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

Inclusion Criteria:

• Male/Female age 18-65.

• Subject presents to emergency room with at least one skin laceration that is assessedas 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 investigatorand refrain from picking at the treatment device, applying topical medications to thewound, 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 forparticipation 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 areaof 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.