Clinical Trial Comparing Negative Pressure Wound Therapy and Standard Dry Dressings

Amputation Clinical Trial

— BERLYTZ  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04520841
• Other study ID #: 2020-00321
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: June 1, 2024

Study information

• Verified date: May 2022
• Source: University of Lausanne Hospitals
• Contact: Sylvain Steinmetz, MD
• Phone: +41 (0)21 314 27 89
• Email: sylvain.steinmetz[@]chuv.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amputation
• Arthroplasty Complications
• Prosthesis-Related Infections

Intervention

Device:
• Prevena TM
A Prevena Plus DuoTM Dressing Kit (KCI) is applied on the surgical wound at the end of surgery.
• Dry dressing
A standard dry sterile dressingwith non-adherent absorbent pad is applied on the surgical wound at the end of surgery

Locations

Country	Name	City	State
Switzerland	Lausanne University Hospital	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Complications	Occurrence of post-operative complications from Day 0 to hospital discharge (or max Day 14)	Day 0 - Day 14
Secondary	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
Secondary	Hospitalisation	Duration of hospitalisation from Day 0 to end of hospitalisation (in days)	Day 0 - Day 14
Secondary	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
Secondary	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
Secondary	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