Clinical Trial Comparing Negative Pressure Wound Therapy and Standard Dry Dressings

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Arthroplasty Complications, Amputation, Prosthesis-Related Infections

Intervention / Treatment
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* Device: Prevena TM
* Device: Dry dressing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard dry dressing in total hip or knee arthroplasty<br>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<br>* A standard dry sterile dressingwith non-adherent absorbent pad is applied on the surgical wound at the end of surgery<br>|
| Experimental: Prevena in total hip or knee arthroplasty<br>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<br>* A Prevena Plus DuoTM Dressing Kit (KCI) is applied on the surgical wound at the end of surgery.<br>|
| Active Comparator: Standard dry dressing in lower limb amputation<br>Standard dressing in lower limb amputation: a dry sterile dressing is applied on the surgical wound at the end of surgery | Device: Dry dressing<br>* A standard dry sterile dressingwith non-adherent absorbent pad is applied on the surgical wound at the end of surgery<br>|
| Experimental: Prevena in lower limb amputation<br>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<br>* A Prevena Plus DuoTM Dressing Kit (KCI) is applied on the surgical wound at the end of surgery.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevena, Negative Pressure Wound Therapy, Revision Arthroplasty, Lower Extremity Amputation Surgery