| CTRI Number |
CTRI/2022/01/039649 [Registered on: 21/01/2022] Trial Registered Prospectively |
| Last Modified On: |
11/03/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Skin and soft tissue infection in ICU patients: a prospective multi-national cohort study |
|
Scientific Title of Study
|
SKin and soft tissue necrotizing INfections in the Intensive Care Unit: a prospective multi-national cohort study (SKIN-ICU) |
| Trial Acronym |
SKIN-ICU |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT05116956 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohan Gurjar |
| Designation |
Professor |
| Affiliation |
Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS) |
| Address |
Department of Critical Care Medicine
Room number 4
Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)
Raebareli Road,
Lucknow
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
0522-2495403 |
| Fax |
|
| Email |
m.gurjar@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohan Gurjar |
| Designation |
Professor |
| Affiliation |
Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS) |
| Address |
Department of Critical Care Medicine
Room number 4
Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)
Raebareli Road,
Lucknow
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
0522-2495403 |
| Fax |
|
| Email |
m.gurjar@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohan Gurjar |
| Designation |
Professor |
| Affiliation |
Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS) |
| Address |
Department of Critical Care Medicine
Room number 4
Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)
Raebareli Road,
Lucknow
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
0522-2495403 |
| Fax |
|
| Email |
m.gurjar@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow 226014 |
|
|
Primary Sponsor
|
| Name |
Assistance Publique Hopitaux de Paris |
| Address |
Hopital Henri Mondor
Assistance Publique Hopitaux de Paris
University Paris Est Cre teil
France
|
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Netherlands
Belgium
Brazil
Denmark
France
Germany
Hungary
India
Italy
Japan
Poland
Portugal
Spain
Sweden
Switzerland
United Kingdom
United States of America
Australia |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ritu Singh |
Indira Gandhi Institute of Medical Sciences |
Indira Gandhi Institute of Medical Sciences
Patna
Patna
BIHAR |
8127395753
ritusingh140@gmail.com |
| Dr Rupali Patnaik |
Institute of Medical Sciences and SUM Hospital |
Institute of Medical Sciences and SUM Hospital
Bhubaneswar
Khordha
ORISSA |
8921354225
rupali.patnaik87@gmail.com |
| Prof Shwethapriya Rao |
Kasturba Medical College and Kasturba Hospital |
Kasturba Medical College, Manipal 576104
Udupi
KARNATAKA |
9964668404
shwethapriya.rao@manipal.edu |
| Dr Sai Saran |
King George Medical University |
King George Medical University
Lucknow
Lucknow
UTTAR PRADESH |
8004505719
saisaranpv@gmail.com |
| Prof Anshul Jain |
Maharani Laxmi Bai Medical College |
Maharani Laxmi Bai Medical College
Jhansi
284128
Jhansi
UTTAR PRADESH |
9411685406
dranshuljain81@gmail.com |
| Dr Mohan Gurjar |
Sanjay Gandhi Postgraduate Institute of Medical Sciences |
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lucknow
226014
Lucknow
UTTAR PRADESH |
5222495403
m.gurjar@rediffmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee IMSSUM |
Approved |
| Institutional Ethics Committee IGIMS |
Approved |
| Institutional Ethics Committee KGMU |
Approved |
| Institutional Ethics Committee KMC |
Approved |
| Institutional Ethics Committee MLBMC |
Approved |
| Institutional Ethics Committee SGPGIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L00-L08||Infections of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
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)
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mortality at day 90 |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Six-month mortality |
6 months |
| Functional outcomes and HR-QoL at 6 months |
6 months |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/01/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
28/01/2022 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |