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

Jena University Hospital

Status: Completed

Conditions: Wound Closure After Port Catheter Implantation

Treatments: Procedure: Suture; Device: Experimental: Histoacryl®

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02551510

4164-07/14

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 128 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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128 participants in 2 patient groups

Suture

Active Comparator group

Description:

Skin incision closure with standard subcuticular technique

Treatment:

Procedure: Suture

Experimental: Histoacryl®

Active Comparator group

Description:

Skin incision closure with topic skin adhesive Histoacryl®

Treatment:

Device: Experimental: Histoacryl®