Back to resultsIncisional Negative Pressure Wound Therapy for Resection of Soft Tissue Tumors
Primary Purpose
Soft Tissue Sarcoma, Lipoma, Tumor
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Incisional negative pressure wound therapy
Wound dressing with adhesive tapes
Sponsored by
About this trial
This is an interventional treatment trial for Soft Tissue Sarcoma
Eligibility Criteria
Inclusion Criteria:
- Soft tissue tumor of extremities or trunk with expected resection of >10cm tissue in any dimension.
Exclusion Criteria:
- No primary skin closure.
- Skin infection in area of operation (e.g. acne inversa).
Sites / Locations
- Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control group
Incisional negative pressure group
Arm Description
After subcuticular skin suture, patients receive standard dressing with adhesive wound tapes.
After subcuticular skin suture, patients receive an incisional negative pressure dressing for 5 days.
Outcomes
Primary Outcome Measures
Amount of drainage fluid
Measurement of total fluid amounts in drains and negative pressure device
Secondary Outcome Measures
Wound complications
Assessment of course of wound healing, necessary operative revisions, seroma formation
Wound margin perfusion
Measurement with laser doppler
Full Information
NCT ID
NCT03900078
First Posted
March 26, 2019
Last Updated
October 7, 2020
Sponsor
Ruhr University of Bochum
1. Study Identification
Unique Protocol Identification Number
NCT03900078
Brief Title
Incisional Negative Pressure Wound Therapy for Resection of Soft Tissue Tumors
Official Title
Inzisionelle Negative Drucktherapie Nach Resektion Von Weichteiltumoren - Eine Prospektive, Randomisierte, Kontrollierte Klinische Studie
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
August 1, 2020 (Actual)
Study Completion Date
September 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruhr University of Bochum
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is aimed to examine the value of incisional negative pressure therapy after resection of soft tissue tumors. Its a prospective randomized trial comparing incisional negative pressure to standard wound dressings.
Detailed Description
Wound healing after resection of large soft tissue tumors is often impaired by large dead space and fluid collection, potentially resulting in seroma formation and infection. Aim of the study is to compare negative pressure wound therapy to standard wound dressing in terms of quantity of drainage fluid and wound healing complications.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft Tissue Sarcoma, Lipoma, Tumor
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
RCT with two therapy arms.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
After subcuticular skin suture, patients receive standard dressing with adhesive wound tapes.
Arm Title
Incisional negative pressure group
Arm Type
Experimental
Arm Description
After subcuticular skin suture, patients receive an incisional negative pressure dressing for 5 days.
Intervention Type
Other
Intervention Name(s)
Incisional negative pressure wound therapy
Intervention Description
A negative pressure dressing is applied to the skin incision.
Intervention Type
Other
Intervention Name(s)
Wound dressing with adhesive tapes
Intervention Description
Regular adhesive wound tapes are applied over the closed skin.
Primary Outcome Measure Information:
Title
Amount of drainage fluid
Description
Measurement of total fluid amounts in drains and negative pressure device
Time Frame
up to 14 days postoperatively
Secondary Outcome Measure Information:
Title
Wound complications
Description
Assessment of course of wound healing, necessary operative revisions, seroma formation
Time Frame
3 months
Title
Wound margin perfusion
Description
Measurement with laser doppler
Time Frame
5 days postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Soft tissue tumor of extremities or trunk with expected resection of >10cm tissue in any dimension.
Exclusion Criteria:
No primary skin closure.
Skin infection in area of operation (e.g. acne inversa).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Björn Behr, MD
Organizational Affiliation
Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil Bochum
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mehran Dadras, MD
Organizational Affiliation
Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil Bochum
Official's Role
Study Director
Facility Information:
Facility Name
Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil
City
Bochum
State/Province
NRW
ZIP/Postal Code
44789
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Incisional Negative Pressure Wound Therapy for Resection of Soft Tissue Tumors
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