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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 
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