as opposed to spitting. But you know, I have seen where, you know, probably the arm of the end zone was right under the epidermis or into a a stretch mark or something. And then what happens is maybe over time that tip has poked out. So I've seen a couple of those over the years, and again, it's not the same because they're not. It's not an inflammatory process that's extruding the staple like you see, like about traditionally spitting a future. It's a woman. I think it probably does just results from pressure and and having a very close placement, but they're going to be rare. Um, next question is for it can be free to one of you, Doctor Dr Carmel what is the strength of the indoor staple when you compare it to your futures that used to use before? I think it's similar to a lot of our docks used for closure if they're using future. I think it's very, very similar to that. In terms of the tensile strength. At least it's a similar biochemical makeup to monochrome. So it's a it's going to be a little thicker than a monochrome would be. In terms of that, I mean, it's going to be more like a A one I would have to have never actually measured to see. But it's bigger than going to be thicker than an O structure would be. But again, it's a similar chemical composition to a monocle. Very strong, very strong. They're not gonna break. I haven't seen my break. If they're if they were to somehow come apart, it's gonna pull a piece of the dermis off from one side or the other. It's not going to be because it was strong. Alrighty. So that's going to include conclude our Q and A for this evening. Thank you again, Doctor Shibli and Dr Carmel. As a reminder, Cooper Surgical will be following up with any questions that are speakers were not able to get to during this evening's program.
