VACuum-Assisted Closure for Necrotizing Soft Tissue infecTIONs

NCT05071443 | Unknown

• 1 other identifier: APHP200021
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Necrotising Soft Tissue Infections

Keywords

Necrotising soft tissue infections; Necrotising fasciitis; Negative pressure wound therapy

Outcome Measures

Primary Outcomes (1)

• 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

  between Day 0 and 3 months

Secondary Outcomes (13)

• 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

• 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

Study Arms (2)

Negative pressure wound therapy (NPWT)

EXPERIMENTAL

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

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

Other: Conventional dressing

Interventions

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.

Negative pressure wound therapy (NPWT)

Conventional dressing 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.

Conventional dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Limited life expectancy
• NPWT already initiated for the current NSTI/NF episode
• st 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Assistance Publique Hôpitaux de Paris - CHU Henri Mondor

Créteil, 94010 Créteil Cedex, France

Location

MeSH Terms

Conditions

Fasciitis, Necrotizing

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Study Officials

• Nicolas DE PROST, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Central Study Contacts

Nicolas DE PROST, MD, PhD

CONTACT

1 49 81 23 89; nicolas.de-prost@aphp.fr

David SCHMITZ

CONTACT

1 49 81 36 32; david.schmitz@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: October 8, 2021
• Study Start: December 1, 2021
• Primary Completion: March 1, 2025
• Study Completion: June 1, 2025
• Last Updated: October 8, 2021

Record last verified: 2021-07

Locations

FR (1)