Comparison of Skin Adhesive to Subcuticular Suture Wound Closure After Port Placement

Study Overview
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Brief Summary
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Port Wound Closure compares synthetic tissue adhesives with seam for cutaneous wound closure to port plant in terms of cosmetic results and time savings at comparable risk for wound infection.

Detailed Description
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Study patients who undergo a subcutaneous venous port implant procedure are randomized into control group (conventional sutures) or into interventional group (synthetic tissue adhesive). The intervention time is documented. Follow-up visit is performed 8 weeks after port implantation. It includes a photo documentation, quality of life questionnaire (EQ5D) and pain scala questionnaire (POSAS) by patient and by 3 independent observers as well as the documentation of complications.

Official Title
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Open, Randomized, Controlled Non-inferiority Trial to Compare Synthetic Tissue Adhesive and Skin Suture After Port Catheter Implantation With Reference to Cosmetic Result and Economy of Time at Equal Risk for Wound Infection

Conditions
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Wound Closure After Port Catheter Implantation

Intervention / Treatment
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* Procedure: Suture
* Device: Experimental: Histoacryl®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Medical indication for port catheter implantation because of chemotherapy or parenteral nutrition Exclusion Criteria: Children and adolescents < 18 years Thrombocytes < 50/nl PTT <50% INR >1.5 Systemic or local infection of the interventional location Known allergy to used material Known allergy to Histoacryl, Cyanoacrylate, D&C Violett or Formaldehyd General contraindication of port catheter implantation

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 | Procedure: Suture<br>* Skin incision closure with standard subcuticular technique<br>|
| Active Comparator: Experimental: Histoacryl®<br>Skin incision closure with topic skin adhesive Histoacryl® | Device: Experimental: Histoacryl®<br>* Skin incision closure with topic skin adhesive Histoacryl® Flexible (n-Butyl-2-Cyanoacrylate Monomer)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cosmetic outcome after wound healing | Wound assessment by 3 independent evaluators (surgeons) and patient himself based on photo documentation | 8 weeks | 
| Cosmetic outcome after wound healing | Patient and observer scar assessment scale (POSAS) | 8 weeks | 
| Cosmetic outcome after wound healing | Life quality questionnaire EQ5D | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection rate | Assessment of adverse events through AE documentation based on the adverse impact of surgical site infections (German: CDC Kriterien) | 8 weeks | 
| Economy of time for wound closure | Time measurement by stopwatch and exact documentation of intervention time of subcutaneous suture and skin closure time | 10 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Skin Adhesive, Suture, Port Incisions