Clinical Trial Comparing Negative Pressure Wound Therapy and Standard Dry Dressings

Not Applicable

• Conditions: Prosthesis-Related Infections; Arthroplasty Complications; Amputation
• Interventions: Device: Dry dressing; Device: Prevena TM

• Registration Number: NCT04520841
• Lead Sponsor: University of Lausanne Hospitals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-01
• Study First Submitted: 2020-07-15
• Study First Submitted QC: 2020-08-18
• Study First Posted: 2020-08-20
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-23
• Last Update Posted: 2022-05-25
• Primary Completion: 2023-06-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard dry dressing in lower limb amputation	Dry dressing	Standard dressing in lower limb amputation: a dry sterile dressing is applied on the surgical wound at the end of surgery
Prevena in lower limb amputation	Prevena TM	Prevena incision management system in lower limb amputation: The Prevena incision management system is applied on the surgical wound at the end of surgery
Standard dry dressing in total hip or knee arthroplasty	Dry dressing	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 in total hip or knee arthroplasty	Prevena TM	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

Primary Outcome Measures

Name	Time	Method
Discharge after 7 days	Day 7- Day 8	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

Name	Time	Method
Revision surgery	Day 0 - Day 14	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	Day 0 - Day 14	Duration of hospitalisation from Day 0 to end of hospitalisation (in days)
Complications	Day 0 - Day 14	Occurrence of post-operative complications from Day 0 to hospital discharge (or max Day 14)
Patient satisfaction	Day 7	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.
AE & ADE	Day 0 - Day 14	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).
Costs	Day 0 - Day 7	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)

Trial Locations

Locations (1)

Lausanne University Hospital; 🇨🇭 Lausanne, Vaud, Switzerland