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

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ClinicalTrials.gov Identifier: NCT02551510
Recruitment Status : Unknown
Verified September 2016 by Ulf Teichgräber, Jena University Hospital.
Recruitment status was:  Recruiting
First Posted : September 16, 2015
Last Update Posted : September 27, 2016
Sponsor:
Collaborator:
Aesculap AG
Information provided by (Responsible Party):
Ulf Teichgräber, 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.

Condition or disease Intervention/treatment Phase
Wound Closure After Port Catheter Implantation Procedure: Suture Device: Experimental: Histoacryl® Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Study Start Date : August 2015
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02551510


Contacts
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Contact: Saskia Romankiewicz +49 03641/9 324957 saskia.romankiewicz@med.uni-jena.de
Contact: Ulf Teichgräber, Prof. Dr. med. +49 03641/9 324831 ulf.teichgraeber@med.uni-jena.de

Locations
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Germany
University Hospital Jena Recruiting
Jena, Thuringia, Germany, 07747
Contact: Saskia Romankiewicz    +49-03641-9 324957    saskia.romankiewicz@med.uni-jena.de   
Contact: Laura Graziani    +49-03641-9 324910    laura.graziani@med.uni-jena.de   
Sponsors and Collaborators
Jena University Hospital
Aesculap AG

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Responsible Party: Ulf Teichgräber, Prof. Dr. med., Jena University Hospital
ClinicalTrials.gov Identifier: NCT02551510     History of Changes
Other Study ID Numbers: 4164-07/14
First Posted: September 16, 2015    Key Record Dates
Last Update Posted: September 27, 2016
Last Verified: September 2016
Keywords provided by Ulf Teichgräber, Jena University Hospital:
Skin Adhesive
Suture
Port Incisions
Additional relevant MeSH terms:
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Wounds and Injuries