Bilateral Vascular Groin SurgeryPREVISIONNCT04174183
Evaluation of the Effectiveness of a Closed-incision Negative-pressure Therapy (Prevena®) on Bilateral Groin Incision
A study testing Closed-incision Negative-pressure Therapy - Dry dressing in people with Bilateral Vascular Groin Surgery, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Closed-incision negative-pressure therapy are medical device that are suspected to reduce groin wound complication in vascular surgery. The aim of this study is to compareon on the same patient a Closed-incision negative-pressure therapy (Prevena®, KCI) versus a traditional gauze dressings after a bilateral vascular… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bilateral Vascular Groin Surgery
- What is being tested?
- Closed-incision Negative-pressure Therapy - Dry dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- 24 Dec 2019to Jul 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Person affiliated to a health insurance system
- Person who has received full information on the organization of the research and has signed his or her informed consent
- Person presenting a bilateral vascular groin surgery
- Major person
Who cannot join
- Person with a known allergy to one of the components of the evaluated product (including: acrylic or silver-based adhesives)
- Person with a contraindication to the product(s) being evaluated
- Non-collaborative or agitated patient
- Patients with hemostasis problems
- Persons referred to in Articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code:
- Pregnant woman, parturient or breastfeeding mother
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- Minor person (not emancipated)
- Adult person subject to a legal protection measure (guardianship, curatorship, protection of justice)
- Adult person unable to consent
- Persons deprived of their liberty by a judicial or administrative decision, persons undergoing psychiatric care pursuant to Articles L. 3212-1 and L. 3213-1.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Régional Universitaire de Nancy
Vandœuvre-lès-Nancy, Grand Est, 54500
Nicla Settembre, M.D., +33 3 831 543 84, n.settembre@chru-nancy.fr
Nicla Settembre, Dr
About this study
Closed-incision negative-pressure therapy are medical device that are suspected to reduce groin wound complication in vascular surgery. The aim of this study is to compareon on the same patient a Closed-incision negative-pressure therapy (Prevena®, KCI) versus a traditional gauze dressings after a bilateral vascular groin surgery. To do this, each device is applied on one groin incision and the side, left or right, is randomized.
Read the detailed description
The prevalence of surgical site infections in groin vascular surgery is 3-44%. The factors causing these infections are well identified: disruption of lymphatic vessels, proximity of genital organs, presence of prosthetic material, etc. The risk of developing an infection of the surgical site is also influenced by the patient's comorbidities and by the surgical context.
Closed-incision negative-pressure therapy are medical device that are suspected to reduce groin wound complication in vascular surgery. The mechanisms of action for negative-pressure therapy include protecting the wound bed, splinting soft tissue, reducing oedema,increasing perfusion and enhancing development of granulation tissue.
Presently, there are no guidelines for the use of this device or not in groin incision and this decision is left to the surgeon's discretion.
The main objective is to demonstrate the superiority of closed-incision negative-pressure therapy over the application of a traditional gauze dressings to reduce the rate of major complications (i.e. requiring an extension of hospitalization time) during bilateral vascular groin surgery. To do this, each device is applied on one groin incision and the side, left or right, is randomized.
The secondary objectives are:
- To demonstrate the superiority of closed-incision negative-pressure therapy over the application of a dry dressing in reducing the score of complications (major and minor) during vascular groin surgery. The complication score is the number of complications observed during the consultation conducted on day four after the surgery, among the following:
- Major :
- Presence of pus
- Bloody and/or lymphatic discharge
- Disunity
- Necrosis
- Minor :
- Bruising 6) Hematoma 7) Wound extension
- To compare the rate of major complications between closed-incision negative-pressure therapy and dry dressing application in different clinical settings.
- To demonstrate the superiority of closed-incision negative-pressure therapy over the application of a dry dressing in reducing the score of complications 2-3 months after surgery.
- Conditions
- Bilateral Vascular Groin Surgery
- Being tested
- Closed-incision Negative-pressure Therapy - Dry dressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed-incision Negative-pressure Therapy - Dry dressingDevice
A Closed-incision Negative-pressure Therapy is applied on one groin incision - A dry dressing is applied on one groin incision .
| Study group | Role | What they receive |
|---|---|---|
| Prevena (right side) - Dry dressing (left side) | Experimental | Not described Receives: Device: Closed-incision Negative-pressure Therapy - Dry dressing |
| Prevena (left side) - Dry dressing (right side) | Experimental | Not described Receives: Device: Closed-incision Negative-pressure Therapy - Dry dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound aspect - major complication
Left and right wound incision are inspected and the presence of major complication are reported.
Major complication :
Presence of pus Bloody and/or lymphatic discharge Disunity Necrosis
Measured: 4 days
Secondary outcomes (3)
Score of complications
Left and right wound incision are inspected and the presence of major and minor complication are reported. A score of complications is established.
- Major : Presence of pus Bloody and/or lymphatic discharge Disunity Necrosis
- Minor : Bruising Hematoma Wound extension
Each complication amount to 1 point on the complication score.
Measured: 4-days
Major complication in different clinical settings
Left and right wound incision are inspected and the presence of major complication are reported.
Major complication :
Presence of pus Bloody and/or lymphatic discharge Disunity Necrosis
During the analysis, patient are divided into several group depending of the presence or absence of comorbidities.
Measured: 4-days
Wound aspect - major complication (long term)
Left and right wound incision are inspected and the presence of major complication are reported.
Major complication :
Presence of pus Bloody and/or lymphatic discharge Disunity Necrosis
Measured: 2-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start24 Dec 2019
- Primary completionJan 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bilateral Vascular Groin SurgeryStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicla Settembre, Principal investigator, Service de chirurgie vasculaire - Centre Hospitalier Régional Universitaire de Nancy - Allée du Morvan - 54511 Vandœuvre-lès-Nancy Cedex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04174183
- Sponsor's protocol ID
- 2019-A02416-51
- Acronym
- PREVISION
- Status last verified
- Oct 2019
- First submitted
- 14 Nov 2019
- Last updated
- 8 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Correia RM, Nakano LC, Vasconcelos V, Cristino MA, Flumignan RL. Prevention of infection in peripheral arterial reconstruction of the lower limb. Cochrane Database Syst Rev. 2025 Oct 29;10(10):CD015022. doi: 10.1002/14651858.CD015022.pub2.
PubMed 41159585
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of a Closed-incision Negative-pressure Therapy (Prevena®) on Bilateral Groin Incision
- ClinicalTrials.gov ID
- NCT04174183
- Acronym / sponsor ID
- PREVISION / 2019-A02416-51
- Conditions
- Bilateral Vascular Groin Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 24 Dec 2019 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 22 Nov 2019 (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.
Closed-incision negative-pressure therapy are medical device that are suspected to reduce groin wound complication in vascular surgery. The aim of this study is to compareon on the same patient a Closed-incision negative-pressure therapy (Prevena®, KCI) versus a traditional gauze dressings after a bilateral vascular groin surgery. To do this, each device is applied on one groin incision and the side, left or right, is randomized.
Detailed description
The prevalence of surgical site infections in groin vascular surgery is 3-44%. The factors causing these infections are well identified: disruption of lymphatic vessels, proximity of genital organs, presence of prosthetic material, etc. The risk of developing an infection of the surgical site is also influenced by the patient's comorbidities and by the surgical context.
Closed-incision negative-pressure therapy are medical device that are suspected to reduce groin wound complication in vascular surgery. The mechanisms of action for negative-pressure therapy include protecting the wound bed, splinting soft tissue, reducing oedema,increasing perfusion and enhancing development of granulation tissue.
Presently, there are no guidelines for the use of this device or not in groin incision and this decision is left to the surgeon's discretion.
The main objective is to demonstrate the superiority of closed-incision negative-pressure therapy over the application of a traditional gauze dressings to reduce the rate of major complications (i.e. requiring an extension of hospitalization time) during bilateral vascular groin surgery. To do this, each device is applied on one groin incision and the side, left or right, is randomized.
The secondary objectives are:
- To demonstrate the superiority of closed-incision negative-pressure therapy over the application of a dry dressing in reducing the score of complications (major and minor) during vascular groin surgery. The complication score is the number of complications observed during the consultation conducted on day four after the surgery, among the following:
- Major :
- Presence of pus
- Bloody and/or lymphatic discharge
- Disunity
- Necrosis
- Minor :
- Bruising 6) Hematoma 7) Wound extension
- To compare the rate of major complications between closed-incision negative-pressure therapy and dry dressing application in different clinical settings.
- To demonstrate the superiority of closed-incision negative-pressure therapy over the application of a dry dressing in reducing the score of complications 2-3 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prevena (right side) - Dry dressing (left side) | Experimental | Device: Closed-incision Negative-pressure Therapy - Dry dressing |
| Prevena (left side) - Dry dressing (right side) | Experimental | Device: Closed-incision Negative-pressure Therapy - Dry dressing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Person affiliated to a health insurance system
- Person who has received full information on the organization of the research and has signed his or her informed consent
- Person presenting a bilateral vascular groin surgery
- Major person
Key exclusion criteria (10 listed)
- Person with a known allergy to one of the components of the evaluated product (including: acrylic or silver-based adhesives)
- Person with a contraindication to the product(s) being evaluated
- Non-collaborative or agitated patient
- Patients with hemostasis problems
- Persons referred to in Articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code:
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 |
|---|---|---|
| Closed-incision Negative-pressure Therapy - Dry dressingA Closed-incision Negative-pressure Therapy is applied on one groin incision - A dry dressing is applied on one groin incision . | Device | Prevena (left side) - Dry dressing (right side), Prevena (right side) - Dry dressing (left side) |
Primary outcome
Wound aspect - major complication
Time frame: 4 days
Left and right wound incision are inspected and the presence of major complication are reported. Major complication : Presence of pus Bloody and/or lymphatic discharge Disunity Necrosis
3 secondary outcomes
Score of complications
Time frame: 4-days
Major complication in different clinical settings
Time frame: 4-days
Wound aspect - major complication (long term)
Time frame: 2-3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2020.
- Derived from this study: PubMed 41159585Correia RM, Nakano LC, Vasconcelos V, Cristino MA, Flumignan RL. Prevention of infection in peripheral arterial reconstruction of the lower limb. Cochrane Database Syst Rev. 2025 Oct 29;10(10):CD015022. doi: 10.1002/14651858.CD015022.pub2.
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.
Nicla Settembre principal investigator
Service de chirurgie vasculaire - Centre Hospitalier Régional Universitaire de Nancy - Allée du Morvan - 54511 Vandœuvre-lès-Nancy Cedex
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closed-incision Negative-pressure Therapy - Dry dressing in people with Bilateral Vascular Groin Surgery, run by Central Hospital, Nancy, France at 1 site in France.
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 4 inclusion and 10 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 8 May 2020. 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 France. 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 Nicla Settembre, M.D (+33 3 831 543 84, n.settembre@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound aspect - major complication (time frame: 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04174183, which also lists 1 linked publication.
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 8 May 2020.