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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Mercy Medical Center
Des Moines, Iowa, United States
Start Date
June 26, 2018
Primary Completion Date
August 30, 2018
Completion Date
October 30, 2018
Last Updated
July 10, 2019
25
ACTUAL participants
BandGrip skin closure device
DEVICE
Lead Sponsor
BandGrip
NCT03561376
NCT07173621
Data Source & Attribution
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