Effect of Negative Pressure Wound Therapy After Surgical Removal of Deep-Seated High-Malignant Soft Tissue Sarcomas of the Extremities and Trunk Wall.
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|ClinicalTrials.gov Identifier: NCT04960332|
Recruitment Status : Recruiting
First Posted : July 13, 2021
Last Update Posted : August 11, 2021
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma Cancer Neoplasms, Connective and Soft Tissue||Device: Prevena||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Prospective randomized controlled trial|
|Masking:||None (Open Label)|
|Official Title:||Effect of Negative Pressure Wound Therapy After Surgical Removal of Deep-Seated High-Malignant Soft Tissue Sarcomas of the Extremities and Trunk Wall. A Randomized Controlled Trial|
|Actual Study Start Date :||July 1, 2021|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2024|
No Intervention: Standard treatment
Group A: Standard wound closure with staples and conventional wound dressing.
Group B: Wound closure with staples and Negative Pressure Wound Therapy (PREVENA PLUS™ Incision Management System).
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.
- Wound complication/healing [ Time Frame: 120 days postoperatively ]
A major wound complication defined as in O'Sullivan et al. :
- 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.
- Secondary outcome measures, hospital stay. [ Time Frame: 1 year postoperatively ]Length of hospital stay (measured in days)
- Secondary outcome measures, readmission. [ Time Frame: 1 year postoperatively ]Readmission to hospital for treatment of a wound complication (measured in days from primary surgery)
- Secondary outcome measures, primary wound healing. [ Time Frame: 1 year postoperatively ]Time to primary wound healing and removal of staples, ready for radiation therapy (measured in days from primary surgery)
- Secondary outcome measures, deep infection. [ Time Frame: 1 year postoperatively ]Deep infection (measured in days from primary surgery, any medical or surgical interventions will be described)
- Secondary outcome measures, seroma. [ Time Frame: 1 year postoperatively ]Postoperative seroma development (measured in days from primary surgery)
- Secondary outcome measures, MSTS. [ Time Frame: 1 year postoperatively ]
Musculoskeletal Tumor Society Score (MSTS)
MSTS score is a physician-completed score containing following categories:
- Emotional acceptance
- Support/Assistive device
Maximum score is 30 (the value will often be presented in percentage of total).
- Secondary outcome measures, TESS. [ Time Frame: 1 year postoperatively ]
Toronto Extremity Salvage Score (TESS)
TESS is a self-administrated questionnaire that evaluates physical disability, it consists of 29 questions for upper-extremity and 30 for lower-extremity. Each question is scored from 1-5, where 5 is given if there are no problems. Values will often be presented as a percentage of the total possible amount.
- Secondary outcome measures, 5Q-5D. [ Time Frame: 1 year postoperatively ]
European Quality of Life - 5 Dimensions (EQ-5D)
EQ-5D is a self-reported questionnaire to evaluate the quality of life, it has 5 dimensions:
- Personal hygiene
- Usual activities
- Anxiety/depression Each dimension is evaluated with a score of 1-5, where 1 is given to patients without problems. Each answer has a different weight in values and the values for a Danish population will be used in analysis.
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): NCT04960332
|Contact: Müjgan Yilmaz, MD||+45 email@example.com|
|Contact: Michael Mørk Petersen, Prof.||+45 35458900||Michael.firstname.lastname@example.org|
|Contact: Michael Mørk Petersen, Professor|
|Principal Investigator:||Müjgan Yilmaz, MD||Rigshospitalet, Denmark|