VACuum-Assisted Closure for Necrotizing Soft Tissue infecTIONs

NCT ID: NCT05071443

Last Updated: 2021-10-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2025-06-01

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: 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).

Conditions

Necrotising Soft Tissue Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Negative pressure wound therapy (NPWT)

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

Group Type: EXPERIMENTAL

Negative pressure wound therapy (NPWT)

Intervention Type: 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 dressing

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

Group Type: ACTIVE_COMPARATOR

Conventional dressing

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicolas DE PROST, MD, PhD

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux de Paris

Locations

Assistance Publique Hôpitaux de Paris - CHU Henri Mondor

Créteil, , France

Countries

France

Central Contacts

Nicolas DE PROST, MD, PhD

Role: CONTACT

nicolas.de-prost@aphp.fr

1 49 81 23 89 ext. + 33

David SCHMITZ

Role: CONTACT

david.schmitz@aphp.fr

1 49 81 36 32 ext. + 33

Facility Contacts

Nicolas DE PROST, MD, PhD

Role: primary

nicolas.de-prost@aphp.fr

1 49 81 23 89 ext. :+ 33

Other Identifiers

APHP200021

Identifier Type: -

Identifier Source: org_study_id