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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Amputation; Arthroplasty Complications; Prosthesis-Related Infections
• Intervention / Treatment: Device: Dry dressing; Device: Prevena TM

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sylvain Steinmetz, MD; Phone Number: +41 (0)21 314 27 89; Email: sylvain.steinmetz@chuv.ch
• Study Contact Backup: Name: Diane Wernly, MD; Phone Number: +41 (0)76 581 49 73; Email: wernly.diane@gmail.com

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1011
      • Recruiting
      • Lausanne University Hospital
      • Contact: Sylvain Steinmetz, MD
      • Principal Investigator: Diane Wernly, MD
      • Principal Investigator: Olivier Borens, PR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Discharge after 7 days	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)	Day 7- Day 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Occurrence of post-operative complications from Day 0 to hospital discharge (or max Day 14)	Day 0 - Day 14
Revision surgery	Occurrence of revision surgery due to persistent discharge from the day of the operation (Day 0) until discharge from hospital (or max Day 14)	Day 0 - Day 14
Hospitalisation	Duration of hospitalisation from Day 0 to end of hospitalisation (in days)	Day 0 - Day 14
Patient satisfaction	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.	Day 7
Costs	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)	Day 0 - Day 7
AE & ADE	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).	Day 0 - Day 14

Collaborators and Investigators

• Sponsor: University of Lausanne Hospitals
• Investigators: Principal Investigator: Sylvain Steinmetz, MD, Lausanne University Hospital (Switzerland)

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: July 15, 2020
• First Submitted That Met QC Criteria: August 18, 2020
• First Posted (Actual): August 20, 2020

Study Record Updates

• Last Update Posted (Actual): May 25, 2022
• Last Update Submitted That Met QC Criteria: May 23, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Prevena; Negative Pressure Wound Therapy; Revision Arthroplasty; Lower Extremity Amputation Surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Postoperative Complications; Prosthesis-Related Infections
• Other Study ID Numbers: 2020-00321

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• 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