| CTRI Number |
CTRI/2026/04/107917 [Registered on: 09/04/2026] Trial Registered Prospectively |
| Last Modified On: |
09/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to improve healing and prevent infection after belly surgery. |
|
Scientific Title of Study
|
An international cohort study of Wound Closure and Surgical Site Infection Prevention Strategies in Abdominal Surgery |
| Trial Acronym |
Wolverine |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ISRCTN55324472 |
ISRCTN |
| v0.1 dated 01 june 2025 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Parvez David Haque |
| Designation |
Professor |
| Affiliation |
Christian Medical College Hospital Ludhiana |
| Address |
Department of General Surgery
Room no 1138, first floor
Ludhiana
PUNJAB
141008
India |
| Phone |
9872630178 |
| Fax |
|
| Email |
pdhaque@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parvez David Haque |
| Designation |
Professor |
| Affiliation |
Christian Medical College Hospital Ludhiana |
| Address |
Department of General Surgery
Room no 1138, first floor
PUNJAB
141008
India |
| Phone |
9872630178 |
| Fax |
|
| Email |
pdhaque@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parvez David Haque |
| Designation |
Professor |
| Affiliation |
Christian Medical College Hospital Ludhiana |
| Address |
Department of General Surgery
Room no 1138, first floor
PUNJAB
141008
India |
| Phone |
9872630178 |
| Fax |
|
| Email |
pdhaque@gmail.com |
|
|
Source of Monetary or Material Support
|
| University of Birmingham
Research Strategy & Services Division
University of Birmingham
97 Vincent Drive
Edgbaston
Birmingham
B15 2SQ
researchgovernance@contacts.bham.ac.uk |
|
|
Primary Sponsor
|
| Name |
University of Birmingham |
| Address |
Research Strategy & Services Division University of Birmingham 97 Vincent Drive Edgbaston Birmingham B15 2SQ researchgovernance@contacts.bham.ac.uk |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India
Argentina
Belarus
Belgium
Bulgaria
Denmark
Egypt
Ethiopia
Germany
Greece
Iraq
Ireland
Israel
Italy
Kazakhstan
Latvia
Lithuania
Nigeria
Portugal
Saudi Arabia
Spain
Sri Lanka
Turkey |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Abhilash Goyal |
All India Institute of Medical Sciences |
Department of General Surgery, AIIMS Guwahati, Changsari, 781101
Kamrup
ASSAM |
8375879225
abhilashgoyal@aiimsguwahati.ac.in |
|
|
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: K929||Disease of digestive system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
- Adult patients (age 18 years and 85) undergoing general or colorectal
surgical procedures
- Elective (planned admission), expedited (within two weeks), or emergency (unplanned
admission) surgery.
- General and colorectal procedures using any type of abdominal incision measuring at least 5 cm (including extraction sites).
- Able to give written informed consent |
|
| ExclusionCriteria |
| Details |
- Patients undergoing incisional, ventral, umbilical, and inguinal/femoral hernia repair
- Simultaneous hyperthermic intraperitoneal chemotherapy (HIPEC) and/or cytoreductive
surgery
-Stoma reversal without additional laparotomy incision |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
- Patient, disease and operation-related factors including detailed information on wound closure techniques and SSI prevention measures.
- Clinician-derived surgical outcomes data for up to 30 days post-operation.
- Time-specific data collected on wound healing, post-operative recovery
and return to normal activities, re-admissions and re-operations, development of
incisional hernia at one year. |
- 30 day follow up
- one year follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
- Length of postoperative hospital stay
- Reoperations within 30 days
- 30-day mortality
- ICU admission related to SSI
- Unplanned readmissions
- Need for interventional radiology procedures
- Abdominal wound dehiscence
Surgical site occurrences (SSO).
- Patient-reported wound healing and recovery
- Return to normal activities / work
- Quality of life (EQ-5D-5L)
-Patient-reported outcome measures
|
- 30 day follow up
- One year follow up |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="300"
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) |
01/01/2026 |
| 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)
|
Open to Recruitment |
| 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
|
An international cohort study of Wound Closure and
Surgical Site Infection Prevention Strategies in Abdominal Surgery
Background: The 2021 ESCP Wound Closure Survey found
significant heterogeneity in common practices for abdominal wound closure and SSI prevention,
including various types of fascial closure techniques and suture used, skin preparation and
sterility measures taken during the surgical intervention.
Aim: To conduct a prospective, international cohort study in
wound closure and SSI prevention following abdominal surgery. An international network will
deliver the cohort study and collate clinical information on wound closure practices used and
patients will provide their own short and longer-term outcomes on wound healing, recovery and return
to normal function.
The data will also be used to inform the design of a future
interventional trial on wound closure and SSI prevention.
Design: The study has two separate components:
1) Clinical data collection: clinician-derived baseline
clinical data and short-term 30-day outcomes for patients undergoing elective and/or emergency
general and colorectal surgery.
2) Cohort study: patient-reported additional outcome data
for the period from 30 days to one year after surgery in the identical cohort of patients,
provided that patient level informed consent is obtained.
This protocol describes the cohort study.:
Centre eligibility: Any hospital or surgical unit performing
elective and/or emergency general and colorectal surgery.
Patient eligibility: Adults (age 18 years and 85) undergoing
surgery by abdominal approach are eligible, including elective, expedited or
emergency surgery by open, laparoscopic or robotic approaches with a minimum (extraction) incision
length of 5 cm.
Key outcome measures: - Patient, disease and operation-related factors
including detailed information on wound closure techniques and SSI prevention
measures.
- Clinician-derived surgical outcomes data for up
to 30 days post-operation.
- Patient-reported outcomes data at five time
points: 30, 60 and 90 days, 6 and12-months post- operation.
Time-specific data collected on wound healing, post-operative recovery and
return to normal activities, re-admissions and re-operations, development of incisional hernia at one year.
Sample size: Based on previous studies, 1,000 patients are
expected to participate in the cohort study. |