Back to resultsBandGrip® Closure of Surgical Incisions Following Arthroscopic Surgery
Primary Purpose
Surgical Incision
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BandGrip skin closure device
Sponsored by
About this trial
This is an interventional treatment trial for Surgical Incision
Eligibility Criteria
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.
Sites / Locations
- Mercy Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BandGrip
Arm Description
Topical skin closure device
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Incidence of partial wound apposition
at least 50% wound apposition
Incision Cosmesis
use of a 0 to 100 mm visual analog scale (100mm is best outcome)
Subject Satisfaction with cosmetic appearance of healed incision
use of a 0 to 100mm visual analog scale (100mm is best outcome)
Physician Satisfaction with cosmetic appearance of healed incision
use of a 0 to 100mm visual analog scale (100mm is best outcome)
Time to closure and removal of wound closure device
amount of time to apply and remove BandGrip
Adverse events
collection of device complaints
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03644316
Brief Title
BandGrip® Closure of Surgical Incisions Following Arthroscopic Surgery
Official Title
BandGrip® Closure of Surgical Incisions Following Arthroscopic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
June 26, 2018 (Actual)
Primary Completion Date
August 30, 2018 (Actual)
Study Completion Date
October 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BandGrip
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Incision
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BandGrip
Arm Type
Experimental
Arm Description
Topical skin closure device
Intervention Type
Device
Intervention Name(s)
BandGrip skin closure device
Intervention Description
topical skin closure device
Primary Outcome Measure Information:
Title
Incidence of complete would closure
Description
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.
Time Frame
30 days post treatment
Secondary Outcome Measure Information:
Title
Incidence of partial wound apposition
Description
at least 50% wound apposition
Time Frame
10 and 30 days post closure
Title
Incision Cosmesis
Description
use of a 0 to 100 mm visual analog scale (100mm is best outcome)
Time Frame
10 and 30 days post closure
Title
Subject Satisfaction with cosmetic appearance of healed incision
Description
use of a 0 to 100mm visual analog scale (100mm is best outcome)
Time Frame
10 and 30 days post surgery
Title
Physician Satisfaction with cosmetic appearance of healed incision
Description
use of a 0 to 100mm visual analog scale (100mm is best outcome)
Time Frame
10 and 30 days post surgery
Title
Time to closure and removal of wound closure device
Description
amount of time to apply and remove BandGrip
Time Frame
at surgical procedure and 10 days
Title
Adverse events
Description
collection of device complaints
Time Frame
30 days post surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyle Galles, MD
Organizational Affiliation
Mercy Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mercy Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
BandGrip® Closure of Surgical Incisions Following Arthroscopic Surgery
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