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Clinical Trial Comparing Negative Pressure Wound Therapy and Standard Dry Dressings (BERLYTZ)

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ClinicalTrials.gov Identifier: NCT04520841
Recruitment Status : Recruiting
First Posted : August 20, 2020
Last Update Posted : August 20, 2020
Sponsor:
Information provided by (Responsible Party):
Sylvain Steinmetz, University of Lausanne Hospitals

Brief Summary:

Negative pressure dressings are currently widely used in wound management. Their use is gradually being extended to surgical scars. However, studies demonstrating a clear benefit are rare, particularly in terms of postoperative discharge, the need for surgical revision due to prolonged oozing and cost.

The aim of this study is to evaluate the benefit of such a device in post-operative revision prosthesis surgery (hip and knee), as well as lower limb amputations.


Condition or disease Intervention/treatment Phase
Arthroplasty Complications Amputation Prosthesis-Related Infections Device: Prevena TM Device: Dry dressing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Monocentric Randomized Clinical Trial Comparing Negative Pressure Wound Therapy (PREVENA™) and Standard Dry Dressings on Oozing of Closed Incision After Revision Total Hip and Knee Arthroplasty Surgery or Lower Extremity Amputation Surgery
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : June 1, 2023
Estimated Study Completion Date : June 1, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard dry dressing in total hip or knee arthroplasty
Standard dressing in total hip or knee arthroplasty surgery revision: a dry sterile dressing is applied on the surgical wound at the end of surgery
Device: Dry dressing
A standard dry sterile dressingwith non-adherent absorbent pad is applied on the surgical wound at the end of surgery

Experimental: Prevena in total hip or knee arthroplasty

Prevena incision management system in total hip or knee arthroplastsy surgery revision:

The Prevena incision management system is applied on the surgical wound at the end of surgery

Device: Prevena TM
A Prevena Plus DuoTM Dressing Kit (KCI) is applied on the surgical wound at the end of surgery.

Active Comparator: Standard dry dressing in lower limb amputation
Standard dressing in lower limb amputation: a dry sterile dressing is applied on the surgical wound at the end of surgery
Device: Dry dressing
A standard dry sterile dressingwith non-adherent absorbent pad is applied on the surgical wound at the end of surgery

Experimental: Prevena in lower limb amputation

Prevena incision management system in lower limb amputation:

The Prevena incision management system is applied on the surgical wound at the end of surgery

Device: Prevena TM
A Prevena Plus DuoTM Dressing Kit (KCI) is applied on the surgical wound at the end of surgery.




Primary Outcome Measures :
  1. Discharge after 7 days [ Time Frame: Day 7- Day 8 ]
    Presence of discharge at 7 days postoperatively (Day 7) Condition of the dry dressing applied on Day 7 and evaluated at least 24 hours after application (Day 8)


Secondary Outcome Measures :
  1. Complications [ Time Frame: Day 0 - Day 14 ]
    Occurrence of post-operative complications from Day 0 to hospital discharge (or max Day 14)

  2. Revision surgery [ Time Frame: Day 0 - Day 14 ]
    Occurrence of revision surgery due to persistent discharge from the day of the operation (Day 0) until discharge from hospital (or max Day 14)

  3. Hospitalisation [ Time Frame: Day 0 - Day 14 ]
    Duration of hospitalisation from Day 0 to end of hospitalisation (in days)

  4. Patient satisfaction [ Time Frame: Day 7 ]
    Reported patient satisfaction based on the responses obtained from the "Patient Evaluation Form" questionnaire completed by the patient. A numeric pain scale is included: the patient rates his pain on a scale of 0 to 10 when the last dry dressing (Opsite TM) is changed or when Prevena system (TM) is removed. Zero means "no pain," and 10 means "the worst possible pain."Participant will complete the questionnaire on Day 7.

  5. Costs [ Time Frame: Day 0 - Day 7 ]
    Dressing repair costs (sum of the price of all dressings and materials needed for dressing repair) from Day 0 to Day 7 (in Swiss francs)

  6. AE & ADE [ Time Frame: Day 0 - Day 14 ]
    Occurrence, intensity, severity, causal link with the medical device and the procedure, and characteristics of the adverse events (AEs) considered to be at least possibly related to the medical device or the procedure (= adverse events, ADEs), occurring from the day of the operation (Day 0) until discharge from hospital (or max Day 14).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Signed informed consent
  • Age ≥ 18 years old
  • Planned Surgery :

    1. revision of a hip or knee prosthesis, in 1 or 2 stages, at explantation and/or reimplantation, where
    2. elective amputation of a lower limb (transmetatarsal, trans-tibial (Burgess) or trans-femoral (Gritti-Stokes) level (nb: patients for whom amputation of both lower limbs is planned will be excluded)

Exclusion Criteria:

  • Known allergy to dry dressings
  • Patient already included in another clinical trial
  • Inability to discern and/or inability to follow study procedures
  • Known allergy to silver or another component of the system Prevena™
  • Amputation for tumor pathology

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): NCT04520841


Contacts
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Contact: Sylvain Steinmetz, MD +41 (0)21 314 27 89 sylvain.steinmetz@chuv.ch
Contact: Diane Wernly, MD +41 (0)76 581 49 73 wernly.diane@gmail.com

Locations
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Switzerland
Lausanne University Hospital Recruiting
Lausanne, Vaud, Switzerland, 1011
Contact: Sylvain Steinmetz, MD         
Principal Investigator: Diane Wernly, MD         
Principal Investigator: Olivier Borens, PR         
Sponsors and Collaborators
University of Lausanne Hospitals
Investigators
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Principal Investigator: Sylvain Steinmetz, MD Lausanne University Hospital (Switzerland)
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Responsible Party: Sylvain Steinmetz, Principal Investigator, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT04520841    
Other Study ID Numbers: 2020-00321
First Posted: August 20, 2020    Key Record Dates
Last Update Posted: August 20, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Sylvain Steinmetz, University of Lausanne Hospitals:
Prevena
Negative Pressure Wound Therapy
Revision Arthroplasty
Lower Extremity Amputation Surgery
Additional relevant MeSH terms:
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Prosthesis-Related Infections
Infections
Postoperative Complications
Pathologic Processes