Amputation, Arthroplasty Complications, Prosthesis-Related Infections
Conditions
Keywords
Prevena, Negative Pressure Wound Therapy, Revision Arthroplasty, Lower Extremity Amputation Surgery
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.
Interventions
DEVICEPrevena TM
A Prevena Plus DuoTM Dressing Kit (KCI) is applied on the surgical wound at the end of surgery.
DEVICEDry dressing
A standard dry sterile dressingwith non-adherent absorbent pad is applied on the surgical wound at the end of surgery
Sponsors
University of Lausanne Hospitals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| 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). |
| 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. |
Countries
Switzerland
Contacts
Primary ContactSylvain Steinmetz, MD
Backup ContactDiane Wernly, MD
Outcome results
None listed