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OpenTrials
Completed

NCT Number: NCT02551510

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

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.

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Key information

Conditions

Wound Closure After Port Catheter Implantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Jena

Jena, Thuringia, 07747, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Suture

Procedure

Skin incision closure with standard subcuticular technique

Experimental: Histoacryl®

Device

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

Primary outcomes

  1. Cosmetic outcome after wound healing

    Time frame: 8 weeks

    Wound assessment by 3 independent evaluators (surgeons) and patient himself based on photo documentation

  2. Cosmetic outcome after wound healing

    Time frame: 8 weeks

    Patient and observer scar assessment scale (POSAS)

  3. Cosmetic outcome after wound healing

    Time frame: 8 weeks

    Life quality questionnaire EQ5D

Secondary outcomes

  1. 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)

  2. 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

Sponsors and collaborators

Lead sponsor

Jena University Hospital

Other

Collaborators

  • Aesculap AG

Registry information

Official study 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

Acronym: PWC

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Sep 16, 2015
Registry last updated
Mar 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.