Phase 4
N=34
Octylseal Surgical Adhesive in General Surgery
Wounds
Bottom Line
View on ClinicalTrials.gov: NCT01514383 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: Wound Length Closure — 28.97; 21.00 milimeters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Cyanoacrylate (Octylseal ) (Device)
- Age
- Pediatric, Adult, Older Adult · 8+ yrs
- Sex
- All
- Sponsor
- Medline Industries
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Wound Length Closure |
28.97; 21.00 | — |
| SECONDARY Number of Participants With a Score of "0" (No Hurt) on the Pain Rating Scale |
34 | — |
Summary
The purpose of this study is to evaluate how surgical adhesive is used.
Eligibility Criteria
Inclusion Criteria
- Candidate for use of a topical surgical skin adhesive
Exclusion Criteria
- Subjects with know sensitivity to topical surgical tissue adhesive products or degrading products (cyanoacrylates or formaldehyde)
- Subjects with a history of keloid formation, hypotension, insulin dependent diabetes mellitus, blood/clotting disorders, peripheral vascular diseases or hypertrophy history
- Subjects who present with a contraindications for product usage as per labeling
- 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 bodily fluids or with dense natural hair
- Subjects with known hypersensitivity to cyanoacrylate or formaldehyde
Data sourced from ClinicalTrials.gov (NCT01514383). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.