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

Wound Closure After Port Catheter Implantation Clinical Trial

— PWC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02551510
• Other study ID #: 4164-07/14
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: May 2019

Study information

• Verified date: March 2020
• Source: Jena University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: May 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Wound Closure After Port Catheter Implantation
• Wounds and Injuries

Intervention

Procedure:
• Suture
Skin incision closure with standard subcuticular technique

Device:
• Experimental: Histoacryl®
Skin incision closure with topic skin adhesive Histoacryl® Flexible (n-Butyl-2-Cyanoacrylate Monomer)

Locations

Country	Name	City	State
Germany	University Hospital Jena	Jena	Thuringia

Sponsors (2)

Lead Sponsor	Collaborator
Jena University Hospital	Aesculap AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cosmetic outcome after wound healing	Wound assessment by 3 independent evaluators (surgeons) and patient himself based on photo documentation	8 weeks
Primary	Cosmetic outcome after wound healing	Patient and observer scar assessment scale (POSAS)	8 weeks
Primary	Cosmetic outcome after wound healing	Life quality questionnaire EQ5D	8 weeks
Secondary	Infection rate	Assessment of adverse events through AE documentation based on the adverse impact of surgical site infections (German: CDC Kriterien)	8 weeks
Secondary	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