| CTRI Number |
CTRI/2024/07/070606 [Registered on: 15/07/2024] Trial Registered Prospectively |
| Last Modified On: |
12/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Wound Closure and Surgical Site Infection |
|
Scientific Title of Study
|
To Study the impact of changing the surgical team and instruments for wound closure on surgical site infection(SSI) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manjesh Kumar H |
| Designation |
Junior Resident |
| Affiliation |
PGIMER,Chandigarh |
| Address |
Department Of General Surgery,
5th Level,B Block,Nehru Hospital,
PGIMER,Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7903707291 |
| Fax |
|
| Email |
manjeshkumar468@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Cherring Tandup |
| Designation |
Associate Professor |
| Affiliation |
PGIMER,Chandigarh |
| Address |
Department Of General Surgery,
5th Level,B Block,Nehru Hospital,
PGIMER,Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8196991007 |
| Fax |
|
| Email |
ctandup@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Cherring Tandup |
| Designation |
Associate Professor |
| Affiliation |
PGIMER,Chandigarh |
| Address |
Department Of General Surgery,
5th Level,B Block,Nehru Hospital,
PGIMER,Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8196991007 |
| Fax |
|
| Email |
ctandup@gmail.com |
|
|
Source of Monetary or Material Support
|
| Postgraduate Institute Of Medical Education and Research ,Chandigarh
Sector-12,
160012,
Chandigarh |
|
|
Primary Sponsor
|
| Name |
Postgraduate Institute Of Medical Education and Research |
| Address |
Postgraduate Institute Of Medical Education and Research,
Sector -12,
Chandigarh,
160012. |
| 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 Manjesh Kumar H |
Postgraduate Institute Of Medical Education and Research |
Department Of General Surgery,
5th Level,B block,
Nehru Hospital.
Chandigarh
CHANDIGARH |
7903707291
manjeshkumar468@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(intramural),Postgraduate Institute Of Medical Education & Research,Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Changing the surgical team and instruments |
After the primary task is done each patient will be assigned one of the two groups through use of set of sealed envelope method of generated random numbers.In the baseline group closure of abdominal wall and skin will be performed by main surgical team, the same team that performed the whole surgery.In the intervention group closure will be performed by second surgical team with new sterile instrument.Timing of intervention will be during intraoperative wound closure only. |
| Comparator Agent |
Surgical site infection |
The baseline group will be the same team but will use new sterile gloves during sheath closure. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to give consent,patients undergoing all major abdominal surgeries including upper and lower gastrointestinal surgery,heparopancreatico biliary surgeries.duration of surgery should be more than three hour |
|
| ExclusionCriteria |
| Details |
Patients not willing to give consent,immunocompromised patients including poorly controlled diabetes mellitus, long standing steroid treatment,obese patient |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the impact of changing surgical team and instruments for wound closure on surgical site infection |
Till 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study the length of hospital stay
2.To study rate of Rehospitalisation
3.To study 30 day mortality
4.To study the impact of surgical timing on wound infection |
Till 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
23/07/2024 |
| 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="0"
Months="11"
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 - NO
|
|
Brief Summary
|
Surgical site infections (SSI) are the most common and financially burdensome infections acquired within hospital environments. Mortality within the 30-days of surgery ranks as the third most substantial contributor to global mortality. The purpose of this study is to see whether the rate of surgical site infection can be reduced by changing the surgical team and instruments during closure of wound.
|