Skin and soft tissue infection in ICU patients: a prospective multi-national cohort study

Recruiting

Conditions: Infections of the skin and subcutaneous tissue,

Registration Number: CTRI/2022/01/039649

Lead Sponsor: Assistance Publique Hopitaux de Paris

Brief Summary: Necrotizing soft-tissue infections (NSTI) are rare and life-threatening bacterial infections characterized by subcutaneous tissue, fascia or muscle necrosis. Few studies have been performed and our current knowledge on NSTI is mostly derived from retrospective single center studies. The current study (SKIN-ICU) is a multinational prospective non-interventional cohort study that will include patients admitted to the intensive care units (ICU) for NSTI. The primary outcome is mortality at 90 days. Secondary outcome will includes functional outcome and quality of life at 6 months. This will be largest prospective study on NSTI, and expected to include 1000 patients worldwide including India, over 2 years of study duration.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 1000

Inclusion Criteria

1.Age > 18 years 2.Patient with surgically-confirmed NSTI (i.e., macroscopic appearance of tissue during surgery revealing swollen, dull gray tissues with a thin, brownish exudate with or without necrosis).

Exclusion Criteria

Not provided

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality at day 90	3 months

Secondary Outcome Measures

Name	Time	Method
Six-month mortality	6 months
Functional outcomes and HR-QoL at 6 months	6 months

Trial Locations

Locations (6): Indira Gandhi Institute of Medical Sciences
🇮🇳
Patna, BIHAR, India
Institute of Medical Sciences and SUM Hospital
🇮🇳
Khordha, ORISSA, India
Kasturba Medical College and Kasturba Hospital
🇮🇳
Udupi, KARNATAKA, India
King George Medical University
🇮🇳
Lucknow, UTTAR PRADESH, India
Maharani Laxmi Bai Medical College
🇮🇳
Jhansi, UTTAR PRADESH, India
Sanjay Gandhi Postgraduate Institute of Medical Sciences
🇮🇳
Lucknow, UTTAR PRADESH, India
Indira Gandhi Institute of Medical Sciences
🇮🇳Patna, BIHAR, India
Dr Ritu Singh
Principal investigator
8127395753
ritusingh140@gmail.com