Laceration of Skin
Conditions
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.
Interventions
DEVICEBandGrip
Topical skin closure device
DEVICESuture
Wound closure
Sponsors
BandGrip
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
2:1 randomization
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete wound closure | 30 days post treatment | defined as continuous approximation of skin margins without need for reintervention . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain/discomfort | index procedure and 10 days post closure | The subject will complete a 100mm visual analog scale with 100 representing worst pain level. |
| Infection | 10 and 30 days post closure | incidence of clinical infection requiring antibiotic treatment. |
| Subject satisfaction | 30 days post closure | subjects will complete a 100mm VAS (with 100 representing complete satisfaction) to evaluate their overall assessment of their scar, |
| Wound comesis | 10 and 30 days post closure | a 100mm visual analog scale (with 100 representing complete satisfaction with comesis) assessing wound cosmesis using the Comesis Visual Analog Scale. |
| Time to wound closure and device removal | index procedure and 10 days post wound closure | Time to closure and removal of closure device |
| Subject Satisfaction | 30 days post closure | indication of subject preference for method of sound closure |
| Wound Evaluation | 10 and 30 days post wound closure | assessment of the quality of wound healing by the physician. |
| Physician satisfaction | index procedure | a 100mm VAS ( with 100mm representing complete satisfaction) to evaluate the overall ease of wound closure. |
Countries
United States
Contacts
Primary ContactDennis J Donohoe, MD
Outcome results
None listed