A Post-Market Study of BandGrip in Traumatic Wound Closure Compared to Suture

Study Overview
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Brief Summary
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an unbalanced (2:1) randomized study comparing two methods of traumatic skin closure in an ER setting: BandGrip vs suture

Detailed Description
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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.

Official Title
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A Post-Market Study of BandGrip in Traumatic Wound Closure Compared to Suture

Conditions
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Laceration of Skin

Intervention / Treatment
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* Device: BandGrip
* Device: Suture


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2:1 randomization
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BandGrip<br>Topical skin closure device | Device: BandGrip<br>* Topical skin closure device<br>|
| Active Comparator: Standard Suture<br>Standard sutures will be used for wound closure | Device: Suture<br>* Wound closure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete wound closure | defined as continuous approximation of skin margins without need for reintervention . | 30 days post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound comesis | a 100mm visual analog scale (with 100 representing complete satisfaction with comesis) assessing wound cosmesis using the Comesis Visual Analog Scale. | 10 and 30 days post closure | 
| Pain/discomfort | The subject will complete a 100mm visual analog scale with 100 representing worst pain level. | index procedure and 10 days post closure | 
| Infection | incidence of clinical infection requiring antibiotic treatment. | 10 and 30 days post closure | 
| Subject satisfaction | subjects will complete a 100mm VAS (with 100 representing complete satisfaction) to evaluate their overall assessment of their scar, | 30 days post closure | 
| Physician satisfaction | a 100mm VAS ( with 100mm representing complete satisfaction) to evaluate the overall ease of wound closure. | index procedure | 
| Time to wound closure and device removal | Time to closure and removal of closure device | index procedure and 10 days post wound closure | 
| Subject Satisfaction | indication of subject preference for method of sound closure | 30 days post closure | 
| Wound Evaluation | assessment of the quality of wound healing by the physician. | 10 and 30 days post wound closure |