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CTRI Number  CTRI/2023/07/055770 [Registered on: 27/07/2023] Trial Registered Prospectively
Last Modified On: 10/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Does change of Gloves before Skin closure help prevent wound infection in Emergency surgeries? 
Scientific Title of Study   Comparative Study on the effect of change of Sterile Surgical gloves before wound closure on the rate of Surgical Site Infections in patients undergoing Emergency Abdominal Exploratory laparotomy in the setup of a Tertiary care center; A Prospective 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  Dr Vipul Versi Nandu 
Designation  Assistant Professor 
Affiliation  HBT Medical College and Dr. R. N. Cooper Hospital 
Address  Department of General SUrgery, HBT Medical College and Dr. R. N. Cooper Hospital, Juhu, Vile-Parle west, Mumbai- 400056.

Mumbai (Suburban)
MAHARASHTRA
400056
India 
Phone    
Fax    
Email  dr.vipulnandu@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vipul Versi Nandu 
Designation  Assistant Professor 
Affiliation  HBT Medical College and Dr. R. N. Cooper Hospital 
Address  Department of General SUrgery, HBT Medical College and Dr. R. N. Cooper Hospital, Juhu, Vile-Parle west, Mumbai- 400056.


MAHARASHTRA
400056
India 
Phone    
Fax    
Email  dr.vipulnandu@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vipul Versi Nandu 
Designation  Assistant Professor 
Affiliation  HBT Medical College and Dr. R. N. Cooper Hospital 
Address  Department of General SUrgery, HBT Medical College and Dr. R. N. Cooper Hospital, Juhu, Vile-Parle west, Mumbai- 400056.


MAHARASHTRA
400056
India 
Phone    
Fax    
Email  dr.vipulnandu@gmail.com  
 
Source of Monetary or Material Support  
HBT Medical College and Dr. R. N. Cooper Municipal General Hospital 
 
Primary Sponsor  
Name  Government Medical College 
Address  HBT Medical College and Dr. R. N. Cooper Hospital 
Type of Sponsor  Government medical college 
 
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 
Dr Hemant Kale  HBT Medical College and Dr. R. N. Cooper hospital,   Juhu, Vile-Parle west, Mumbai.
Mumbai (Suburban)
MAHARASHTRA 
7977023286

dr.vipulnandu@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K650||Generalized (acute) peritonitis, (2) ICD-10 Condition: K566||Other and unspecified intestinal obstruction,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  group with change of gloves  second group -- change of gloves before closure of abdominal incision 
Comparator Agent  Without gloves change  Continue with same sterile gloves used during entire surgery for abdominal incision closure 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. consented for the study
2. Patient undergoing Emergency abdominal Exploratory laparotomy through midline vertical incision for abdominal pathology. 
 
ExclusionCriteria 
Details  i) Patients posted for elective/planned operations.
ii) Patients undergoing re-exploratory procedures.
iii) Immunocompromised individuals.
iv) Rest any other procedure in an Emergency setting that is done without a midline vertical incision
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
To study whether a change in gloves before wound closure helps prevent SSIs in patients undergoing Emergency Exploratory laparotomy.  2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
) To Identify the rate of SSI in emergency laparotomy procedures.  2 weeks 
2) To Compare rates of SSI in Case & control arm.  2 weeks 
3) To study the Effect of change of gloves before wound closure on rates of SSI.  2 weeks 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   09/08/2023 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

1)      Surgical site infections (SSI) are among the most common hospital-acquired infections in patients undergoing Emergency Abdominal exploratory surgeries for Bowel perforations, obstructions, etc.

2)      In recent years SSIs are accounting for 36.4% of infections reported to the Centers for Disease Control.1 Consistent with the NHSN, abdominal surgeries are the foremost common reason for SSIs accounting for nearly 50%.2

3)      SSI manifests as induration and redness of the incision site to discharge from the wound which could be of any nature from serous discharge to frank pus. This can lead to problems ranging from superficial wound gape to complete dehiscence of the abdominal wall at the site of wound closure. Depending on the grade of wound infection, it can lead to a considerable financial strain on the health care facilities as well as on the patient owing to their prolonged hospital stay, secondary dressing cost, readmission, loss of employment & disability.3

4)      A retrospective review of hospital records by Wick et al. documented 30- and 90-day readmission rates for SSIs after CRS of 11.4 and 23.3% respectively, with a median cost per event of $8885 USD.4

5)      A perioperative mortality rate for SSI of 3 percent has been reported, with 75 percent of associated deaths directly attributable to the SSI,5 its estimated that 60% of those outcomes may be prevented with the increased use of evidence-based measures.6

6)      Studies show that the implementation of a five-part bundle consisting of antibiotic prophylaxis, hair removal before surgery, perioperative normothermia, perioperative euglycemia, and operating room discipline has decreased the incidence of SSI from 22% to 11%.7

7)      Following all additives of the Bundle is challenging to comply with in an Emergency setting, subsequently raising the question of whether or not an alternate of change of gloves before skin closure, being a far more feasible factor to comply with, can lower the incidence of SSI and improve patients outcome.

8)      Abundant data have been obtained in the field of gynecology, urology & elective surgeries but the information about surgical site infection in Emergency abdominal surgeries seems to be lacking.

 
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