The Absorbable Dermal Stapler: A Faster, More Cost-Effective Method For Incisional Closure As Compared To Standard Dermal Sutures
Esther H. Teo, BS1, Kevin J. Cross, MD1, Shannon L. Wong, MD1, Christine H. Rohde, MD2, Robert T. Grant, MD, FACS2, Erin M. Weeden, MD2, Jeffrey A. Ascherman, MD, FACS2.
1Weill Cornell Medical College, New York, NY, USA, 2Columbia Presbyterian Hospital, New York, NY, USA.
Standard plastics closure of surgical wounds with multiple layers of dermal sutures can be time consuming, expose operators to potential needlestick injury, increase the risk of inflammation and infection, and have variable outcome depending on each surgeon’s technique. The INSORB subcuticular stapler (Incisive Surgical) is FDA-approved for wound closure and has been shown to have superior cosmetic results in animal models. However, no randomized controlled studies have been performed in humans. The absorbable dermal stapler is hypothesized to be a faster alternative to suture closure for reduced operating room and anesthesia time, improved cost-effectiveness, and provide a safe, consistent surgical and cosmetic result across users.
This is a prospective, randomized, blinded, IRB-approved study comparing the standard and experimental intervention in the same patient. Patients undergoing bilateral mastectomies and immediate breast reconstruction with tissue expanders had one breast incision randomized to dermal closure with absorbable dermal staples. The contralateral incision was closed with dermal sutures. During the expansion period, wounds were periodically assessed by a blinded observer using the Vancouver Scar Scale (VSS), which combines scar vascularity, pigmentation, pliability, and height ratings into a total score of 0-13. At the time of implant exchange, scars from the previous surgery were excised and evaluated for histological signs of inflammation by a blinded pathologist.
The study enrolled 11 patients (22 incisions). Average length of suture-closed incisions and dermal stapler-closed incisions were 13.5 cm and 13.3 cm, respectively (p-value = 0.857). An average of 19.6 sutures or 15.6 staples were placed per incision (1.45 sutures/cm incision, 1.21 staples/cm incision, p=0.116). Each closure required a median of 2 packages of sutures or 1 stapler, which deploys 25 dermal staples per device. Mean closure time was 14.1 minutes for sutures and 3.6 minutes for dermal staples (p=<0.001). At follow-up visit 25 days post-operatively, VSS rating was 2.0 for the suture side and 3.3 for the staple side (p=0.005). The largest difference was scar height (suture=0.41, staples=0.91, p=0.012). At the time of tissue expander exchange 194 days post-operatively VSS scores trended towards equality between the two sides. Total VSS was 2.17 and 2.67 for sutures and staples, respectively (p=0.580), with no statistical difference in any sub-category. Histological examination found reduced inflammatory cell invasion for the dermal stapler-closed scar.
There was no significant difference between length of incisions and number of sutures or staples used for closure. The dermal stapler is 4 times faster than standard suture closure, reducing closure time by 10.5 minutes (p=<0.001). With a per hour operating room cost of approximately , overall savings with the device is greater than /case. VSS rating was initially 1.3 points higher for the dermal stapler, reflecting beneficial wound eversion. VSS at subsequent visits trended towards a comparable result for dermal stapler closure as compared to suture closure. Dermal stapler-closed wounds demonstrated decreased inflammation on histological examination. The absorbable dermal stapler is significantly faster than standard suture closure techniques, allowing for a more cost effective, safer closure with equivalent cosmetic result.