FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/07/071751 [Registered on: 31/07/2024] Trial Registered Prospectively
Last Modified On: 30/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Other (Specify) [Dressing of operative wounds post surgical closure]  
Study Design  Other 
Public Title of Study   Impact of dressings timing on surgical wound infections:study in patients with clean and slightly contaminated wound 
Scientific Title of Study   Comparison of Surgical site infections among patients with clean and clean contaminated wounds undergoing early vs delayed dressing removal: Randomised control study. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mohammed Aathil 
Designation  Postgraduate Junior resident 
Affiliation  AIIMS Raipur  
Address  Department of general surgery,D BLOCK,AIIMS RAIPUR,Tatibandh, GE Road, Raipur-492 099 (CG)

Raipur
CHHATTISGARH
492099
India 
Phone  9566960469  
Fax    
Email  docaathil99@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR.CHETAN ANAND 
Designation  ASSOCIATE PROFESSOR 
Affiliation  AIIMS Raipur  
Address  DEPARTMENT OF GENERAL SURGERY,D BLOCK,All India institute of medical sciences raipur Tatibandh, GE Road, Raipur-492 099 (CG)

Raipur
CHHATTISGARH
492099
India 
Phone  7898667111  
Fax    
Email  drchetananand@aiimsraipur.edu.in  
 
Details of Contact Person
Public Query  
Name  Mohammed Aathil 
Designation  Postgraduate Junior resident 
Affiliation  AIIMS Raipur  
Address  All India institute of medical sciences raipur Tatibandh, GE Road, Raipur-492 099 (CG)

Raipur
CHHATTISGARH
492099
India 
Phone  9566960469  
Fax    
Email  docaathil99@gmail.com  
 
Source of Monetary or Material Support  
AIIMS RAIPUR,DEPARTMENT OF GENERAL SURGERY,DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY,TATIBANDH,RAIPUR 492099 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [Nil] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrMohammed Aathil  ALL INDIA INSTITUTE OF MEDICAL SCIENCES,RAIPUR  ward 2a1,2a2,3a1,1b1,1b2,department ofgeneral surgery and department of obstetrics and gynaecology,Tatibandh, G E Road, Raipur, Chhattisgarh 492099
Raipur
CHHATTISGARH 		 9566960469

docaathil99@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-AIIMS RAIPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: 1||Obstetrics,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Delayed dressing removal  Permanent dressing removed anytime after 48hrs after primary closure of wound and dressing and continued at the surgeon’s discretion. 
Intervention  Early dressing removal  Permanent dressing removed in 24-48 hrs post primary closure of incised wound.No dressing applied thereafter. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All patients more than 18 years undergoing clean and clean contaminated surgeries in the department of general surgery and obstetrics and gynecology
Open and laparoscopy surgeries which are clean and clean contaminated and the incision is closed primarily
All the patients who give informed consent for participating in the study.  
 
ExclusionCriteria 
Details  Relaparotomy within 30 days of previous surgery POD 1 is Day of surgery through the same incision
Patients with HIV chronic renal failure chronic steroid intake SLE active skin infections at proposed incision site
All surgeries done under local anaesthesia
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To estimate the superficial and deep surgical site infections rates among two groups of patients early vs delayed permanent dressing removal undergoing clean and clean contaminated procedures  To estimate the superficial and deep surgical site infections rates among two groups of patients early vs delayed permanent dressing removal undergoing clean and clean contaminated procedures over period of 30days  
 
Secondary Outcome  
Outcome  TimePoints 
To assess pain score
duration of hospital stay &
wound healing assessment  		 30 days 
 
Target Sample Size   Total Sample Size="206"
Sample Size from India="206" 
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   Phase 3 
Date of First Enrollment (India)   30/08/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  nil

  6. For how long will this data be available start date provided 01-01-2025 and end date provided 01-01-2028?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   This is a randomized control study comparing surgical site infections (SSI) in patients with clean and clean-contaminated wounds undergoing early vs delayed dressing removal. early dressing removal group will have their dressing removed between 24 to 36 hours post primary closure of incision and no dressing will be done further. The delayed dressing removal group will have their dressing opened after 48 hours and dressing will be continued as per surgeon’s discretion.The study aims to determine if early permanent dressing removal is non-inferior to delayed permanent removal in terms of SSI rates. 
Close