| CTRI Number |
CTRI/2022/04/042320 [Registered on: 29/04/2022] Trial Registered Prospectively |
| Last Modified On: |
28/04/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
PROSPECTIVE SINGLE CENTRE |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of factors related to response of treatment in adult cellulitis patients. |
|
Scientific Title of Study
|
A prospective study on cellulitis in adult patients with analysis of the factors related to the response to treatment |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MUKESH KUMAR |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
IGIMS |
| Address |
WARD BLOCK, DEPT SURGERY,IGIMS PATNA
SHEKHPURA,BAILY ROAD
Patna
BIHAR
800014
India |
| Phone |
09708309952 |
| Fax |
|
| Email |
drmukeshk@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MUKESH KUMAR |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
IGIMS |
| Address |
WARD BLOCK, DEPT SURGERY,IGIMS PATNA
SHEKHPURA,BAILY ROAD
Patna
BIHAR
800014
India |
| Phone |
09708309952 |
| Fax |
|
| Email |
drmukeshk@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
MUKESH KUMAR |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
IGIMS |
| Address |
WARD BLOCK, DEPT SURGERY,IGIMS PATNA
SHEKHPURA,BAILY ROAD
Patna
BIHAR
800014
India |
| Phone |
09708309952 |
| Fax |
|
| Email |
drmukeshk@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NO |
| Address |
NO |
| Type of Sponsor |
Other [NIL] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| MUKESH KUMAR |
INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES |
WARD BLOCK, DEPT SURGERY,IGIMS PATNA
SHEKHPURA,BAILY ROAD
Patna
BIHAR |
09708309952
0612-2297225
drmukeshk@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| THE INSTITUTIONAL ETHICS COMMITTEE,IGIMS , PATNA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L039||Cellulitis and acute lymphangitis,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
AGE 18 TO 65 YRS PATIENTS WITH A DIAGNOSIS OF CELLULITIS AS PER STULBERGS CRITERIA( REDNESS, WARMTH, PAIN, AND SWELLING IN THE AFFECTED PART). |
|
| ExclusionCriteria |
| Details |
PATIENTS WHO WILL NOT GIVE CONSENT
PATIENTS WITH HIV, HBsAg, AND HCV POSITIVE |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO KNOW THE EFFECT OF VARIOUS FACTORS SUCH AS DEMOGRAPHIC, CO-MORBIDITY, CLINICAL AND TOPOGRAPHICAL, MICROBIOLOGICAL LABORATORY, IMAZING AND DURATION OF HOSPITAL STAY IN TREATMENT RESPONSE(GOOD OR POOR) OF CELLULITIS PATIENTS. |
BASELINE, 4 WKS AND 8WKS. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO KNOW THE FACTORS RELATED TO RESPONSE TO CELLULITIS TREATMENT. |
ONE YEAR |
|
|
Target Sample Size
|
Total Sample Size="100"
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)
|
08/05/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
1. Wells RD, Mason P, Roarty J, Dooley M. comparison of initial antibiotics choice and treatment of cellulitis in the pre and post-community-acquired methicillin staphylococcus eras. Am J Emerg Med 2009;27:436-439.
2. khawcharoenporn T, Tice ADS, Grandinetti A Chow D. Risk factors for community-associated methicillin-resistant staphylococcus aureus cellulitis and the value of recognition. Hawaii Med J 2010;69:232-236.
3. Mantravers P, Snauwaret A, Welsch C. Current guidelines and recommendation for the management of skin and soft tissue infections. Curr Opin Infect Dis.2016;29:131-138.
4. Cranendonk DR, Lavrijsen APM, Prins JM, Wiersina WJ. Cellulitis; current insight into pathophysiology and clinical management. Neth Med J 2017;75:366-378. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
cellulitis is a common type of skin and soft tissue infection, whose incidence is rising and results in substantial economical and healthcare burdens. the causative microorganism is not identified in most cases of cellulitis but streptococcus pyrogens, staphylococcus aureus and other streptococci are accounts for three fourth of the cases. all clinical and healthcare circumstances emphasize the value of identifying factors leading to cellulitis for prevention purposes. the identification of the factors related to the response to therapy is highly desirable to improve the management and outcome. few large series of cellulitis have been published and few studies mostly with relatively reduced sample sizes have analyzed the interactions of the multiple potential causes leading to cellulitis the clinical, microbiological and therapeutic aspects and outcomes. therefore large comprehensive, prospective studies evaluating the multiplicity of factors related to the diverse aspects of cellulitis are necessary. to this end, we have carried out a large prospective study of adults patients with cellulitis admitted to the general surgery department, Indira Gandhi Institute of medical sciences Patna. several parameters including demography, topography, predisposing factors, co-morbidities, microbiological, clinical, laboratory, imaging, outcome and treatment data will be recorded and analysed to identify the factors associated with poor responses to therapy. |