Comparison of Skin Adhesive to Subcuticular Suture Wound Closure After Port Placement
PWC
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
1 other identifier
interventional
128
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 17, 2015
CompletedFirst Posted
Study publicly available on registry
September 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2019
CompletedMarch 11, 2020
March 1, 2020
3.6 years
August 17, 2015
March 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Cosmetic outcome after wound healing
Wound assessment by 3 independent evaluators (surgeons) and patient himself based on photo documentation
8 weeks
Cosmetic outcome after wound healing
Patient and observer scar assessment scale (POSAS)
8 weeks
Cosmetic outcome after wound healing
Life quality questionnaire EQ5D
8 weeks
Secondary Outcomes (2)
Infection rate
8 weeks
Economy of time for wound closure
10 minutes
Study Arms (2)
Suture
ACTIVE COMPARATORSkin incision closure with standard subcuticular technique
Experimental: Histoacryl®
ACTIVE COMPARATORSkin incision closure with topic skin adhesive Histoacryl®
Interventions
Skin incision closure with topic skin adhesive Histoacryl® Flexible (n-Butyl-2-Cyanoacrylate Monomer)
Eligibility Criteria
You may qualify if:
- Medical indication for port catheter implantation because of chemotherapy or parenteral nutrition
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jena University Hospitallead
- Aesculap AGcollaborator
Study Sites (1)
University Hospital Jena
Jena, Thuringia, 07747, Germany
Related Publications (1)
Witting S, Ingwersen M, Lehmann T, Aschenbach R, Eckardt N, Zanow J, Fahrner R, Lotze S, Friedel R, Lenz M, Schmidt C, Miguel D, Ludriksone L, Teichgraber U. Wound Closure After Port Implantation-A Randomized Controlled Trial Comparing Tissue Adhesive and Intracutaneous Suturing. Dtsch Arztebl Int. 2021 Nov 5;118(44):749-755. doi: 10.3238/arztebl.m2021.0324.
PMID: 34615593DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. med.
Study Record Dates
First Submitted
August 17, 2015
First Posted
September 16, 2015
Study Start
August 1, 2015
Primary Completion
March 1, 2019
Study Completion
May 1, 2019
Last Updated
March 11, 2020
Record last verified: 2020-03