Introduction

In the surgical setting, technique used for wound closure is critical for overall appearance and integrity of the final scar.  Standard plastic closure of surgical wounds involves placement of multiple layers of dermal sutures, which can be time consuming, utilize several packets of sutures putting the operator at increased risk of needlestick injury, increase the risk of inflammation and infection, and have a variable outcome depending on the skill of each individual surgeon.  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 INSORB stapler is hypothesized to be a faster alternative to standard closure for reduced operating room and anesthesia time, improved cost-effectiveness, and provide a safe, consistent surgical and cosmetic result across users.

Methods

This is a prospective, randomized, blinded, IRB-approved study that allows for the unique ability to compare the standard and experimental intervention in the same patient.  Patients undergoing bilateral breast reconstruction with tissue expanders, age 18 or older, were eligible for inclusion in this study.  After expander placement, one breast incision was randomly assigned to closure using the INSORB dermal stapler and the contralateral incision was closed in standard fashion with dermal sutures. A subcuticular suture layer was placed in both groups.  Intraoperative parameters documented include length of incision, number of sutures placed/staples deployed, number of suture packets/staplers used, and time for incision closure.  Wounds were objectively assessed by a blinded observer at ensuing follow-up visits using the Vancouver Scar Scale (VSS), which combines scar vascularity, pigmentation, pliability, and height ratings into a total score of 0-13.

Results

Intraoperative data was collected on 10 patients, 20 incisions.  The average length of suture-closed incisions and INSORB-closed incisions were 13.95 cm and 13.65 cm, respectively (p-value = 0.795).  An average of 20.6 sutures or 16 staples were placed per incision (1.48 sutures/cm incision, 1.21 staples/cm incision, p=0.996).  Each closure required a median of 2.5 packages of sutures or 1 stapler, which deploys 25 dermal staples per device.  This is an estimated cost of $11.95/closure using sutures and $45/closure using the INSORB.  Mean closure time was 15 minutes for sutures and 3.8 minutes for dermal staples (p=<0.001). With a per hour operating room cost of approximately $2,000 at our institution, overall savings with the device is greater than $300/case.  At follow-up visit an average of 22.1 days post-operatively, VSS rating was 2.86 for the suture side and 4.14 for the staple side (p=0.022).  The largest difference was scar height (suture=0.29, staples=1.14, p=0.045), demonstrating effective wound eversion on the INSORB side in the early post-operative period. No significant difference was found for scar vascularity, pigmentation, or pliability.  Though data collection is ongoing, in the patients who have data available from several follow-up visits, VSS scores trended towards equality between the INSORB and dermal suture sides.  This suggests settling of wound eversion as healing matured. 

Conclusion

There was no significant difference between length of incisions, number of sutures or staples used in total, and number of sutures or staples used per cm of incision.  One INSORB dermal stapler or 2.5 suture packages were used per closure, for a cost increase of $33.05/closure using the INSORB.  However, use of the dermal stapler reduced incisional closure time by 11.2 minutes/closure (47.4 seconds/cm incision) and thus afforded great savings in overall operative costs.  VSS rating was initially 1.28 points higher for the INSORB, reflecting wound eversion, a beneficial characteristic in wound closure.   The VSS at subsequent visits trended towards a comparable result for the INSORB closure as compared to standard suture closure. 

The INSORB stapler is significantly faster than standard suture closure techniques, allowing for a more cost effective, safer, and equivalent cosmetic result.  Our study offers compelling evidence towards the beneficial properties of this emerging technology for surgical wound closure.