Recruiting

BandGrip vs. Suture

Sponsor:

BandGrip

Code:

NCT03628690

Conditions

Laceration of Skin

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

BandGrip

Suture

Study Details

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

Study ID

NCT03628690

Start date

Jul 15, 2018

Status verified date

Jul, 2019

Completion date

Feb, 2020

Anticipated

Primary completion date

Dec, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BandGrip

Topical skin closure device

active comparator: Standard Suture

Standard sutures will be used for wound closure

Interventions

BandGrip

Topical skin closure device

Suture

Wound closure

Primary outcome measure

  • Complete wound closure [ Time Frame: 30 days post treatment ]

Central Contacts and Locations

Central contacts

Dennis J Donohoe, MD

215-499-4458ddonohoeconsult@gmail.com

Locations

University of Irvine

Recruiting

Irvine, California, United States, 92868

More Information

Sponsor

BandGrip

Last update posted

Jul 10, 2019

Last verified

Jul, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by BandGrip on 2019-07-10.