| CTRI Number |
CTRI/2022/03/041303 [Registered on: 23/03/2022] Trial Registered Prospectively |
| Last Modified On: |
21/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A randomised study of surgical site wound Infection in a tertiary care hospital |
|
Scientific Title of Study
|
Clinicoepidemiological and Clinicobacteriological profile of Surgical site wound infection:A randomised study in a tertiary care hospital. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sandip Sarkar |
| Designation |
Post Graduate Trainee |
| Affiliation |
Medinipur Medical College |
| Address |
Department of General Surgery
Medinipur Medical College
Medinipur
WEST BENGAL
721101
India |
| Phone |
08759958095 |
| Fax |
|
| Email |
sandipsarkar583@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subhendu Bikas Saha |
| Designation |
Associate Professor |
| Affiliation |
Medinipur Medical College |
| Address |
Medinipur Medical College
Paschim Medinipur
Pin-721101
Medinipur
WEST BENGAL
721101
India |
| Phone |
08759958095 |
| Fax |
|
| Email |
sunsubg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sandip Sarkar |
| Designation |
Post Graduate Trainee |
| Affiliation |
Medinipur Medical College |
| Address |
Department of General Surgery
Medinipur Medical College
Paschim Medinipur
Pin-721101
Medinipur
WEST BENGAL
721101
India |
| Phone |
08759958095 |
| Fax |
|
| Email |
sandipsarkar583@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sandip Sarkar
Department of General Surgery
Medinipur Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Sandip Sarkar |
| Address |
Room no 69
Old Boys Hostel
Medinipur Medical College
Paschim Medinipur
Pin 721101 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Sandip Sarkar |
Department of General Surgery ,Medinipur Medical College and Hospital |
West Medinipur
Pin 721101
Medinipur
WEST BENGAL |
8759958095
sandipsarkar583@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
12.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Admitted patients in surgical ward of our hospital who will undergo operative procedure including minimally invasive procedures. |
|
| ExclusionCriteria |
| Details |
1.Wounds other than any surgical procedure
2.Referred patients with surgical wounds
3.Patients not willing to participate in the study
4.OPD patients with healed or infected wounds. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Estimation of frequency of surgical site wound infection.
2.Risk factors
3.Bacteria involved in infection to be find out.
4.Rational use of antibiotics. |
1 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Estimation of frequency of surgical site wound infection.
2.Risk factors for Surgical site wound infection
3.Bacteria involved in infection to be find out.
4.Rational use of antibiotics. |
7days follow up
30 days follow up |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
01/04/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
An infection that occurs within 30days after operation(90days for deep organ space)and involves the skin along with sub cutaneous tissue of the incision/deep soft tissue of the incision/any part of the body other than incision that was manipulated during an operation is known as surgical site infection.It can be superficial,deep and organ space.The global estimate of SSI varied from 0.5%to 15%,in India it ranges from 20%to 38%.This variability is due to difference in characteristics of hospitals population,underlying disease,difference in clinical procedure,emergency or elective surgery.The extent of infection controll measures and hospital environment essentially add to these influencing factors.Postoperative surgical site infection is one of the major cause of post operative morbidity and mortality. They cause huge economic burden also.This study will focus on identification of several contributing factors which will certainly help in minimising incidence of SSI and will reduce economic burden,will improve postoperative quality of life. |