Back to resultsA Post-Market Study of BandGrip in Traumatic Wound Closure Compared to Suture
Primary Purpose
Laceration of Skin
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BandGrip
Suture
Sponsored by
About this trial
This is an interventional treatment trial for Laceration of Skin
Eligibility Criteria
Inclusion Criteria:
- Male/Female age 18-65.
- Subject presents to emergency room with at least one skin laceration that is assessed as requiring a suture closure on the trunk or extremities (excluding hands and feet).
- The length of the laceration is less than or equal to 1.5 inches.
- Subject is otherwise in good general health in the opinion of the investigator.
- 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 BandGrip or the sutures are removed.
- Subject agrees to return for follow-up evaluations.
- Subject (or guardian) is able to comprehend and give informed consent for participation in this study.
Exclusion Criteria:
- Significant multiple trauma (merely multiple wounds are allowed).
- The wound involves a lower limb with critical limb ischemia.
- Concurrent acute infection requiring intravenous or oral antibiotics.
- Bleeding, coagulation and or clotting disorders.
- Subject is on dialysis.
- Inflammatory and or allergic diseases or conditions of the skin: for example, psoriasis, eczema or dermatitis.
- History of drug abuse.
- Chronic use of oral steroids or immunosuppressants.
- Known personal or family history of keloid or hypertrophic scarring.
- History of abnormal wound healing.
- Burst stellate lacerations due to a crush or hard blow.
- Animal or human bite or scratch.
- Wound is in the head, hands or feet or in a high skin tension area or across an area of increased skin tension on a joint.
- Investigator objects to a patient's involvement in the study protocol.
- Known allergy to components to BandGrip or suture material.
- Known cognitive or psychiatric disorder.
- Wound requiring debridement of devitalized or contaminated tissue.
- Wound at site of active rash/skin lesion making evaluation difficult.
- Previously treated wound or has failed to heal.
- Puncture wound.
Sites / Locations
- University of IrvineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
BandGrip
Standard Suture
Arm Description
Topical skin closure device
Standard sutures will be used for wound closure
Outcomes
Primary Outcome Measures
Complete wound closure
defined as continuous approximation of skin margins without need for reintervention .
Secondary Outcome Measures
Wound comesis
a 100mm visual analog scale (with 100 representing complete satisfaction with comesis) assessing wound cosmesis using the Comesis Visual Analog Scale.
Pain/discomfort
The subject will complete a 100mm visual analog scale with 100 representing worst pain level.
Infection
incidence of clinical infection requiring antibiotic treatment.
Subject satisfaction
subjects will complete a 100mm VAS (with 100 representing complete satisfaction) to evaluate their overall assessment of their scar,
Physician satisfaction
a 100mm VAS ( with 100mm representing complete satisfaction) to evaluate the overall ease of wound closure.
Time to wound closure and device removal
Time to closure and removal of closure device
Subject Satisfaction
indication of subject preference for method of sound closure
Wound Evaluation
assessment of the quality of wound healing by the physician.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03628690
Brief Title
A Post-Market Study of BandGrip in Traumatic Wound Closure Compared to Suture
Official Title
A Post-Market Study of BandGrip in Traumatic Wound Closure Compared to Suture
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 15, 2018 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
February 2020 (Anticipated)
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
an unbalanced (2:1) randomized study comparing two methods of traumatic skin closure in an ER setting: BandGrip vs suture
Detailed Description
Up to 45 subjects at up to 2 study sites who present to the ER for treatment of a skin laceration will be consented and randomized to treatment with suture or BandGrip. Subjects will be followed for 30 days post treatment to assess cosmetic quality of wound healing, evidence of adverse events related to closure method, and speed and completeness of wound closure and removal of closure devices.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laceration of Skin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2:1 randomization
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BandGrip
Arm Type
Experimental
Arm Description
Topical skin closure device
Arm Title
Standard Suture
Arm Type
Active Comparator
Arm Description
Standard sutures will be used for wound closure
Intervention Type
Device
Intervention Name(s)
BandGrip
Intervention Description
Topical skin closure device
Intervention Type
Device
Intervention Name(s)
Suture
Intervention Description
Wound closure
Primary Outcome Measure Information:
Title
Complete wound closure
Description
defined as continuous approximation of skin margins without need for reintervention .
Time Frame
30 days post treatment
Secondary Outcome Measure Information:
Title
Wound comesis
Description
a 100mm visual analog scale (with 100 representing complete satisfaction with comesis) assessing wound cosmesis using the Comesis Visual Analog Scale.
Time Frame
10 and 30 days post closure
Title
Pain/discomfort
Description
The subject will complete a 100mm visual analog scale with 100 representing worst pain level.
Time Frame
index procedure and 10 days post closure
Title
Infection
Description
incidence of clinical infection requiring antibiotic treatment.
Time Frame
10 and 30 days post closure
Title
Subject satisfaction
Description
subjects will complete a 100mm VAS (with 100 representing complete satisfaction) to evaluate their overall assessment of their scar,
Time Frame
30 days post closure
Title
Physician satisfaction
Description
a 100mm VAS ( with 100mm representing complete satisfaction) to evaluate the overall ease of wound closure.
Time Frame
index procedure
Title
Time to wound closure and device removal
Description
Time to closure and removal of closure device
Time Frame
index procedure and 10 days post wound closure
Title
Subject Satisfaction
Description
indication of subject preference for method of sound closure
Time Frame
30 days post closure
Title
Wound Evaluation
Description
assessment of the quality of wound healing by the physician.
Time Frame
10 and 30 days post wound closure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male/Female age 18-65.
Subject presents to emergency room with at least one skin laceration that is assessed as requiring a suture closure on the trunk or extremities (excluding hands and feet).
The length of the laceration is less than or equal to 1.5 inches.
Subject is otherwise in good general health in the opinion of the investigator.
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 BandGrip or the sutures are removed.
Subject agrees to return for follow-up evaluations.
Subject (or guardian) is able to comprehend and give informed consent for participation in this study.
Exclusion Criteria:
Significant multiple trauma (merely multiple wounds are allowed).
The wound involves a lower limb with critical limb ischemia.
Concurrent acute infection requiring intravenous or oral antibiotics.
Bleeding, coagulation and or clotting disorders.
Subject is on dialysis.
Inflammatory and or allergic diseases or conditions of the skin: for example, psoriasis, eczema or dermatitis.
History of drug abuse.
Chronic use of oral steroids or immunosuppressants.
Known personal or family history of keloid or hypertrophic scarring.
History of abnormal wound healing.
Burst stellate lacerations due to a crush or hard blow.
Animal or human bite or scratch.
Wound is in the head, hands or feet or in a high skin tension area or across an area of increased skin tension on a joint.
Investigator objects to a patient's involvement in the study protocol.
Known allergy to components to BandGrip or suture material.
Known cognitive or psychiatric disorder.
Wound requiring debridement of devitalized or contaminated tissue.
Wound at site of active rash/skin lesion making evaluation difficult.
Previously treated wound or has failed to heal.
Puncture wound.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dennis J Donohoe, MD
Phone
215-499-4458
Email
ddonohoeconsult@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis Donohoe
Organizational Affiliation
BandGrip
Official's Role
Study Director
Facility Information:
Facility Name
University of Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Fox, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Post-Market Study of BandGrip in Traumatic Wound Closure Compared to Suture
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