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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
topical skin closure device
Mercy Medical Center
Des Moines, Iowa, United States
Incidence of complete would closure
complete 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.
Time frame: 30 days post treatment
Incidence of partial wound apposition
at least 50% wound apposition
Time frame: 10 and 30 days post closure
Incision Cosmesis
use of a 0 to 100 mm visual analog scale (100mm is best outcome)
Time frame: 10 and 30 days post closure
Subject Satisfaction with cosmetic appearance of healed incision
use of a 0 to 100mm visual analog scale (100mm is best outcome)
Time frame: 10 and 30 days post surgery
Physician Satisfaction with cosmetic appearance of healed incision
use of a 0 to 100mm visual analog scale (100mm is best outcome)
Time frame: 10 and 30 days post surgery
Time to closure and removal of wound closure device
amount of time to apply and remove BandGrip
Time frame: at surgical procedure and 10 days
Adverse events
collection of device complaints
Time frame: 30 days post surgery
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