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

March 9, 2020 updated by: Ulf Teichgräber, Jena University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Thuringia
      • Jena, Thuringia, Germany, 07747
        • University Hospital Jena

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Suture
Skin incision closure with standard subcuticular technique
Procedure: Suture
Skin incision closure with standard subcuticular technique
Active Comparator: Experimental: Histoacryl®
Skin incision closure with topic skin adhesive Histoacryl®
Device: Experimental: Histoacryl®
Skin incision closure with topic skin adhesive Histoacryl® Flexible (n-Butyl-2-Cyanoacrylate Monomer)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infection rate
Time Frame: 8 weeks
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 Frame: 10 minutes
Time measurement by stopwatch and exact documentation of intervention time of subcutaneous suture and skin closure time
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jena University Hospital

Collaborators

Aesculap AG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

August 17, 2015

First Submitted That Met QC Criteria

September 15, 2015

First Posted (Estimate)

September 16, 2015

Study Record Updates

Last Update Posted (Actual)

March 11, 2020

Last Update Submitted That Met QC Criteria

March 9, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4164-07/14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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