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

Status unconfirmed · Not applicable

Conditions studied: Laceration of Skin

In brief

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

Key facts

Study ID

NCT03628690

Run by

BandGrip

People needed

45

Starts

2018-07-15

Expected to finish

2020-02-01

Last updated by the study team

2019-07-10

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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.
• 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.

Where it is running

• University of Irvine — Irvine, California, United States (enrolling)

Full record on ClinicalTrials.gov

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