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OpenTrials
Completed

NCT Number: NCT02212977

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

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.

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Key information

Conditions

Port-A-Cath Placement Octylcyanoacrylate

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Octylcyanoacrylate

Device

Skin incision closure with topic skin adhesive Octylcyanoacrylate

Other names: Octyl 2-cyanoacrylate, 2-octylcyanoacrylate

Suture

Procedure

Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 11, 2014
Registry last updated
Oct 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.