FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/04/107859 [Registered on: 08/04/2026] Trial Registered Prospectively
Last Modified On: 07/04/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Can superoxide solution irrigation during surgery help prevent wound infection? 
Scientific Title of Study   Role of intraoperative incision irrigation with super-oxidized solution in reducing surgical site infection. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Karamjot Singh Sandhu 
Designation  Assistant professor, General Surgery Dept. GMC Patiala 
Affiliation  GMC and Rajindra Hospital, Patiala,Punjab 
Address  Department of General Surgery, GMC and Rajindra hospital, Patiala, Punjab.
Department of General Surgery, GMC and Rajindra hospital, Patiala, Punjab.
Patiala
PUNJAB
147001
India 
Phone  8360049266  
Fax    
Email  sandhukss@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Karamjot Singh Sandhu 
Designation  Assistant professor, General Surgery Dept. GMC Patiala 
Affiliation  GMC and Rajindra Hospital, Patiala,Punjab 
Address  Department of General Surgery, GMC and Rajindra hospital, Patiala, Punjab.
Department of General Surgery, GMC and Rajindra hospital, Patiala, Punjab.
Patiala
PUNJAB
147001
India 
Phone  8360049266  
Fax    
Email  sandhukss@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Karamjot Singh Sandhu 
Designation  Assistant professor, General Surgery Dept. GMC Patiala 
Affiliation  GMC and Rajindra Hospital, Patiala,Punjab 
Address  Department of General Surgery, GMC and Rajindra hospital, Patiala, Punjab.
Department of General Surgery, GMC and Rajindra hospital, Patiala, Punjab.
Patiala
PUNJAB
147001
India 
Phone  8360049266  
Fax    
Email  sandhukss@gmail.com  
 
Source of Monetary or Material Support  
MRU, Government medical college, Patiala, Punjab Pin code- 147001 
 
Primary Sponsor  
Name  DHR 
Address  2nd floor, IRCS building, 1, Redcross road, New Delhi- 110001 
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 
Karamjot Singh Sandhu  Government Medical College and Rajindra Hospital, Patiala  Department of General Surgery, GMC and Rajindra hospital, Patiala, Punjab.
Patiala
PUNJAB 
8360049266

sandhukss@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: O||Medical and Surgical, (2) ICD-10 Condition: L768||Other intraoperative and postprocedural complications of skin and subcutaneous tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intra-operative incision irrigation with super-oxidized solution.  Patients undergoing exploratory laparotomy will undergo intra-operative incision irrigation with super-oxidized solution(Oxum)before closure of skin and will be compared with the control group for SSI. 
Comparator Agent  Intraoperative incision irrigation with Normal saline.  patients undergoing exploratory laparotomy will undergo intraoperative incision irrigation with Normal saline for control group and will be compared with intervention group for SSI. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Inclusion criteria for both irrigation and control groups are identical: Patients with age more than or equal to 18 years to 70 years old undergoing laparotomy for abdominal pathology causing contaminated or dirty wounds will be included. 
 
ExclusionCriteria 
Details  Laparoscopic operations, trauma patients and patient with pregnancy. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
30 day SSI as per CDC criteria  3rd day,7th day, 14th day, 30th day  
 
Secondary Outcome  
Outcome  TimePoints 
wound complications, antibiotic duration, hospital stay and re-intervention.  30 days 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
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)   20/04/2026 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Surgical site infections are among the most common complications after abdominal surgery, especially in emergency laparotomy where rates can reach up to 40 percent. These infections increase morbidity, prolong hospital stay, raise readmission rates and healthcare costs. Although several preventive strategies exist, the role of super oxidized solution for intraoperative incision irrigation remains unclear.

 

This prospective randomized study will include 180 adult patients undergoing emergency exploratory laparotomy for contaminated or dirty abdominal wounds. Patients will be randomly allocated into two groups of 90 each. Group A will receive incision wound irrigation with 100 to 300 ml of super oxidized solution before closure. Group B will receive 1000 to 1500 ml of normal saline irrigation before closure. All other perioperative management including antibiotics, skin preparation, suturing technique and postoperative care will be standardized.

 

The primary outcome will be 30 day surgical site infection based on CDC criteria. Secondary outcomes will include wound dehiscence, hematoma, seroma, duration of antibiotic use, readmission, reoperation and length of hospital stay. Statistical analysis will be performed using intention to treat principles with appropriate comparative tests and multivariate logistic regression.

 

The study is novel because evidence on super oxidized solution for intraoperative incision irrigation is limited. It aims to determine whether its use can significantly reduce surgical site infections in emergency laparotomy patients.

 
Close