Skin Incision Adhesive in Pediatrics
Not Applicable
Completed
- Conditions
- Wounds
- Interventions
- Device: Surgiseal
- Registration Number
- NCT01514396
- Lead Sponsor
- Medline Industries
- Brief Summary
The purpose of this study is to evaluate the effectiveness of on-label use of Surgiseal™ Tissue Adhesive, a cyanoacrylate-based Surgical Topical Skin Tissue Adhesive in wound closure of the topical skin in children presenting in the Emergency Department (ED).
- Detailed Description
Subjects had SurgiSeal™ applied to their topical skin incisions in the ED. Subjects' wounds were evaluated for bleeding and closure of the incision/wound before patient discharge and 48 hours after the procedure. Further follow up wound closure evaluations were conducted via telephone interview at 5-10 days and 14 days after the ED visit.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
Inclusion Criteria
- Between the ages of 5 and 18 years of age, inclusive
- Candidate for use of a topical surgical skin adhesive
- Informed consent by a parental guardian
Exclusion Criteria
- A wound with evidence of active infection or gangrene or wounds of decubitus etiology
- Mucosal surfaces or across mucocutaneous junctions or skin that might be exposed to body fluids or dense natural hair
- Subjects with known hypersensitivity to cyanoacrylate or formaldehyde
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Surgical Glue Surgiseal Surgiseal
- Primary Outcome Measures
Name Time Method Number of Participants With Wound Closure baseline to 14 days wound closure measured baseline to 14 days
- Secondary Outcome Measures
Name Time Method Adverse Events Related to Wound Closure 14 days Adverse events reported
Trial Locations
- Locations (1)
Akron Children's Hospital Emergency Department
🇺🇸Akron, Ohio, United States