| 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
|
|
|
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
|
|
|
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. |