NCT03644316

BandGrip® Closure of Surgical Incisions Following Arthroscopic Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: BandGrip · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A single-arm, prospective, unblinded, post marketing, single center study using BandGrip to close incisions post arthroscopic shoulder surgery.

Detailed description

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.

Conditions

• Surgical Incision

Interventions

Type	Name	Description
DEVICE	BandGrip skin closure device	topical skin closure device

Timeline

• Start date: 2018-06-26
• Primary completion: 2018-08-30
• Completion: 2018-10-30
• First posted: 2018-08-23
• Last updated: 2019-07-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study