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

October 14, 2016 updated by: Duke University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

109

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Suture
Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture
Procedure: Suture
Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture
Experimental: Octylcyanoacrylate
Skin incision closure with topic skin adhesive Octylcyanoacrylate
Device: Octylcyanoacrylate
Skin incision closure with topic skin adhesive Octylcyanoacrylate
Other Names:
  • Octyl 2-cyanoacrylate
  • 2-octylcyanoacrylate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healing-incision Cosmesis Score by Visual Analogue Scale
Time Frame: 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.
3 months
Closure Time
Time Frame: Baseline
To compare closure time and associated costs between these two methods of skin closure.
Baseline
Closure Materials Cost
Time Frame: Baseline
Per unit cost for suture and octylcyanoacrylate
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Charles Kim, MD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

August 7, 2014

First Submitted That Met QC Criteria

August 7, 2014

First Posted (Estimate)

August 11, 2014

Study Record Updates

Last Update Posted (Estimate)

October 18, 2016

Last Update Submitted That Met QC Criteria

October 14, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pro00056064

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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