an unbalanced (2:1) randomized study comparing two methods of traumatic skin closure in an ER setting: BandGrip vs suture
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
University of Irvine
Irvine, California, United States
RECRUITINGComplete wound closure
defined as continuous approximation of skin margins without need for reintervention .
Time frame: 30 days post treatment
Wound comesis
a 100mm visual analog scale (with 100 representing complete satisfaction with comesis) assessing wound cosmesis using the Comesis Visual Analog Scale.
Time frame: 10 and 30 days post closure
Pain/discomfort
The subject will complete a 100mm visual analog scale with 100 representing worst pain level.
Time frame: index procedure and 10 days post closure
Infection
incidence of clinical infection requiring antibiotic treatment.
Time frame: 10 and 30 days post closure
Subject satisfaction
subjects will complete a 100mm VAS (with 100 representing complete satisfaction) to evaluate their overall assessment of their scar,
Time frame: 30 days post closure
Physician satisfaction
a 100mm VAS ( with 100mm representing complete satisfaction) to evaluate the overall ease of wound closure.
Time frame: index procedure
Time to wound closure and device removal
Time to closure and removal of closure device
Time frame: index procedure and 10 days post wound closure
Subject Satisfaction
indication of subject preference for method of sound closure
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Time frame: 30 days post closure
Wound Evaluation
assessment of the quality of wound healing by the physician.
Time frame: 10 and 30 days post wound closure