VACATION: VACuum-Assisted Closure for Necrotizing Soft Tissue infecTIONs

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05071443

Collaborator

(none)

130

Enrollment

Location

Arms

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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:

may accelerate skin grafting and complete wound healing; and 2) improve functional outcomes.

Condition or Disease	Intervention/Treatment	Phase
Necrotising Soft Tissue Infections	Other: Negative pressure wound therapy (NPWT) Other: Conventional dressing	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

130 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

This committee comprises experts (a dermatologist, a plastic surgeon, and a nurse specialized in wound care) tasked with validating in a consistent manner, blinded to the randomization arm, the aspect of the primary endpoint relating to cutaneous healing, based on standard photographs taken on a weekly basis by the clinical research nurse. Photographs will be made available to members of the adjudication committee through an online platform (Dispose AP-HP) or a digital support.

Primary Purpose:

Treatment

Official Title:

VACuum-Assisted Closure for Necrotizing Soft Tissue infecTIONs

Anticipated Study Start Date :

Dec 1, 2021

Anticipated Primary Completion Date :

Mar 1, 2025

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Negative pressure wound therapy (NPWT) Negative pressure wound therapy (NPWT): an NPWT device will be applied hermetically from randomization to skin grafting.	Other: 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.
Active Comparator: Conventional dressing Conventional dressing will be performed from randomization to skin grafting. The dressings will be performed following usual procedures of investigating centers	Other: Conventional dressing 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.

Arm

Intervention/Treatment

Experimental: Negative pressure wound therapy (NPWT)

Negative pressure wound therapy (NPWT): an NPWT device will be applied hermetically from randomization to skin grafting.

Other: 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.

Active Comparator: Conventional dressing

Conventional dressing will be performed from randomization to skin grafting. The dressings will be performed following usual procedures of investigating centers

Other: Conventional dressing

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.

Outcome Measures

Primary Outcome Measures

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. [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

Secondary Outcome Measures

Activities of Daily Living score [at Day 0, 3 months and 6 months]
Short Form - 36 [at Day 0, 3 months and 6 months]
Pain assessment [between Day 0 and 3 months]
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
Quantification of the number of anesthesia procedures (general anesthesia, sedation) [between Day 0 and 6 months]
Time elapsed between randomization and skin grafting [between Day 0 and 6 months]
Number of local superinfection episodes [between Day 0 and 3 months]
Quantification of the walking capacity [at 3 months and 6 months]
measured over one week with a pedometer by the research nurse, at 3 and 6 months
Duration of hospital stay [between Day 0 and 6 months]
Quantification of the time needed for each wound care before randomization and skin grafting [between Day 0 and 6 months]
this measure will be recorded once a week for one wound care
Need for stopping the NPWT [between Day 0 and 3 months]
Number of surgeries performed between randomization and skin grafting [between Day 0 and 6 months]
All surgeries will be recorded, including their date and indication
Number of surgeries performed after skin grafting [between Day 0 and 6 months]
All surgeries will be recorded, including their date and indication, all surgeries will be recorded, including their date and indication
Mortality assessed [at 3 months and 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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
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