BandGrip® Closure of Surgical Incisions Following Arthroscopic Surgery

Surgical Incision Clinical Trial

Official title:

BandGrip® Closure of Surgical Incisions Following Arthroscopic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03644316
• Other study ID #: OPS-002
• Status: Completed
• Phase: N/A
• Start date: June 26, 2018
• Est. completion date: October 30, 2018

Study information

• Verified date: July 2019
• Source: BandGrip
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 30, 2018
• Est. primary completion date: August 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 1. Subject is = 18 years of age. 2. Subject had an arthroscopic shoulder procedure and has at least two skin incisions that are assessed as requiring temporary approximation of the skin edges.

3. The length of the subject's surgical incisions is less than or equal to 1.5 inches.

4. Subject must be willing to follow instructions for wound care provided by investigator and refrain from picking at the treatment device, applying topical medications to the wound, and swimming or soaking in a tub until the wound closure device is removed.

5. Subject agrees to return for all required follow-up evaluations. 6. Subject is able to comprehend and give informed consent for participation in this study.

Exclusion Criteria:

• 1. Subject has a recent history of bleeding, coagulation, and/or clotting disorders.

2. Subject is on dialysis. 3. Subject has a history of inflammatory and/or allergic diseases or conditions of the skin involving the location of the incisions (e.g., psoriasis, Eczema, or dermatitis).

4. Subject has a history of drug abuse. 5. Subject has a history of chronic use of oral steroids or immunosuppressants. 6. Subject has known personal or family history of keloid or hypertrophic scarring.

7. Subject has a history of abnormal wound healing. 8. Subject's incisions are in a high skin tension area. 9. Subject has a known allergy to BandGrip material (polycarbonate). 10. Subject has a known cognitive or psychiatric disorder. 11. Subject has an incision at site of active rash/skin lesion making evaluation difficult.

Related Conditions & MeSH terms

• Surgical Incision
• Surgical Wound

Intervention

Device:
• BandGrip skin closure device
topical skin closure device

Locations

Country	Name	City	State
United States	Mercy Medical Center	Des Moines	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
BandGrip

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 days post treatment
Secondary	Incidence of partial wound apposition	at least 50% wound apposition	10 and 30 days post closure
Secondary	Incision Cosmesis	use of a 0 to 100 mm visual analog scale (100mm is best outcome)	10 and 30 days post closure
Secondary	Subject Satisfaction with cosmetic appearance of healed incision	use of a 0 to 100mm visual analog scale (100mm is best outcome)	10 and 30 days post surgery
Secondary	Physician Satisfaction with cosmetic appearance of healed incision	use of a 0 to 100mm visual analog scale (100mm is best outcome)	10 and 30 days post surgery
Secondary	Time to closure and removal of wound closure device	amount of time to apply and remove BandGrip	at surgical procedure and 10 days
Secondary	Adverse events	collection of device complaints	30 days post surgery