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

Duke University

Status: Completed

Conditions: Port-A-Cath Placement; Octylcyanoacrylate

Treatments: Device: Octylcyanoacrylate; Procedure: Suture

Study type: Interventional

Funder types: Other

Identifiers

NCT02212977

Pro00056064

Details and patient eligibility

About

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.

Enrollment: 109 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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109 participants in 2 patient groups

Suture

Active Comparator group

Description:

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

Treatment:

Procedure: Suture

Octylcyanoacrylate

Experimental group

Description:

Skin incision closure with topic skin adhesive Octylcyanoacrylate

Treatment:

Device: Octylcyanoacrylate