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

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

Study Overview

• Status: Unknown
• Conditions: Laceration of Skin
• Intervention / Treatment: Device: BandGrip; Device: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92868
      • Recruiting
      • University of Irvine
      • Contact: John Fox, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BandGrip; Topical skin closure device	Device: BandGrip; Topical skin closure device
Active Comparator: Standard Suture; Standard sutures will be used for wound closure	Device: Suture; Wound closure

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: BandGrip
• Investigators: Study Director: Dennis Donohoe, BandGrip

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2018
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): February 1, 2020

Study Registration Dates

• First Submitted: July 18, 2018
• First Submitted That Met QC Criteria: August 9, 2018
• First Posted (Actual): August 14, 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; Lacerations
• Other Study ID Numbers: Protocol: ERM-001, Version 01

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