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

Not Applicable

Completed

• Conditions: Wound Closure After Port Catheter Implantation
• Interventions: Procedure: Suture

• Registration Number: NCT02551510
• Lead Sponsor: Jena University Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-17
• Study First Submitted QC: 2015-09-15
• Study First Posted: 2015-09-16
• Primary Completion: 2019-03
• Study Completion: 2019-05
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-09
• Last Update Posted: 2020-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Suture	Suture	Skin incision closure with standard subcuticular technique

Primary Outcome Measures

Name	Time	Method
Cosmetic outcome after wound healing	8 weeks	Life quality questionnaire EQ5D

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Jena; 🇩🇪 Jena, Thuringia, Germany