Comparison of Topical Skin Adhesive to Subcuticular Suture Closure of Implantable Port Incisions

Not Applicable

Completed

• Conditions: Octylcyanoacrylate; Port-A-Cath Placement
• Interventions: Procedure: Suture; Device: Octylcyanoacrylate

• Registration Number: NCT02212977
• Lead Sponsor: Duke University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-07
• Study First Submitted QC: 2014-08-07
• Study First Posted: 2014-08-11
• Study Start: 2014-09
• Primary Completion: 2015-09
• Study Completion: 2015-10
• Results First Submitted: 2016-06-20
• Status Verified: 2016-10
• Results First Submitted QC: 2016-10-14
• Last Update Submitted: 2016-10-14
• Results First Posted: 2016-10-18
• Last Update Posted: 2016-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Suture	Suture	Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture
Octylcyanoacrylate	Octylcyanoacrylate	Skin incision closure with topic skin adhesive Octylcyanoacrylate

Primary Outcome Measures

Name	Time	Method
Number of Participants With Complication of Wound Dehiscence	3 months	To compare complication rates, including wound dehiscence and infection rates between implantable port incisions closed with topical skin adhesive versus absorbable subcuticular sutures.
Number of Participants With Complication of Infection	3 months	To compare complication rates, including wound dehiscence and infection rates between implantable port incisions closed with topical skin adhesive versus absorbable subcuticular sutures.

Secondary Outcome Measures

Name	Time	Method
Healing-incision Cosmesis Score by Visual Analogue Scale	3 months	To compare resultant cosmesis with topic skin adhesive closure versus suture closure. Scale is 1-10 with 1 as the best possible outcome and 10 is the worst possible outcome.
Closure Time	Baseline	To compare closure time and associated costs between these two methods of skin closure.
Closure Materials Cost	Baseline	Per unit cost for suture and octylcyanoacrylate

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States