Necrotising Soft Tissue InfectionsVACATIONNCT05071443
VACuum-Assisted Closure for Necrotizing Soft Tissue infecTIONs
A study testing Negative pressure wound therapy (NPWT) and Conventional dressing in people with Necrotising Soft Tissue Infections, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Intro: Necrotizing and soft tissue infections (NSTI) are life-threatening bacterial infections characterized by subcutaneous tissue, fascia or muscle necrosis. The hospital mortality of NSTI is high, comprised between 20 and 30%. NSTIs represent the 4th cause of septic shock. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Necrotising Soft Tissue Infections
- What is being tested?
- Negative pressure wound therapy (NPWT) and Conventional dressing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2021to 1 Jun 2025
- 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
- Age ≥ 18 years
- Written informed consent
- NSTI/NF of the lower limb clinically suspected and confirmed by surgery with a first debridement performed since 5 days or more
- Infection considered controlled (i.e., no more surgical debridement is necessary)
- Last debridement performed at least 72 hours before
- Affiliation to a social security system
Who cannot join
- Limited life expectancy
- NPWT already initiated for the current NSTI/NF episode
- 1st surgical debridement performed less than 5 days or more than 15 days before
- High risk of bleeding (blood vessels exposed)
- Local neoplasia
- Risk of organ or peripheral nerve injury
Show all 12Show fewer
- Impossibility to set up a NPWT dressing hermetically
- Limb amputation
- Patient unable to walk without help
- Women who are pregnant or are breast-feeding, or are of childbearing age and do not use or do not plan to use acceptable birth control measures
- Patients under legal protection
- Prisoners
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique Hôpitaux de Paris - CHU Henri Mondor
Créteil, 94010 Créteil Cedex
Nicolas DE PROST, MD, PhD, 1 49 81 23 89 ext. :+ 33, nicolas.de-prost@aphp.fr
About this study
Intro: Necrotizing and soft tissue infections (NSTI) are life-threatening bacterial infections characterized by subcutaneous tissue, fascia or muscle necrosis. The hospital mortality of NSTI is high, comprised between 20 and 30%. NSTIs represent the 4th cause of septic shock. Early management of NSTIs requires a coordinated and multidisciplinary approach, including broad-spectrum antibiotic administration, management of organ failures and aggressive surgical debridement with excision of all necrotic and infected tissues. NSTIs involve the lower limbs in about 70% of cases and lead in 15% of cases to limb amputation. During the early post-operative phase, daily wound care is required using conventional dressings. As soon as the infectious process is controlled, typically within 7 to 10 days of the initial debridement, the main goal of wound dressing is to allow for a granulation tissue to develop so that to perform a skin grafting. Negative pressure wound therapy (NPWT), which consists in applying a negative pressure on the wound surface, may be used to this effect. A dedicated dressing is connected to a device that generates a negative pressure and collects exudates. NPWT may have a positive effect on wound healing by removing exudate, increasing regional perfusion and patient comfort and reducing infections. Beneficial effects of NPWT have been suggested by case series. However, no randomized controlled trial are currently available to adequately assess its efficiency and the 2014 guidelines of the Infectious Diseases Society of America (IDSA) on NSTI did not provide recommendations regarding NPWT use for managing NSTI wounds. The study's hypothesis is that in patients managed for NSTIs, NPWT: 1) may accelerate skin grafting and complete wound healing; and 2) improve functional outcomes.
Read the detailed description
Hypothesis/Objective: To demonstrate in patients who underwent a surgical debridement of the lower limb for NSTI a superiority of a wound dressing strategy using NPWT (intervention) as compared with conventional wound dressing on local healing (complete) and the recovery of walking.
Method: Open-label randomized controlled trial with blinded assessment of the primary end point. Randomization in two arms: experimental group (NPWT) versus control group (conventional dressing) until skin grafting (decided by the attending surgeon).
- Conditions
- Necrotising Soft Tissue Infections
- Being tested
- Negative pressure wound therapy (NPWT), Conventional dressing
- Keywords
- Necrotising soft tissue infections, Necrotising fasciitis, Negative pressure wound therapy
- Medical subject headings
- Fasciitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative pressure wound therapy (NPWT)Other
The therapeutic intervention being tested is the use of a negative pressure wound therapy (NPWT) device. Several medical devices are currently being used and are based on the same principle. They involve applying negative pressure, generally between -100 and -150 mmHg, to a wound using a dressing (mostly a polyurethane foam dressing with hydrophobic pores), which hermetically covers the wound's surface and is connected to a container for collecting the fluids drained off. These devices are widely available and used to treat post-operative wounds.
Duration of treatment: the use of NPWT will be maintained until the recovery of the skin has been achieved by the skin graft. An average duration of 3 weeks' treatment is expected in the intervention group.
Conventional dressingOther
Conventional dressings will be performed from randomization to skin grafting and applied every day based on the methods normally used in the participating centres, and also until the recovery of the skin has been achieved by the skin graft.
This generally involves local care provided on a daily basis, ensuring gentle mechanical and chemical debridement by covering the wound with alginate type or other dressings, according to the condition of the wound. The methods used to apply these conventional dressings will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Negative pressure wound therapy (NPWT) | Experimental | Negative pressure wound therapy (NPWT): an NPWT device will be applied hermetically from randomization to skin grafting. Receives: Other: Negative pressure wound therapy (NPWT) |
| Conventional dressing | Active comparator | Conventional dressing will be performed from randomization to skin grafting. The dressings will be performed following usual procedures of investigating centers Receives: Other: Conventional dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time elapsed between randomization and the onset of a combined outcome measure including a complete healing of the diseased limb and the recovery of walking.
Complete healing of the diseased limb is defined by more than 90% of functional skin covering the wound and Recovery of walking is defined by the ability to walk at least 100 steps, corresponding to approximately 30 meters, without help
Measured: between Day 0 and 3 months
Secondary outcomes (13)
Activities of Daily Living score
Measured: at Day 0, 3 months and 6 months
Short Form - 36
Measured: at Day 0, 3 months and 6 months
Pain assessment
Pain assessment at each wound care by the patient (visual analogic scale), the nurse (behavioral pain scale) and quantification of morphine consumption (in morphine base equivalent): measured by the investigator at each wound care
Measured: between Day 0 and 3 months
Quantification of the number of anesthesia procedures (general anesthesia, sedation)
Measured: between Day 0 and 6 months
Time elapsed between randomization and skin grafting
Measured: between Day 0 and 6 months
Number of local superinfection episodes
Measured: between Day 0 and 3 months
Quantification of the walking capacity
measured over one week with a pedometer by the research nurse, at 3 and 6 months
Measured: at 3 months and 6 months
Duration of hospital stay
Measured: between Day 0 and 6 months
Quantification of the time needed for each wound care before randomization and skin grafting
this measure will be recorded once a week for one wound care
Measured: between Day 0 and 6 months
Need for stopping the NPWT
Measured: between Day 0 and 3 months
Number of surgeries performed between randomization and skin grafting
All surgeries will be recorded, including their date and indication
Measured: between Day 0 and 6 months
Number of surgeries performed after skin grafting
All surgeries will be recorded, including their date and indication, all surgeries will be recorded, including their date and indication
Measured: between Day 0 and 6 months
Mortality assessed
Measured: at 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start1 Dec 2021 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotising Soft Tissue InfectionsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas DE PROST, MD, PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05071443
- Sponsor's protocol ID
- APHP200021
- Acronym
- VACATION
- Status last verified
- Jul 2021
- First submitted
- 19 Jul 2021
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VACuum-Assisted Closure for Necrotizing Soft Tissue infecTIONs
- ClinicalTrials.gov ID
- NCT05071443
- Acronym / sponsor ID
- VACATION / APHP200021
- Conditions
- Necrotising Soft Tissue Infections
- Keywords
- Necrotising soft tissue infections, Necrotising fasciitis, Negative pressure wound therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 8 Oct 2021 (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.
Intro: Necrotizing and soft tissue infections (NSTI) are life-threatening bacterial infections characterized by subcutaneous tissue, fascia or muscle necrosis. The hospital mortality of NSTI is high, comprised between 20 and 30%. NSTIs represent the 4th cause of septic shock. Early management of NSTIs requires a coordinated and multidisciplinary approach, including broad-spectrum antibiotic administration, management of organ failures and aggressive surgical debridement with excision of all necrotic and infected tissues. NSTIs involve the lower limbs in about 70% of cases and lead in 15% of cases to limb amputation. During the early post-operative phase, daily wound care is required using conventional dressings. As soon as the infectious process is controlled, typically within 7 to 10 days of the initial debridement, the main goal of wound dressing is to allow for a granulation tissue to develop so that to perform a skin grafting. Negative pressure wound therapy (NPWT), which consists in applying a negative pressure on the wound surface, may be used to this effect. A dedicated dressing is connected to a device that generates a negative pressure and collects exudates. NPWT may have a positive effect on wound healing by removing exudate, increasing regional perfusion and patient comfort and reducing infections. Beneficial effects of NPWT have been suggested by case series. However, no randomized controlled trial are currently available to adequately assess its efficiency and the 2014 guidelines of the Infectious Diseases Society of America (IDSA) on NSTI did not provide recommendations regarding NPWT use for managing NSTI wounds. The study's hypothesis is that in patients managed for NSTIs, NPWT: 1) may accelerate skin grafting and complete wound healing; and 2) improve functional outcomes.
Detailed description
Hypothesis/Objective: To demonstrate in patients who underwent a surgical debridement of the lower limb for NSTI a superiority of a wound dressing strategy using NPWT (intervention) as compared with conventional wound dressing on local healing (complete) and the recovery of walking.
Method: Open-label randomized controlled trial with blinded assessment of the primary end point. Randomization in two arms: experimental group (NPWT) versus control group (conventional dressing) until skin grafting (decided by the attending surgeon).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Negative pressure wound therapy (NPWT) | Experimental | Other: Negative pressure wound therapy (NPWT)Negative pressure wound therapy (NPWT): an NPWT device will be applied hermetically from randomization to skin grafting. |
| Conventional dressing | Active comparator | Other: Conventional dressingConventional dressing will be performed from randomization to skin grafting. The dressings will be performed following usual procedures of investigating centers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Written informed consent
- NSTI/NF of the lower limb clinically suspected and confirmed by surgery with a first debridement performed since 5 days or more
- Infection considered controlled (i.e., no more surgical debridement is necessary)
- Last debridement performed at least 72 hours before
Key exclusion criteria (12 listed)
- Limited life expectancy
- NPWT already initiated for the current NSTI/NF episode
- 1st surgical debridement performed less than 5 days or more than 15 days before
- High risk of bleeding (blood vessels exposed)
- Local neoplasia
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 |
|---|---|---|
| Negative pressure wound therapy (NPWT)The therapeutic intervention being tested is the use of a negative pressure wound therapy (NPWT) device. Several medical devices are currently being used and are based on the same principle. They involve applying negative pressure, generally between -100 and -150 mmHg, to a wound using a dressing (mostly a polyurethane foam dressing with hydrophobic pores), which hermetically covers the wound's surface and is connected to a container for collecting the fluids drained off. These devices are widely available and used to treat post-operative wounds. Duration of treatment: the use of NPWT will be maintained until the recovery of the skin has been achieved by the skin graft. An average duration of 3 weeks' treatment is expected in the intervention group. | Other | Negative pressure wound therapy (NPWT) |
| Conventional dressingConventional dressings will be performed from randomization to skin grafting and applied every day based on the methods normally used in the participating centres, and also until the recovery of the skin has been achieved by the skin graft. This generally involves local care provided on a daily basis, ensuring gentle mechanical and chemical debridement by covering the wound with alginate type or other dressings, according to the condition of the wound. The methods used to apply these conventional dressings will be recorded. | Other | Conventional dressing |
Primary outcome
The time elapsed between randomization and the onset of a combined outcome measure including a complete healing of the diseased limb and the recovery of walking.
Time frame: between Day 0 and 3 months
Complete healing of the diseased limb is defined by more than 90% of functional skin covering the wound and Recovery of walking is defined by the ability to walk at least 100 steps, corresponding to approximately 30 meters, without help
13 secondary outcomes
Activities of Daily Living score
Time frame: at Day 0, 3 months and 6 months
Short Form - 36
Time frame: at Day 0, 3 months and 6 months
Pain assessment
Time frame: between Day 0 and 3 months
Quantification of the number of anesthesia procedures (general anesthesia, sedation)
Time frame: between Day 0 and 6 months
Time elapsed between randomization and skin grafting
Time frame: between Day 0 and 6 months
Number of local superinfection episodes
Time frame: between Day 0 and 3 months
Quantification of the walking capacity
Time frame: at 3 months and 6 months
Duration of hospital stay
Time frame: between Day 0 and 6 months
Quantification of the time needed for each wound care before randomization and skin grafting
Time frame: between Day 0 and 6 months
Need for stopping the NPWT
Time frame: between Day 0 and 3 months
Number of surgeries performed between randomization and skin grafting
Time frame: between Day 0 and 6 months
Number of surgeries performed after skin grafting
Time frame: between Day 0 and 6 months
Mortality assessed
Time frame: at 3 months and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
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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.
Nicolas DE PROST, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Negative pressure wound therapy (NPWT) and Conventional dressing in people with Necrotising Soft Tissue Infections, run by Assistance Publique - Hôpitaux de Paris 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 6 inclusion and 12 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 Oct 2021. 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 Nicolas DE PROST, MD, PhD (1 49 81 23 89 ext. + 33, nicolas.de-prost@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time elapsed between randomization and the onset of a combined outcome measure including a complete healing of the diseased limb and the recovery of walking. (time frame: between Day 0 and 3 months). 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 8 Oct 2021.