Comparison of Skin Adhesive to Subcuticular Suture Wound Closure After Port Placement (PWC)
Primary Purpose
Wound Closure After Port Catheter Implantation
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Suture
Experimental: Histoacryl®
Sponsored by
About this trial
This is an interventional treatment trial for Wound Closure After Port Catheter Implantation focused on measuring Skin Adhesive, Suture, Port Incisions
Eligibility 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
Sites / Locations
- University Hospital Jena
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Suture
Experimental: Histoacryl®
Arm Description
Skin incision closure with standard subcuticular technique
Skin incision closure with topic skin adhesive Histoacryl®
Outcomes
Primary Outcome Measures
Cosmetic outcome after wound healing
Wound assessment by 3 independent evaluators (surgeons) and patient himself based on photo documentation
Cosmetic outcome after wound healing
Patient and observer scar assessment scale (POSAS)
Cosmetic outcome after wound healing
Life quality questionnaire EQ5D
Secondary Outcome Measures
Infection rate
Assessment of adverse events through AE documentation based on the adverse impact of surgical site infections (German: CDC Kriterien)
Economy of time for wound closure
Time measurement by stopwatch and exact documentation of intervention time of subcutaneous suture and skin closure time
Full Information
NCT ID
NCT02551510
First Posted
August 17, 2015
Last Updated
March 9, 2020
Sponsor
Jena University Hospital
Collaborators
Aesculap AG
1. Study Identification
Unique Protocol Identification Number
NCT02551510
Brief Title
Comparison of Skin Adhesive to Subcuticular Suture Wound Closure After Port Placement
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
August 2015 (Actual)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
May 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jena University Hospital
Collaborators
Aesculap AG
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Closure After Port Catheter Implantation
Keywords
Skin Adhesive, Suture, Port Incisions
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
128 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Suture
Arm Type
Active Comparator
Arm Description
Skin incision closure with standard subcuticular technique
Arm Title
Experimental: Histoacryl®
Arm Type
Active Comparator
Arm Description
Skin incision closure with topic skin adhesive Histoacryl®
Intervention Type
Procedure
Intervention Name(s)
Suture
Intervention Description
Skin incision closure with standard subcuticular technique
Intervention Type
Device
Intervention Name(s)
Experimental: Histoacryl®
Intervention Description
Skin incision closure with topic skin adhesive Histoacryl® Flexible (n-Butyl-2-Cyanoacrylate Monomer)
Primary Outcome Measure Information:
Title
Cosmetic outcome after wound healing
Description
Wound assessment by 3 independent evaluators (surgeons) and patient himself based on photo documentation
Time Frame
8 weeks
Title
Cosmetic outcome after wound healing
Description
Patient and observer scar assessment scale (POSAS)
Time Frame
8 weeks
Title
Cosmetic outcome after wound healing
Description
Life quality questionnaire EQ5D
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Infection rate
Description
Assessment of adverse events through AE documentation based on the adverse impact of surgical site infections (German: CDC Kriterien)
Time Frame
8 weeks
Title
Economy of time for wound closure
Description
Time measurement by stopwatch and exact documentation of intervention time of subcutaneous suture and skin closure time
Time Frame
10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University Hospital Jena
City
Jena
State/Province
Thuringia
ZIP/Postal Code
07747
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
34615593
Citation
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.
Results Reference
derived
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Comparison of Skin Adhesive to Subcuticular Suture Wound Closure After Port Placement
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