Study to Show Equivalence of DERMABOND PROTAPE to DERMABOND HVD for Wound Closure
Condition: Lacerations
MeSH terms: Lacerations
Intervention: cyanoacrylate with pressure sensitive mesh; cyanoacrylate
Intervention description: Topical Skin Adhesive; Topical Skin Adhesive
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 216.0
Sex: All
Minimum age: 1 Year
Healthy volunteers: No
Keywords: laceration/wound closure; topical skin adhesive

Summary:

      This is a multicenter, prospective, randomized controlled study for the purpose of comparing
      DERMABOND PROTAPE to DERMABOND HVD for closure of wounds in the Emergency Department. The
      objective of this study is to demonstrate whether the incidence of wound closure for
      DERMABOND PROTAPE is equivalent to that measured for DERMABOND HVD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  at least 1 year of age

          -  in good general health in the opinion of the Investigator.

          -  have at least one traumatic wound meeting the criteria for closure as defined in
             current Dermabond product labeling.

          -  patient must be willing to follow instructions for wound care listed in device
             labeling and refrain from picking at the device, applying topical medications to the
             wound, and swimming or soaking in a tub until the sutures are removed.

          -  patient agrees to return for follow-up evaluation

          -  patient (or guardian) signs the informed consent

          -  patient is reasonably expected to survive the study

        Exclusion Criteria:

          -  significant multiple trauma (merely multiple wounds are allowed)

          -  peripheral vascular disease

          -  insulin dependent diabetes mellitus

          -  known to have a blood clotting disorder

          -  receiving antibiotic therapy for preexisting condition or infection

          -  known to be HIV-positive or otherwise immunocompromised

          -  known personal or family history of keloid formation or hypertrophy

          -  currently taking systemic steroids

          -  known allergy to cyanoacrylate, formaldehyde, tapes or adhesives

          -  participating in another current clinical study

          -  history of abnormal wound healing

          -  burst stellate lacerations due to a crush or hard blow

          -  animal or human bite or scratch

          -  decubitus ulcer

          -  puncture wound

          -  wound at mucocutaneous junction or in mucosal (but not excluding the vermillion border
             of the lip)

          -  wound on scalp covered by natural hair

          -  wound has visual evidence of active infection

          -  gangrenous wound

          -  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

          -  wound in high skin tension area or across an area of increased skin tension, such as
             knuckles, elbows, or knees, unless the joint will be immobilized during the skin
             healing period or unless skin tension has been removed by application