Assessment of a Novel Subcutaneous, Bioabsorbable Skin Closure System

P. J Hoopes, DVM, PhD, Kenneth S Danielson, MD, FACS, Charles H Rogers, PhD, Karen A Moodie, MS, DVM, Vicki J Scheidt, DVM, DAVD, Susan A Kane, CVT, Rendall R Strawbridge, BS

The Geisel School of Medicine, and Thayer School of Engineering at Dartmouth College, and Opus KSD, Inc.

Objective: The goal of this study is to assess the cosmetic, functional and tensile strength parameters of a novel, stapler-based subcutaneous bioabsorbable skin closure system, in a porcine model.

Description and Method of Use: A disposable stapler system, preloaded with uniquely shaped bioabsorbable staples, has been developed to close various length skin incisions, including laparoscopic incisions. The "SubQ It!" stapler exploits a design geometry chosen to permit excellent visibility for the surgeon to precisely control placement of the staple, especially important in closing small 7-10 mm incisions. Once the surgeon positions the two sides of the tissue in the foot of the stapler, pressing the plunger delivers a staple which has two barbed legs connected by a flexible “bridge”. The barbs engage and the bridge holds the two tissue edges together with excellent tensile strength and security. The resulting level of tissue edge apposition and eversion is designed to permit excellent first intention healing.

Preliminary Results: The SubQ It! skin closure system was assessed in seven (7) domestic swine (35-40 kg) using a published and standardized porcine skin incision wound healing model. All animal and procedural activities were approved by The Dartmouth College Institutional Animal Care and Use Committee (IACUC) and conducted in full USDA/OLAW and FDA-GLP compliance. The Dartmouth College Animal Care and Use Program and related facilities are fully accredited by the American Association for the Accreditation of Laboratory Animal Care (AAALAC). Standard cutaneous incisions, 1cm, 2cm and 7cm in length, made by a board-certified surgeon, were closed by the SubQ It! device. For comparative purposes, a single 7cm incision in the same animal was closed using a commercially available subcutaneous suture device (INSORB® Absorbable Skin Stapler, Incisive Surgical, Inc.). Healing in the 1cm and 2cm incisions (which are too short to apply the INSORB device) was assessed by histology, clinical observation, photographs, and tensile strength tests. Incisions were allowed to heal for 3, 7, 10, 20, 30, 60 or 90 days. All incisions healed without complications and with minimal scarring. Except for very slight redness at the 3 day endpoint, the incision sites were devoid of erythema, swelling, heat, inflammation and dehiscence. Full thickness tissue samples were taken at each endpoint for histological assessment by a board certified veterinary pathologist. Pathology results will be co-registered with the clinical healing scores when available. A blinded time series of photographic images were assessed by a board certified veterinary dermatologist at each time endpoint and showed excellent results for the SubQ It! device. Of particular note, it was very difficult to discern the incision site after 30 days of healing for the 1cm and 2cm incisions.

Conclusions: Excellent wound closures were obtained for the new device. Full data in preparation for final FDA/GLP submission and clearance. Clinical trial to follow.

Session: Poster Presentation

Program Number: ETP010

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