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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
Sponsor:
Information provided by (Responsible Party):
Müjgan Yilmaz, Rigshospitalet, Denmark

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.

Condition or disease Intervention/treatment Phase
Sarcoma Cancer Neoplasms, Connective and Soft Tissue Device: Prevena Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Standard treatment
Group A: Standard wound closure with staples and conventional wound dressing.
Experimental: Prevena
Group B: Wound closure with staples and Negative Pressure Wound Therapy (PREVENA PLUS™ Incision Management System).
Device: Prevena
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.




Primary Outcome Measures :
  1. Wound complication/healing [ Time Frame: 120 days postoperatively ]

    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.


Secondary Outcome Measures :
  1. Secondary outcome measures, hospital stay. [ Time Frame: 1 year postoperatively ]
    Length of hospital stay (measured in days)

  2. Secondary outcome measures, readmission. [ Time Frame: 1 year postoperatively ]
    Readmission to hospital for treatment of a wound complication (measured in days from primary surgery)

  3. 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)

  4. 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)

  5. Secondary outcome measures, seroma. [ Time Frame: 1 year postoperatively ]
    Postoperative seroma development (measured in days from primary surgery)

  6. Secondary outcome measures, MSTS. [ Time Frame: 1 year postoperatively ]

    Musculoskeletal Tumor Society Score (MSTS)

    MSTS score is a physician-completed score containing following categories:

    • Pain
    • Function
    • Emotional acceptance
    • Support/Assistive device
    • Walking
    • Gait

    Maximum score is 30 (the value will often be presented in percentage of total).


  7. 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.


  8. 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:

    • Mobility
    • Personal hygiene
    • Usual activities
    • Pain
    • 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Surgery for a deep-seated STS of an extremity or the trunk wall at Rigshospitalet.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Contacts
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Contact: Müjgan Yilmaz, MD +45 29387478 muejgan.yilmaz.01@regionh.dk
Contact: Michael Mørk Petersen, Prof. +45 35458900 Michael.moerk.petersen@regionh.dk

Locations
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Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark
Contact: Michael Mørk Petersen, Professor         
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Principal Investigator: Müjgan Yilmaz, MD Rigshospitalet, Denmark
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Responsible Party: Müjgan Yilmaz, PhD student and Medical Doctor, department of orthopedic surgery, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT04960332    
Other Study ID Numbers: Prevena-RH-2021
First Posted: July 13, 2021    Key Record Dates
Last Update Posted: August 11, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Müjgan Yilmaz, Rigshospitalet, Denmark:
Negative Pressure Wound Therapy
Prevena
Sarcoma
Cancer
Neoplasms, Connective and Soft Tissue
Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms
Neoplasms by Histologic Type