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

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ClinicalTrials.gov Identifier: NCT02212977
Recruitment Status : Completed
First Posted : August 11, 2014
Results First Posted : October 18, 2016
Last Update Posted : October 18, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Port-A-Cath Placement Octylcyanoacrylate Device: Octylcyanoacrylate Procedure: Suture Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Topical Skin Adhesive to Subcuticular Suture Closure of Implantable Port Incisions
Study Start Date : September 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : October 2015

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




Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. 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.

  2. Closure Time [ Time Frame: Baseline ]
    To compare closure time and associated costs between these two methods of skin closure.

  3. Closure Materials Cost [ Time Frame: Baseline ]
    Per unit cost for suture and octylcyanoacrylate



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02212977


Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Charles Kim, MD Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02212977     History of Changes
Other Study ID Numbers: Pro00056064
First Posted: August 11, 2014    Key Record Dates
Results First Posted: October 18, 2016
Last Update Posted: October 18, 2016
Last Verified: October 2016
Keywords provided by Duke University:
Port Catheter
Octyl 2-cyanoacrylate
2-octylcyanoacrylate
Additional relevant MeSH terms:
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Surgical Wound
Wounds and Injuries