Effect of Negative Pressure Wound Therapy After Surgical Removal of Deep-Seated High-Malignant Soft Tissue Sarcomas of the Extremities and Trunk Wall.
1 other identifier
interventional
160
1 country
2
Brief Summary
The purpose of this research project is to improve the surgical treatment of Soft Tissue Sarcoma (STS) treatment based upon a Randomized Controlled Trial (RCT). We want to evaluate the effect of the use of Negative Pressure Wound Therapy (NPWT) versus a conventional wound dressing on postoperative wound complications after surgical removal of deep-seated high-malignant STS of the extremities or trunk wall.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2021
Longer than P75 for not_applicable
2 active sites
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
First Submitted
Initial submission to the registry
May 26, 2021
CompletedStudy Start
First participant enrolled
July 1, 2021
CompletedFirst Posted
Study publicly available on registry
July 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedJuly 6, 2022
July 1, 2022
2.4 years
May 26, 2021
July 1, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Wound complication/healing
A major wound complication defined as in O'Sullivan et al. \[11\]: * A secondary surgery under anesthesia for wound repairs such as debridement, operative drainage and secondary wound closure. * Wound management without secondary surgery, this includes invasive procedure without anesthesia such as aspiration of seroma and readmission for wound care such as intravenous antibiotic or persistent deep packing within 4 months (120 days) after surgery.
120 days postoperatively
Secondary Outcomes (8)
Secondary outcome measures, hospital stay.
1 year postoperatively
Secondary outcome measures, readmission.
1 year postoperatively
Secondary outcome measures, primary wound healing.
1 year postoperatively
Secondary outcome measures, deep infection.
1 year postoperatively
Secondary outcome measures, seroma.
1 year postoperatively
- +3 more secondary outcomes
Study Arms (2)
Standard treatment
NO INTERVENTIONGroup A: Standard wound closure with staples and conventional wound dressing.
Prevena
EXPERIMENTALGroup B: Wound closure with staples and Negative Pressure Wound Therapy (PREVENA PLUS™ Incision Management System).
Interventions
RCT (no blinding) where the patients will be randomized to wound closure with staples and either Negative Pressure Wound Therapy (PREVENA PLUS™ Incision Management System) for 7 days or a conventional wound dressing.
Eligibility Criteria
You may qualify if:
- \- Surgery for a deep-seated STS of an extremity or the trunk wall at Rigshospitalet.
You may not qualify if:
- Age \< 18 years
- Wound closure not possible without plastic surgery (pedicled or free flaps)
- Low malignant (Trojani grade 1) STS or borderline tumors
- Pre- or postoperative chemotherapy
- Preoperative radiotherapy to the local site.
- Allergic or hypersensitive to acrylic adhesives or silver
- Unwilling or unable to provide informed consent
- Inability to comply with planned study procedures
- Patients with metastatic disease.
- Patients with ischemic surgery such as bypass or endovascular prosthesis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Aarhus University Hospital
Aarhus, 8200, Denmark
Rigshospitalet
Copenhagen, Denmark
Related Publications (1)
Yilmaz M, Thorn A, Sorensen MS, Jensen CL, Petersen MM. Effect of negative pressure wound therapy after surgical removal of deep-seated high-malignant soft tissue sarcomas of the extremities and trunk wall-study protocol for a randomized controlled trial. Trials. 2022 Jun 18;23(1):507. doi: 10.1186/s13063-022-06468-6.
PMID: 35717239DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea Thorn, MD
Rigshospitalet, Denmark
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD student and Medical Doctor, department of orthopedic surgery
Study Record Dates
First Submitted
May 26, 2021
First Posted
July 13, 2021
Study Start
July 1, 2021
Primary Completion
December 1, 2023
Study Completion
December 1, 2024
Last Updated
July 6, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share
The regulation from data protection regulation and data protection act will always be followed and a permission from data protection agency have been obtained (P-2021-150).