NCT04520841

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 15, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 20, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

May 25, 2022

Status Verified

May 1, 2022

Enrollment Period

3 years

First QC Date

July 15, 2020

Last Update Submit

May 23, 2022

Conditions

Arthroplasty ComplicationsAmputationProsthesis-Related Infections

Keywords

PrevenaNegative Pressure Wound TherapyRevision ArthroplastyLower Extremity Amputation Surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Complications

    Day 0 - Day 14

  • Revision surgery

    Day 0 - Day 14

  • Hospitalisation

    Day 0 - Day 14

  • Patient satisfaction

    Day 7

  • Costs

    Day 0 - Day 7

  • +1 more secondary outcomes

Study Arms (4)

Standard dry dressing in total hip or knee arthroplasty

ACTIVE COMPARATOR

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

Prevena in total hip or knee arthroplasty

EXPERIMENTAL

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

Standard dry dressing in lower limb amputation

ACTIVE COMPARATOR

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

Device: Dry dressing

Prevena in lower limb amputation

EXPERIMENTAL

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

Interventions

Prevena TMDEVICE

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

Prevena in lower limb amputationPrevena in total hip or knee arthroplasty
Dry dressingDEVICE

A standard dry sterile dressingwith non-adherent absorbent pad is applied on the surgical wound at the end of surgery

Standard dry dressing in lower limb amputationStandard dry dressing in total hip or knee arthroplasty

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lausanne University Hospital

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

MeSH Terms

Conditions

Prosthesis-Related Infections

Condition Hierarchy (Ancestors)

InfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sylvain Steinmetz, MD

    Lausanne University Hospital (Switzerland)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sylvain Steinmetz, MD

CONTACT

+41 (0)21 314 27 89sylvain.steinmetz@chuv.ch

Diane Wernly, MD

CONTACT

+41 (0)76 581 49 73wernly.diane@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 15, 2020

First Posted

August 20, 2020

Study Start

June 1, 2020

Primary Completion

June 1, 2023

Study Completion

June 1, 2024

Last Updated

May 25, 2022

Record last verified: 2022-05

Locations

CH(1)