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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prevena TM | Device | A Prevena Plus DuoTM Dressing Kit (KCI) is applied on the surgical wound at the end of surgery. |
|
| 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 |
| 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) |
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Inclusion Criteria:
Signed informed consent
Age ≥ 18 years old
Planned Surgery :
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sylvain Steinmetz, MD | Contact | +41 (0)21 314 27 89 | sylvain.steinmetz@chuv.ch | |
| Diane Wernly, MD | Contact | +41 (0)76 581 49 73 | wernly.diane@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Sylvain Steinmetz, MD | Lausanne University Hospital (Switzerland) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lausanne University Hospital | Recruiting | Lausanne | Canton of Vaud | 1011 | Switzerland |
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| ID | Term |
|---|---|
| D016459 | Prosthesis-Related Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Dry dressing | Device | A standard dry sterile dressingwith non-adherent absorbent pad is applied on the surgical wound at the end of surgery |
|
| 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 |