Clinical trial NCT03628690: A Post-Market Study of BandGrip in Traumatic Wound Closure Compared to Suture
Official title: A Post-Market Study of BandGrip in Traumatic Wound Closure Compared to Suture
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laceration of Skin
Lead sponsor: BandGrip
Sponsor class: INDUSTRY
First posted: 2018-08-14
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2:1 randomization
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Complete wound closure
timeFrame: 30 days post treatment
Secondary outcomes:
measure: Wound comesis
timeFrame: 10 and 30 days post closure
measure: Pain/discomfort
timeFrame: index procedure and 10 days post closure
measure: Infection
timeFrame: 10 and 30 days post closure
measure: Subject satisfaction
timeFrame: 30 days post closure
measure: Physician satisfaction
timeFrame: index procedure
measure: Time to wound closure and device removal
timeFrame: index procedure and 10 days post wound closure
measure: Subject Satisfaction
timeFrame: 30 days post closure
measure: Wound Evaluation
timeFrame: 10 and 30 days post wound closure
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of Irvine
state: California
Study officials:
affiliation: BandGrip
name: Dennis Donohoe
role: STUDY_DIRECTOR
References: