| CTRI Number |
CTRI/2024/09/074165 [Registered on: 23/09/2024] Trial Registered Prospectively |
| Last Modified On: |
17/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Wound Infection Rates: Negative Pressure Therapy vs. Standard Dressings in closed laparotomy incisions |
|
Scientific Title of Study
|
Comparison of surgical site infection between negative pressure wound therapy and standard dressing on closed midline incisions in Class 3 and 4 abdominal surgical wounds: A Randomized control trial |
| 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 Manav Bansal |
| Designation |
Post graduate student |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Department of general surgery, Lady Hardinge Medical College, Shahid Bhagat Singh marg, Delhi
Central DELHI 110001 India |
| Phone |
8826443664 |
| Fax |
|
| Email |
manav27bansal@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Saurabh Borgharia |
| Designation |
Professor |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Department of general surgery, Lady Hardinge Medical College, Shahid Bhagat Singh marg, Delhi
Central DELHI 110001 India |
| Phone |
9810203804 |
| Fax |
|
| Email |
saurabhborgharia@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Saurabh Borgharia |
| Designation |
Professor |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Department of general surgery, Lady Hardinge Medical College, Shahid Bhagat Singh marg, Delhi
Central DELHI 110001 India |
| Phone |
9810203804 |
| Fax |
|
| Email |
saurabhborgharia@gmail.com |
|
|
Source of Monetary or Material Support
|
| lady hardinge medical college,Shaheed Bhagat Singh Marg, DIZ Area, Connaught Place, New Delhi, Delhi 110001 |
|
|
Primary Sponsor
|
| Name |
Lady hardinge medical college New Delhi |
| Address |
Department of general surgery Lady Hardinge Medical College Shaheed Bhagat Singh Marg DIZ Area, Connaught Place New Delhi India 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 |
| Dr Manav Bansal |
Lady Hardinge Medical College |
Department of general surgery, Lady Hardinge Medical college and associated hospitals, New Delhi Central DELHI |
8826443664
manav27bansal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Lady Hardinge medical college and associated hospitals, new delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K65||Peritonitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Negative pressure wound therapy device |
just after the procedure and skin closure, the NPWT dressing will be applied and continuous negative pressure of -125 mmHg will be applied. The NPWT dressing will be checked regularly for any leakage |
| Comparator Agent |
Standard dressing |
In the standard arm, standard daily dressing will be done using dry sterile gauge pieces and normal saline. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.All Adult patients undergoing laparotomy with midline incisions with class 3 surgical midline wounds.
2.All Adult patients undergoing laparotomy with midline incisions with class 4 surgical midline wounds. |
|
| ExclusionCriteria |
| Details |
1.Women with pregnancy
2.Patients allergic to adhesive materials
3.Patients undergoing reexploration for complications of previous surgery. |
|
|
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 (SSI) between negative pressure wound therapy (NPWT) versus standard dressings in closed midline incisions in patients undergoing laparotomy with class 3 and 4 abdominal surgical wounds |
1.Post op day 5 or earlier as determined by physician.
2.weekly till Post op day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Wound complications (i.e., dehiscence, hematoma, bleeding, seroma, blisters) between negative pressure wound therapy (NPWT) versus standard dressings in closed midline incisions in patients undergoing laparotomy with class 3 and 4 abdominal surgical wounds |
POD 1-5 |
| Length of hospital stay between negative pressure wound therapy (NPWT) versus standard dressings in closed midline incisions in patients undergoing laparotomy with class 3 and 4 abdominal surgical wounds |
until discharge |
| Number of patients who required hospital readmissions within 30 days between negative pressure wound therapy (NPWT) versus standard dressings in closed midline incisions in patients undergoing laparotomy with class 3 and 4 abdominal surgical wounds. |
POD30 |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
28/09/2024 |
| 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="1" Months="5" 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
|
Despite peri-operative preventive measures to minimize the risk of SSI, such as hand hygiene of the surgical team, antibiotic prophylaxis, skin preparation, and sterile drapes and gowns SSI remains a challenging problem to surgeons and patients worldwide. SSIs prolong hospitalization, increase the risk of morbidity and mortality and need for repeat surgery thereby increasing healthcare costs and form a major burden on the health infrastructure. Prophylactic negative pressure wound therapy (pNPWT) uses a closed, sealed device that is packed with porous foam or gauze dressing and sealed with an occlusive drape and continuous negative pressure rates of between-50 to -125 mm Hg maintained by connecting suction tubes to the dressing . It enhances wound healing by reducing dead space, oedema and exudates , hastening granulation tissue formation, decreasing bacterial burden, providing a moist wound healing environment and increasing blood circulation by angiogenesis. WHO panel guidelines suggest the use of negative pressure wound therapy (NPWT) in adult patients on primarily closed surgical incisions in high-risk wounds, for the purpose of the prevention of SSI. Justification:While there has been extensive research on the beneficial effects of negative pressure wound therapy on open wounds such as diabetic foot and non-healing ulcers, there are few studies which evaluated the effects of negative pressure wound therapy on closed midline incisions in patients undergoing laparotomy with grossly contaminated abdominal surgeries Standard dressing involves use of dry sterile gauge pieces. WHO panel suggests against using any type of advanced dressings over a standard dressing on primarily closed surgical wounds for the purpose of preventing SSI. Although the use of NPWT has conventionally been researched in open wounds, their use on closed laparotomy wounds has been found to be associated with a significant reduction in SSI rates. This will lead to a reduction in the overall economic burden and complications following laparotomy by decreasing length of hospital stay and reducing the number of readmissions and need for re-exploration |