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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
A Prevena Plus DuoTM Dressing Kit (KCI) is applied on the surgical wound at the end of surgery.
A standard dry sterile dressingwith non-adherent absorbent pad is applied on the surgical wound at the end of surgery
Lausanne University Hospital
Lausanne, Canton of Vaud, Switzerland
RECRUITINGDischarge 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)
Time frame: Day 7- Day 8
Complications
Occurrence of post-operative complications from Day 0 to hospital discharge (or max Day 14)
Time frame: 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)
Time frame: Day 0 - Day 14
Hospitalisation
Duration of hospitalisation from Day 0 to end of hospitalisation (in days)
Time frame: 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.
Time frame: 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)
Time frame: 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).
Time frame: Day 0 - Day 14
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