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Clinical Trials/NCT02212977
NCT02212977
Completed
Not Applicable

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

Duke University1 site in 1 country109 target enrollmentSeptember 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Port-A-Cath Placement
Sponsor
Duke University
Enrollment
109
Locations
1
Primary Endpoint
Number of Participants With Complication of Wound Dehiscence
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2014
End Date
October 2015
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Number of Participants With Complication of Wound Dehiscence

Time Frame: 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

Time Frame: 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 Outcomes

  • Healing-incision Cosmesis Score by Visual Analogue Scale(3 months)
  • Closure Time(Baseline)
  • Closure Materials Cost(Baseline)

Study Sites (1)

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