CTRI Number |
CTRI/2023/06/054285 [Registered on: 21/06/2023] Trial Registered Prospectively |
Last Modified On: |
19/06/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cohort Study |
Study Design |
Other |
Public Title of Study
|
study of spread of infections in the surgical patients |
Scientific Title of Study
|
AN OBSERVATIONAL STUDY TO DETERMINE THE CAUSATIVE FACTORS AND TO ASSESS THE EFFECTIVENESS OF PRECAUTIONARY MEASURES FOR SURGICAL SITE INFECTION IN ELECTIVE GENERAL SURGICAL CASES |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Shashank Singh |
Designation |
POSTGRADUATE JUNIOR RESIDENT |
Affiliation |
VARUN ARJUN MEDICAL COLLEGE AND ROHILKHAND HOSPITAL, BANTHRA, SHAHJAHANPUR, UP, 242307 |
Address |
room number 178, department of general surgery, VARUN ARJUN MEDICAL COLLEGE AND ROHILKHAND HOSPITAL , BANTHRA, SHAHJAHANPUR
Shahjahanpur UTTAR PRADESH 242307 India |
Phone |
8953592005 |
Fax |
|
Email |
shashankblah@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Vishnu Sharma |
Designation |
Professor |
Affiliation |
VARUN ARJUN MEDICAL COLLEGE AND ROHILKHAND HOSPITAL, BANTHRA, SHAHJAHANPUR, UP, 242307 |
Address |
room number 178, department of general surgery , Varun Arjun medical college and Rohilkhand hospital, Banthara
Shahjahanpur UTTAR PRADESH 242307 India |
Phone |
9719836000 |
Fax |
|
Email |
surgeryVAMC34@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Shashank Singh |
Designation |
POSTGRADUATE JUNIOR RESIDENT |
Affiliation |
VARUN ARJUN MEDICAL COLLEGE AND ROHILKHAND HOSPITAL, BANTHRA, SHAHJAHANPUR, UP, 242307 |
Address |
room number 178, department of general surgery ,VARUN ARJUN MEDICAL COLLEGE AND ROHILKHAND HOSPITAL , BANTHRA, SHAHJAHANPUR
Shahjahanpur UTTAR PRADESH 242307 India |
Phone |
8953592005 |
Fax |
|
Email |
shashankblah@gmail.com |
|
Source of Monetary or Material Support
|
varun arjun medical college and rohilkhand hospital, banthra ,shahjahanpur , uttar pradesh 242307 |
|
Primary Sponsor
|
Name |
VARUN ARJUN MEDICAL COLLEGE AND ROHILKHAND HOSPITAL |
Address |
VARUN ARJUN MEDICAL COLLEGE AND ROHILKHAND HOSPITAL BANTHRA SHAHJAHANPUR UP 242307 |
Type of Sponsor |
Private medical college |
|
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 |
shashank singh |
Varun arjun medical college and Rohilkhand hospital |
room number 178, department of general surgery , Banthara Shahjahanpur UTTAR PRADESH |
8953592005
shashankblah@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTION ETHICS COMMITEE , VAMC |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Only elective general surgical cases involving clean and clean contaminated surgeries will be taken up for study.
Both sexes will be included.
18 to 60 years age groups will be included.
Patients who are willing to be part of this study will be taken.
|
|
ExclusionCriteria |
Details |
Immunocompromised patient
patients not willing to be part of the study
emergency surgeries
contaminated surgeries |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
1-to know the risk factors and causes of SSIS
2-To know the prevalance of organisms isolated from SSIs and their sensitivity to various drugs
3-to identify the methods of prevention of SSIs
4-to have a protocol for treatment of SSIS |
3 weeks, 6 weeks, 9 weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
1-to DETERMINE RISK FACTORS PLAYING ROLE IN DEVELOPMENT OF SSI
2-To know the prevelance of organisms isolated from SSIs & their sensitivity to various drugs
3-TO POSTULATE A PROTOCOL FROM THE FINDINGS OF THE STUDY FOR PREVENTION AND TREATMENT OF SSIS
4-TO ASSESS MORBIDITY AND MORTALITY OF SSIs |
3weeks, 6weeks, 9 weeks |
|
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)
|
19/07/2023 |
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="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
none |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
An elaborate study of the cases with regard to date of admission, history, clinical features date of surgery, type of surgery, emergency or elective, preoperative preparation and postoperative management will be done till patient is discharged from hospital, and then follow up the patient on OPD basis for any signs of wound infection for 1 year. The wounds will be examined for suggestive Signs/Symptoms of infection in the post-operative period, during wound dressing. In history, presenting complaints, duration, associated diseases, coexistent infections at a remote body site, personal history including diet, smoking, and alcoholism will be noted. Post-operative findings which included day of wound infection, day of 1st dressing and frequency of change of dressing. Findings on the day of diagnosis of wound infection will be noted which includes fever, erythema, discharge, type and color and the exudates collected from the depth of the wound using sterile cotton swab and sent to microbiology department for culture and sensitivity. The specimens will be collected from patients with surgical site infection in wards/OT with a sterile stick with absorbent cotton swab and sent to the microbiology laboratory for bacterial culture and sensitivity to drugs. Blood investigation like CBC will be send and if required USG will be done. |