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

Lausanne University Hospital (CHUV)

Status: Enrolling

Conditions: Prosthesis-Related Infections; Amputation; Arthroplasty Complications

Treatments: Device: Prevena TM; Device: Dry dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT04520841

2020-00321

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 4 patient groups

Standard dry dressing in total hip or knee arthroplasty

Active Comparator group

Description:

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

Treatment:

Device: Dry dressing

Prevena in total hip or knee arthroplasty

Experimental group

Description:

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

Treatment:

Device: Prevena TM

Standard dry dressing in lower limb amputation

Active Comparator group

Description:

Standard dressing in lower limb amputation: a dry sterile dressing is applied on the surgical wound at the end of surgery

Treatment:

Device: Dry dressing

Prevena in lower limb amputation

Experimental group

Description:

Prevena incision management system in lower limb amputation: The Prevena incision management system is applied on the surgical wound at the end of surgery

Treatment:

Device: Prevena TM