Arthroplasty ComplicationsBERLYTZNCT04520841
Clinical Trial Comparing Negative Pressure Wound Therapy and Standard Dry Dressings
A study testing Prevena TM and Dry dressing in people with Arthroplasty Complications and Amputation, run by University of Lausanne Hospitals at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arthroplasty Complications, Amputation, Prosthesis-Related Infections
- What is being tested?
- Prevena TM and Dry dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2020to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Lausanne University Hospital
Lausanne, Canton of Vaud, 1011
Sylvain Steinmetz, MD
Diane Wernly, MD
About this study
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
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.
- Being tested
- Prevena TM, Dry dressing
- Keywords
- Prevena, Negative Pressure Wound Therapy, Revision Arthroplasty, Lower Extremity Amputation Surgery
- Medical subject headings
- Prosthesis-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevena TMDevice
A Prevena Plus DuoTM Dressing Kit (KCI) is applied on the surgical wound at the end of surgery.
Dry dressingDevice
A standard dry sterile dressingwith non-adherent absorbent pad is applied on the surgical wound at the end of surgery
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Dry dressing |
| 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 Receives: Device: Prevena TM |
| 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 Receives: Device: Dry dressing |
| 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 Receives: Device: Prevena TM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Day 7- Day 8
Secondary outcomes (6)
Complications
Occurrence of post-operative complications from Day 0 to hospital discharge (or max Day 14)
Measured: 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)
Measured: Day 0 - Day 14
Hospitalisation
Duration of hospitalisation from Day 0 to end of hospitalisation (in days)
Measured: 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.
Measured: 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)
Measured: 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).
Measured: Day 0 - Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start1 Jun 2020
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sylvain Steinmetz, University of Lausanne Hospitals
- Investigators
- Sylvain Steinmetz, MD, Principal investigator, Lausanne University Hospital (Switzerland)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04520841
- Sponsor's protocol ID
- 2020-00321
- Acronym
- BERLYTZ
- Status last verified
- May 2022
- First submitted
- 15 Jul 2020
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04520841
- Acronym / sponsor ID
- BERLYTZ / 2020-00321
- Keywords
- Prevena, Negative Pressure Wound Therapy, Revision Arthroplasty, Lower Extremity Amputation Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 20 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard dry dressing in total hip or knee arthroplasty | Active comparator | Device: Dry dressingStandard 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 | Device: Prevena TMPrevena 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 | Device: Dry dressingStandard 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 | Device: Prevena TMPrevena incision management system in lower limb amputation: The Prevena incision management system is applied on the surgical wound at the end of surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed informed consent
- Age ≥ 18 years old
- Planned Surgery :
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prevena TMA Prevena Plus DuoTM Dressing Kit (KCI) is applied on the surgical wound at the end of surgery. | Device | Prevena in lower limb amputation, Prevena in total hip or knee arthroplasty |
| Dry dressingA standard dry sterile dressingwith non-adherent absorbent pad is applied on the surgical wound at the end of surgery | Device | Standard dry dressing in lower limb amputation, Standard dry dressing in total hip or knee arthroplasty |
Primary outcome
Discharge after 7 days
Time frame: 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)
6 secondary outcomes
Complications
Time frame: Day 0 - Day 14
Revision surgery
Time frame: Day 0 - Day 14
Hospitalisation
Time frame: Day 0 - Day 14
Patient satisfaction
Time frame: Day 7
Costs
Time frame: Day 0 - Day 7
AE & ADE
Time frame: Day 0 - Day 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvain Steinmetz, MD principal investigator
Lausanne University Hospital (Switzerland)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prevena TM and Dry dressing in people with Arthroplasty Complications and Amputation, run by University of Lausanne Hospitals at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sylvain Steinmetz, MD (+41 (0)21 314 27 89, sylvain.steinmetz@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discharge after 7 days (time frame: Day 7- Day 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.