BandGrip® Closure of Surgical Incisions Following Arthroscopic Surgery

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

Study Overview

• Status: Completed
• Conditions: Surgical Incision
• Intervention / Treatment: Device: BandGrip skin closure device

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Des Moines, Iowa, United States, 50314
      • Mercy Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BandGrip; Topical skin closure device	Device: BandGrip skin closure device; topical skin closure device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of partial wound apposition	at least 50% wound apposition	10 and 30 days post closure
Incision Cosmesis	use of a 0 to 100 mm visual analog scale (100mm is best outcome)	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)	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)	10 and 30 days post surgery
Time to closure and removal of wound closure device	amount of time to apply and remove BandGrip	at surgical procedure and 10 days
Adverse events	collection of device complaints	30 days post surgery

Collaborators and Investigators

• Sponsor: BandGrip
• Investigators: Principal Investigator: Kyle Galles, MD, Mercy Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2018
• Primary Completion (Actual): August 30, 2018
• Study Completion (Actual): October 30, 2018

Study Registration Dates

• First Submitted: August 20, 2018
• First Submitted That Met QC Criteria: August 21, 2018
• First Posted (Actual): August 23, 2018

Study Record Updates

• Last Update Posted (Actual): July 10, 2019
• Last Update Submitted That Met QC Criteria: July 8, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: OPS-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No