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

NCT03628690 | Unknown FDA Device

• 1 other identifier: Protocol: ERM-001, Version 01
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Laceration of Skin

Outcome Measures

Primary Outcomes (1)

• Complete wound closure

  defined as continuous approximation of skin margins without need for reintervention .

  30 days post treatment

Secondary Outcomes (8)

• Wound comesis

  10 and 30 days post closure

• Pain/discomfort

  index procedure and 10 days post closure

• Infection

  10 and 30 days post closure

• Subject satisfaction

  30 days post closure

• Physician satisfaction

  index procedure

Study Arms (2)

BandGrip

EXPERIMENTAL

Topical skin closure device

Device: BandGrip

Standard Suture

ACTIVE COMPARATOR

Standard sutures will be used for wound closure

Device: Suture

Interventions

BandGrip DEVICE

Topical skin closure device

BandGrip

Suture DEVICE

Wound closure

Standard Suture

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BandGrip: lead

Study Sites (1)

University of Irvine

Irvine, California, 92868, United States

RECRUITING

MeSH Terms

Interventions

Sutures

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Study Officials

• Dennis Donohoe

  BandGrip

  STUDY DIRECTOR

Central Study Contacts

Dennis J Donohoe, MD

CONTACT

215-499-4458; ddonohoeconsult@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 2:1 randomization

Study Record Dates

• First Submitted: July 18, 2018
• First Posted: August 14, 2018
• Study Start: July 15, 2018
• Primary Completion: December 1, 2019
• Study Completion: February 1, 2020
• Last Updated: July 10, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)