| CTRI Number |
CTRI/2016/02/006685 [Registered on: 26/02/2016] Trial Registered Retrospectively |
| Last Modified On: |
25/02/2016 |
| 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
|
comparison of surgical site infection rate in abdominal wounds using two different closure techniques |
|
Scientific Title of Study
|
Primary skin closure versus delayed primary skin closure in reducing Surgical Site Infection in dirty midline abdominal operative wounds - A randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mathews James |
| Designation |
Junior Resident |
| Affiliation |
JIPMER |
| Address |
PG Junior Resident,
Department of Surgery,
JIPMER,Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9443798545 |
| Fax |
|
| Email |
mathmoola@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Suresh Kumar |
| Designation |
Assisstant Professor |
| Affiliation |
JIPMER |
| Address |
Department of Surgery
JIPMER
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9788637893 |
| Fax |
|
| Email |
drsureshkumar08@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Suresh Kumar |
| Designation |
Assisstant Professor |
| Affiliation |
JIPMER |
| Address |
Department of Surgery
JIPMER
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9788637893 |
| Fax |
|
| Email |
drsureshkumar08@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
JIPMER,Dhanvantari Nagar,
Pondicherry |
| 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 |
| Mathews James |
JIPMER Hospital |
Room number 201,202 ; Department of General Surgery ; Institute block ; JIPMER, Dhanvantari Nagar,
Pondicherry
Pondicherry
PONDICHERRY |
9443798545
mathmoola@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee (Human Studies) Reg No :ECR/342/Inst/PY/2013 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
All patients operated for abdominal conditions in which the midline incision of the surgical wound falls into class 4 dirty abdominal wound according to the CDC classification, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Delayed primary closure |
-consent obtained and randomly allocated into this group.
-fascial closure with 1-0 prolene.
-no subcutaneous sutures.
-skin left open, packed with a sterile saline gauze.
-daily sterile dressing.
-wound evaluation after 72 hours for evidence of infection.
-skin closure with 3-0 nylon of the clean wound.
-daily dressing of infected wound and closure at a later date when wound is clean. |
| Comparator Agent |
Primary closure |
-consent obtained and random allocation.
-fascial closure with 1-0 prolene.
-no subcutaneous sutures.
-saline irrigation of the wound followed by skin closure with 3-0 nylon.
-wound cleaned with surgical spirit and sterile dressing applied.
-dressing opened after 24-48 hours to check for immediate wound complications. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All patients operated for abdominal conditions in general surgery in which surgical incision falls into class-IV- dirty abdominal wound according to CDC which includes
-Operative wound with acute purulent bacterial inflammation or perforated viscus
-Operative wound where clean tissue is transected to gain access to a collection of pus
-Fecal contamination
-Retained devitalized tissue
-Traumatic wound with delayed treatment ( after 4 hours)
-Traumatic wound from dirty source/ Operative wound dirty
-Retained foreign body |
|
| ExclusionCriteria |
| Details |
-Patient’s refusal
-Patient treated outside before coming to the hospital
-Patients requires re-exploration in the same hospital admission
-Patients in whom primary rectus closure is not possible or in whom laparostoma is warranted
-patient expires before discharge
-patient less than 18 years of age |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| -Incidence of surgical site infection and degree of SSI (superficial incisional/ deep incisional) as per the definition of CDC in each group . |
-during hospital stay
-at discharge
-at first visit
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-Length of hospital stay in days
-Postoperative pain: third and fifth postoperative day
-Patient satisfaction at the time of discharge from the hospital and at the first visit and after one month following discharge
-Cosmetic outcome and scar appearance of the wound |
-at third and fifth post operative days
-at discharge
-at first visit
-at one month following discharge |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
26/02/2014 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The primary purpose of this study is to find out a better method of skin closure in dirty abdominal wounds with respect to surgical site infection. Surgical site infection is rampant in class 4 dirty abdominal operative wounds. Many interventions have been successfully tried in reducing their incidence including prophylactic antibiotics, depilation of surgical site etc. Recently interest has been in the method of skin closure, where dirty skin wounds are left open for daily sterile dressing until the wound is clean enough to be closed. A few studies conducted in this field yielded results in favour of delayed primary skin closure to primary skin closure. But a meta analyses found heterogeneity in most studies and warranted more studies. The hypothesis of our study was that delayed primary closure is superior to primary closure in reducing surgical site infection in dirty midline laporotomy wounds. |