BandGrip® Closure of Surgical Incisions Following Arthroscopic Surgery

NCT03644316 | Completed FDA Device

• 1 other identifier: OPS-002
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Surgical Incision

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Incidence of partial wound apposition

  10 and 30 days post closure

• Incision Cosmesis

  10 and 30 days post closure

• Subject Satisfaction with cosmetic appearance of healed incision

  10 and 30 days post surgery

• Physician Satisfaction with cosmetic appearance of healed incision

  10 and 30 days post surgery

• Time to closure and removal of wound closure device

  at surgical procedure and 10 days

Study Arms (1)

BandGrip

EXPERIMENTAL

Topical skin closure device

Device: BandGrip skin closure device

Interventions

BandGrip skin closure device DEVICE

topical skin closure device

BandGrip

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• BandGrip: lead

Study Sites (1)

Mercy Medical Center

Des Moines, Iowa, 50314, United States

Location

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Kyle Galles, MD

  Mercy Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: August 23, 2018
• Study Start: June 26, 2018
• Primary Completion: August 30, 2018
• Study Completion: October 30, 2018
• Last Updated: July 10, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)