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

NCT ID: NCT03628690

Last Updated: 2019-07-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-15
• Study Completion Date: 2020-02-29

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.

Conditions

Laceration of Skin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BandGrip

Topical skin closure device

Group Type: EXPERIMENTAL

BandGrip

Intervention Type: DEVICE

Topical skin closure device

Standard Suture

Standard sutures will be used for wound closure

Group Type: ACTIVE_COMPARATOR

Suture

Intervention Type: DEVICE

Wound closure

Interventions

BandGrip

Topical skin closure device

Intervention Type: DEVICE

Suture

Wound closure

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BandGrip

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dennis Donohoe

Role: STUDY_DIRECTOR

BandGrip

Locations

University of Irvine

Irvine, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Dennis J Donohoe, MD

Role: CONTACT

ddonohoeconsult@gmail.com

215-499-4458

Facility Contacts

John Fox, MD

Role: primary

Other Identifiers

Protocol: ERM-001, Version 01

Identifier Type: -

Identifier Source: org_study_id