Informations générales (source: ClinicalTrials.gov)
VACuum-Assisted Closure for Necrotizing Soft Tissue infecTIONs
Interventional
N/A
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
décembre 2021
juin 2025
11 septembre 2025
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.
Etablissements
Critères
Tous
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
- 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
- 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