N/A
N=109
Comparison of Topical Skin Adhesive to Subcuticular Suture Closure of Implantable Port Incisions
Port-A-Cath Placement · Octylcyanoacrylate
Bottom Line
View on ClinicalTrials.gov: NCT02212977 ↗Enrolled (actual)
109
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcome: Primary: Number of Participants With Complication of Wound Dehiscence — 0; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Octylcyanoacrylate (Device); Suture (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Complication of Wound Dehiscence |
0; 0 | — |
| PRIMARY Number of Participants With Complication of Infection |
2; 1 | — |
| SECONDARY Healing-incision Cosmesis Score by Visual Analogue Scale |
4.46; 4.4 | — |
| SECONDARY Closure Time |
8.6; 1.6 | — |
| SECONDARY Closure Materials Cost |
2.54; 25.92 | — |
Summary
Hypothesis is that incision closure with octylcyanoacrylate is inferior to closure with stitches in Port a Cath patients, who, as a population, are at increased risk for complications. All adult patients who present for initial Port a Cath placement during the recruitment period will be eligible to participate in the study. Subjects will be randomized to either skin incision closure with standard stitches or closure with skin glue. Time to complete skin closure and costs of closure will be compared. Patients will be evaluated approximately one month and three months from the procedure to assess for complications of wound breakdown or infection, as well as for the appearance of the Port a Cath incision.
Eligibility Criteria
Inclusion Criteria
- All adult patients (≥18 years) who present for initial implantable port placement during the recruitment period will be eligible to participate in the study
Exclusion Criteria
- Patients who cannot provide informed consent for the procedure will be excluded from the study.
Data sourced from ClinicalTrials.gov (NCT02212977). 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.