Surgical Incision Clinical Trial
Official title:
BandGrip® Closure of Surgical Incisions Following Arthroscopic Surgery
A single-arm, prospective, unblinded, post marketing, single center study using BandGrip to close incisions post arthroscopic shoulder surgery.
The study objective is to assess the ease of incision closure, the cosmetic appearance of the
wounds on follow-up, and general subject satisfaction with the appearance of the healed
incisions following use of BandGrip. Up to 25 subjects will be enrolled at a single center.
Subjects who have undergone arthroscopic surgery of the shoulder and require closure of one
or two skin puncture sites will be enrolled. Following incision closure subjects will be seen
at the time of BandGrip removal (approximately 7-14 days after closure) and at 30 days for
assessment of the incisions.
The incidence of wound closure for each treated puncture site, defined as continuous
approximation of wound margins from the time of wound closure until the day of removal of the
wound closure device without dehiscence or need for reclosure.
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