BandGrip® Closure of Surgical Incisions Following Arthroscopic Surgery
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|ClinicalTrials.gov Identifier: NCT03644316|
Recruitment Status : Completed
First Posted : August 23, 2018
Last Update Posted : July 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Surgical Incision||Device: BandGrip skin closure device||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||BandGrip® Closure of Surgical Incisions Following Arthroscopic Surgery|
|Actual Study Start Date :||June 26, 2018|
|Actual Primary Completion Date :||August 30, 2018|
|Actual Study Completion Date :||October 30, 2018|
Topical skin closure device
Device: BandGrip skin closure device
topical skin closure device
- Incidence of complete would closure [ Time Frame: 30 days post treatment ]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.
- Incidence of partial wound apposition [ Time Frame: 10 and 30 days post closure ]at least 50% wound apposition
- Incision Cosmesis [ Time Frame: 10 and 30 days post closure ]use of a 0 to 100 mm visual analog scale (100mm is best outcome)
- Subject Satisfaction with cosmetic appearance of healed incision [ Time Frame: 10 and 30 days post surgery ]use of a 0 to 100mm visual analog scale (100mm is best outcome)
- Physician Satisfaction with cosmetic appearance of healed incision [ Time Frame: 10 and 30 days post surgery ]use of a 0 to 100mm visual analog scale (100mm is best outcome)
- Time to closure and removal of wound closure device [ Time Frame: at surgical procedure and 10 days ]amount of time to apply and remove BandGrip
- Adverse events [ Time Frame: 30 days post surgery ]collection of device complaints
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03644316
|United States, Iowa|
|Mercy Medical Center|
|Des Moines, Iowa, United States, 50314|
|Principal Investigator:||Kyle Galles, MD||Mercy Medical Center|