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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-10-31

Brief Summary

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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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Detailed Description

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Conditions

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Port-A-Cath Placement Octylcyanoacrylate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Suture

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

Group Type ACTIVE_COMPARATOR

Suture

Intervention Type PROCEDURE

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

Octylcyanoacrylate

Skin incision closure with topic skin adhesive Octylcyanoacrylate

Group Type EXPERIMENTAL

Octylcyanoacrylate

Intervention Type DEVICE

Skin incision closure with topic skin adhesive Octylcyanoacrylate

Interventions

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Octylcyanoacrylate

Skin incision closure with topic skin adhesive Octylcyanoacrylate

Intervention Type DEVICE

Suture

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

Intervention Type PROCEDURE

Other Intervention Names

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Octyl 2-cyanoacrylate 2-octylcyanoacrylate

Eligibility Criteria

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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