Evaluation of a Subcutaneous Bioabsorbable Fastener for Closing Incisions

Kenneth S Danielson, MD, FACS, Charles H Rogers, PhD. Opus KSD, Inc.

Objective: The goal of this study is to assess patient outcomes after closing incisions in a variety of procedures with the newly approved SubQ It! bioabsorbable skin closure system.

Description and Method of Use: A disposable stapler system, preloaded with patented bioabsorbable fasteners, has the ability to deploy its fasteners into small 7-10mm incisions. Unique design elements of the stapler allow the surgeon to precisely position the tissue, especially important in closing short laparoscopic incisions. Once the surgeon positions the two sides of the incision in the foot of the stapler, pressing the plunger delivers a fastener into the underside of the dermis. The fastener has two barbed legs connected by a flexible “bridge”. The barbs engage in the dermis and the bridge holds the two edges in approximation by tension, similar to a traditional manual suture. Because the fastener is biodegradable and deployed subcutaneously, there is no need for the patient to return for staple removal.

Preliminary Results: The SubQ It! skin closure system was assessed in twenty two (22) patients in ten (10) different types of surgical procedures. Eleven (11) patients had laparoscopic procedures including Laparoscopic Ventral Herniorrhaphy, Laparoscopic Tubal Ligation, Extraperitoneal Herniorrhaphy, Laparoscopic Nissen Fundoplication and Laparoscopic Cholecystectomy.  The remaining eleven (11) patients had five (5) other types of procedures included Umbilical Herniorrhaphy, Thyroid Lobectomy, Infusion Port Placement, Breast Lumpectomy and C-Section. Wound open time for the procedures ranged from 25 to 120 minutes with an average of 61 minutes.  The SubQ It! stapler was successfully used to close all fifty-six (56) incisions in the 22 cases. Two-hundred twenty-nine (229) fasteners were deployed.

Results at Postoperative visit #1: bleeding/staining in the dressing was noted in 24% of the incisions.  The average “worst” pain that patient had experience post operatively was 4.4 (0-no pain, 10-worst).  The average pain at the visit was 1.6 (0-no pain, 10-worst).  The patient’s assessment of the appearance of the incisions averaged 1.5 (0-best, 10-worst).  The scores provided by the physician using the Hollander Wound Evaluation Scale (HWES) were 5.4 (0-worst, 6-best) or 90%. Results at Postoperative visit #2:  3% of patients reported infection at any time since surgery.  Wound separation was noted in 3%, all of which were minor.  Average pain level was 0.5 (0-no pain, 10-worst).   Appearance as judged by the patient was 0.9 (0-best, 10-worst). Physician scores of appearance using the HWES was 5.6 (0-worst, 6-best) or 93%.
 

Conclusions / Future Directions: Pain appeared acceptable as it related to the procedure performed.  Drainage and incidence of infections were comparable to other subcuticular wound closure methods.  Final overall appearance and HWES scores were excellent.  Although developed for closing short laparoscopic incisions, the SubQ It! subcuticular skin closure system has the potential to be applied in a broad range of skin closures.

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