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

Study Overview
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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.

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

Conditions
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Port-A-Cath Placement, Octylcyanoacrylate

Intervention / Treatment
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* Device: Octylcyanoacrylate
* Procedure: Suture


Participation Criteria
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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 Exclusion Criteria: Patients who cannot provide informed consent for the procedure will be excluded from the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Suture<br>Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture | Procedure: Suture<br>* Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture<br>|
| Experimental: Octylcyanoacrylate<br>Skin incision closure with topic skin adhesive Octylcyanoacrylate | Device: Octylcyanoacrylate<br>* Skin incision closure with topic skin adhesive Octylcyanoacrylate<br>* Other names: 2-octylcyanoacrylate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Complication of Wound Dehiscence | 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 | 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 | 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 | To compare closure time and associated costs between these two methods of skin closure. | Baseline | 
| Closure Materials Cost | Per unit cost for suture and octylcyanoacrylate | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Port Catheter, Octyl 2-cyanoacrylate, 2-octylcyanoacrylate