search
Back to results

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

Primary Purpose

Arthroplasty Complications, Amputation, Prosthesis-Related Infections

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Prevena TM
Dry dressing
Sponsored by
University of Lausanne Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthroplasty Complications focused on measuring Prevena, Negative Pressure Wound Therapy, Revision Arthroplasty, Lower Extremity Amputation Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Lausanne University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

Standard dry dressing in total hip or knee arthroplasty

Prevena in total hip or knee arthroplasty

Standard dry dressing in lower limb amputation

Prevena in lower limb amputation

Arm 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

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

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Complications
Occurrence of post-operative complications from Day 0 to hospital discharge (or max 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)
Hospitalisation
Duration of hospitalisation from Day 0 to end of hospitalisation (in days)
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.
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)
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).

Full Information

First Posted
July 15, 2020
Last Updated
May 23, 2022
Sponsor
University of Lausanne Hospitals
search

1. Study Identification

Unique Protocol Identification Number
NCT04520841
Brief Title
Clinical Trial Comparing Negative Pressure Wound Therapy and Standard Dry Dressings
Acronym
BERLYTZ
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lausanne Hospitals

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthroplasty Complications, Amputation, Prosthesis-Related Infections
Keywords
Prevena, Negative Pressure Wound Therapy, Revision Arthroplasty, Lower Extremity Amputation Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard dry dressing in total hip or knee arthroplasty
Arm Type
Active Comparator
Arm 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
Arm Title
Prevena in total hip or knee arthroplasty
Arm Type
Experimental
Arm 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
Arm Title
Standard dry dressing in lower limb amputation
Arm Type
Active Comparator
Arm Description
Standard dressing in lower limb amputation: a dry sterile dressing is applied on the surgical wound at the end of surgery
Arm Title
Prevena in lower limb amputation
Arm Type
Experimental
Arm 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
Intervention Type
Device
Intervention Name(s)
Prevena TM
Intervention Description
A Prevena Plus DuoTM Dressing Kit (KCI) is applied on the surgical wound at the end of surgery.
Intervention Type
Device
Intervention Name(s)
Dry dressing
Intervention Description
A standard dry sterile dressingwith non-adherent absorbent pad is applied on the surgical wound at the end of surgery
Primary Outcome Measure Information:
Title
Discharge after 7 days
Description
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)
Time Frame
Day 7- Day 8
Secondary Outcome Measure Information:
Title
Complications
Description
Occurrence of post-operative complications from Day 0 to hospital discharge (or max Day 14)
Time Frame
Day 0 - Day 14
Title
Revision surgery
Description
Occurrence of revision surgery due to persistent discharge from the day of the operation (Day 0) until discharge from hospital (or max Day 14)
Time Frame
Day 0 - Day 14
Title
Hospitalisation
Description
Duration of hospitalisation from Day 0 to end of hospitalisation (in days)
Time Frame
Day 0 - Day 14
Title
Patient satisfaction
Description
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.
Time Frame
Day 7
Title
Costs
Description
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)
Time Frame
Day 0 - Day 7
Title
AE & ADE
Description
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).
Time Frame
Day 0 - Day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Signed informed consent Age ≥ 18 years old Planned Surgery : revision of a hip or knee prosthesis, in 1 or 2 stages, at explantation and/or reimplantation, where 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sylvain Steinmetz, MD
Phone
+41 (0)21 314 27 89
Email
sylvain.steinmetz@chuv.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Diane Wernly, MD
Phone
+41 (0)76 581 49 73
Email
wernly.diane@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylvain Steinmetz, MD
Organizational Affiliation
Lausanne University Hospital (Switzerland)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lausanne University Hospital
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvain Steinmetz, MD
First Name & Middle Initial & Last Name & Degree
Diane Wernly, MD
First Name & Middle Initial & Last Name & Degree
Olivier Borens, PR

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Clinical Trial Comparing Negative Pressure Wound Therapy and Standard Dry Dressings

We'll reach out to this number within 24 hrs