| CTRI Number |
CTRI/2025/02/080665 [Registered on: 17/02/2025] Trial Registered Prospectively |
| Last Modified On: |
17/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Examining the effects of Intraoperative wound wash with Normal Saline in patients undergoing abdominal surgeries vs no wash and to look for surgical site infection |
|
Scientific Title of Study
|
Assessing the impact of Intraoperative wound irrigation (IOWI) with Normal saline on incisional surgical site infections (SSI) in patients with laparotomy abdominal incisional wounds when compared to no irrigation: A two arm parallel randomized control trial at a tertiary care centre. |
| 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 Moonmoon Kedia |
| Designation |
Post graduate junior resident |
| Affiliation |
AIIMS, Raipur |
| Address |
Department of General Surgery D block, All India Institute Of Medical Sciences, Gate no. 4, Tatibandh, Raipur, Chhattisgarh
Raipur
CHHATTISGARH
492099
India
Raipur
CHHATTISGARH
492099
India |
| Phone |
9401202628 |
| Fax |
|
| Email |
drmunmun360@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chetan Anand |
| Designation |
Assistant Proffessor, Department of General Surgery |
| Affiliation |
AIIMS RAIPUR |
| Address |
Department of General Surgery D block, All India Institute Of Medical Sciences, Gate no. 4, Tatibandh, Raipur, Chhattisgarh
Raipur
CHHATTISGARH
492099
India
Raipur
CHHATTISGARH
492099
India |
| Phone |
848916712 |
| Fax |
|
| Email |
drchetananand@aiimsraipur.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chetan Anand |
| Designation |
Assistant Proffessor, Department of General Surgery |
| Affiliation |
AIIMS RAIPUR |
| Address |
Department of General Surgery D block, All India Institute Of Medical Sciences, Gate no. 4, Tatibandh, Raipur, Chhattisgarh
Raipur
CHHATTISGARH
492099
India
Raipur
CHHATTISGARH
492099
India |
| Phone |
848916712 |
| Fax |
|
| Email |
drchetananand@aiimsraipur.edu.in |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Medical Sciences, Raipur, Chhattisgarh- 492099 |
|
|
Primary Sponsor
|
| Name |
All India Institute Of Medical Sciences Raipur Chhattisgarh |
| Address |
Office of general surgery, D block, 4th floor, Aiims Raipur, Tatibandh, Raipur-492099 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Moonmoon Kedia |
All India Institute of Medical Sciences, Raipur |
D block, Department of General Surgery, All India Institute of Medical Sciences, Raipur, Chhattisgarh- 492099
Raipur
CHHATTISGARH |
9401202628
drmunmun360@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
| Institute Ethics Committee, AIIMS Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K389||Disease of appendix, unspecified, (2) ICD-10 Condition: K639||Disease of intestine, unspecified, (3) ICD-10 Condition: K319||Disease of stomach and duodenum, unspecified, (4) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, (5) ICD-10 Condition: C260||Malignant neoplasm of intestinal tract, part unspecified, (6) ICD-10 Condition: O348||Maternal care for other abnormalities of pelvic organs, (7) ICD-10 Condition: O||Medical and Surgical, (8) ICD-10 Condition: K315||Obstruction of duodenum, (9) ICD-10 Condition: N998||Other intraoperative and postprocedural complications and disorders of genitourinary system, (10) ICD-10 Condition: K768||Other specified diseases of liver, (11) ICD-10 Condition: K659||Peritonitis, unspecified, (12) ICD-10 Condition: K461||Unspecified abdominal hernia withgangrene, (13) ICD-10 Condition: K460||Unspecified abdominal hernia withobstruction, without gangrene, (14) ICD-10 Condition: K469||Unspecified abdominal hernia without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Irrigation of Abdominal laparotomy wound with Normal saline |
After Rectus Sheath closure, irrigation of the surgical wound with 0.9% NS intraoperatively |
| Comparator Agent |
Normal closure of surgical wound |
After rectus sheath closure, wound will be closed as per protocol without NS irrigation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients aged 18 years and more
2. Abdominal wounds after rectus sheath closure |
|
| ExclusionCriteria |
| Details |
1. Relaparotomy wounds in the same hospital stay/admission
2. Abdominal/ laparotomy wound where delayed primary closure is done |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of surgical site infection will be assessed in patients with abdominal laparotomy wound |
Post operative day 1,2,3,4,5,30 and at the time of discharge and suture removal |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Length of hospital stay
2. Pain score using VAS |
30 days |
|
|
Target Sample Size
|
Total Sample Size="244"
Sample Size from India="244"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
28/02/2025 |
| 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 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
|
All the patients undergoing Abdominal surgeries in the department of General Surgery, Obstetrics and gynaecology will be recruited in this study. After taking informed consent a detailed case proforma will be filled with relevant details and parameters as per study protocol. All patients will receive preop antibiotics as per the antibiotic policy of the hospital. All the patients will have their peritoneum closed as usual and before skin closure sequentially numbered opaque sealed envelope will be opened to reveal allocation, whether group A or group B • In Group A, wound irrigation will be done with normal saline • In Group B, wound will not be irrigated with normal saline • Post surgery follow up will be monitored and recorded for SSI according to CDC guidelines • The details of the participants will entered in the clear case record proforma • The follow up will be done till POD-30 • In case of early discharge the patient will be seen in the OPD or if not mandatory on OPD when scheduled, they will be followed telephonically |