Clinical Trial Comparing Negative Pressure Wound Therapy and Standard Dry Dressings
NCT ID: NCT04520841
Last Updated: 2022-05-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2020-06-01
2024-06-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Dry dressing
A standard dry sterile dressingwith non-adherent absorbent pad is applied on the surgical wound at the end of surgery
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
Prevena TM
A Prevena Plus DuoTM Dressing Kit (KCI) is applied on the surgical wound at the end of surgery.
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
Dry dressing
A standard dry sterile dressingwith non-adherent absorbent pad is applied on the surgical wound at the end of surgery
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
Prevena TM
A Prevena Plus DuoTM Dressing Kit (KCI) is applied on the surgical wound at the end of surgery.
Interventions
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Prevena TM
A Prevena Plus DuoTM Dressing Kit (KCI) is applied on the surgical wound at the end of surgery.
Dry dressing
A standard dry sterile dressingwith non-adherent absorbent pad is applied on the surgical wound at the end of surgery
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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University of Lausanne Hospitals
OTHER
Responsible Party
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Sylvain Steinmetz
Principal Investigator
Principal Investigators
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Sylvain Steinmetz, MD
Role: PRINCIPAL_INVESTIGATOR
Lausanne University Hospital (Switzerland)
Locations
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Lausanne University Hospital
Lausanne, Canton of Vaud, Switzerland
Countries
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Central Contacts
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Facility Contacts
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Sylvain Steinmetz, MD
Role: primary
Other Identifiers
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2020-00321
Identifier Type: -
Identifier Source: org_study_id
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