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CTRI Number  CTRI/2023/12/060540 [Registered on: 19/12/2023] Trial Registered Prospectively
Last Modified On: 18/12/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   The Usefulness of two techniques (Negative Pressure wound therapy vs Standard surgical dressing) of dirty laparotomy wound with respect to the incidence of infection at the surgical site. 
Scientific Title of Study   Prophylactic Negative Pressure Wound Therapy in reducing surgical site infections in dirty laparotomy wound- - A randomized controlled 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  S NANDHA KUMAR 
Designation  Junior Resident 
Affiliation  JIPMER, Puducherry 
Address  Jawaharlal Institute Of Postgraduate Medical Education And Research, Dhanvantari Nagar, Puducherry- 605006

Pondicherry
PONDICHERRY
605006
India 
Phone  6374763821  
Fax    
Email  nandhunks57@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  ANANDHI 
Designation  Consultant 
Affiliation  JIPMERJawaharlal Institute Of Postgraduate Medical Education And Research,Puducherry 
Address  Department of General Surgery, Jawaharlal Institute Of Postgraduate Medical Education And Research, Dhanvantari Nagar, Puducherry- 605006 Pondicherry PONDICHERRY 605006 India

Pondicherry
PONDICHERRY
605006
India 
Phone  7867037352  
Fax    
Email  anandhiramesh76@yahoo.in  
 
Details of Contact Person
Public Query
 
Name  S NANDHA KUMAR 
Designation  Junior Resident 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry 
Address  Jawaharlal Institute of Postgraduate Medical Education And Research, Dhanvantari Nagar, Puducherry- 605006

Pondicherry
PONDICHERRY
605006
India 
Phone  6374763821  
Fax    
Email  nandhunks57@gmail.com  
 
Source of Monetary or Material Support  
JIPMER DHANVANTARI NAGAR PONDICHERRY- 605006 
 
Primary Sponsor  
Name  S NANDHA KUMAR 
Address  Harvey hostel -2 Hostel complex JIPMER - 605006 Pondicherry 
Type of Sponsor  Other [Self ] 
 
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 
S NANDHA KUMAR  Jawaharlal Institute Post Graduate Medical Education and Research, Puducherry  Department of General Surgery 2nd Floor, Old Block Jawaharlal Institute Post Graduate Medical Education and Research, Puducherry DHANVANTARI NAGAR PONDICHERRY￾ 605006 Pondicherry
Pondicherry
PONDICHERRY 
6374763821

nandhunks57@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE (HUMAN STUDIES) JIPMER, PONDICHERRY  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K279||Peptic ulcer, site unspecified, unspecified as acute or chronic, without hemorrhage or perforation, (2) ICD-10 Condition: K461||Unspecified abdominal hernia withgangrene, (3) ICD-10 Condition: K37||Unspecified appendicitis, (4) ICD-10 Condition: K631||Perforation of intestine (nontraumatic), (5) ICD-10 Condition: K928||Other specified diseases of the digestive system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  N/A  N/A 
Intervention  Prophylactic Negative Pressure Wound Therapy in reducing surgical site infections in dirty laparotomy wound - Open-Labelled Parallel Arm Superiority Randomized, Controlled Trial.  The use of Negative Pressure Wound Therapy in closed surgical incisions may reduce fluid accumulation in the avascular dead space, limiting the development of collections and their sequela, promote increased blood flow around closed incisions, reduce shearing stress at suture lines, and increase lymphatic drainage, thereby improving wound healing and preventing associated complications. 
Intervention  Prophylactic Negative Pressure Wound Therapy in reducing surgical site infections in dirty laparotomy wound - Open-Labelled Parallel Arm Superiority Randomized, Controlled Trial.  The use of Negative Pressure Wound Therapy in closed surgical incisions may reduce fluid accumulation in the avascular dead space, limiting the development of collections and their sequela, promote increased blood flow around closed incisions, reduce shearing stress at suture lines, and increase lymphatic drainage, thereby improving wound healing and preventing associated complications. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients over 18 years of age with dirty laparotomy wound including abdominal trauma undergoing emergency laparotomy. 
 
ExclusionCriteria 
Details  1. Patients undergone previous laparotomy. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Negative Pressure Wound Therapy will
reduce the incidence of surgical site infection and the associated morbidities in patients undergoing midline laparotomy. 
Maximum of 10 days after the operation or till discharge of patient whichever is earlier. 
 
Secondary Outcome  
Outcome  TimePoints 
Participants will be assessed for scar cosmesis at 4 weeks & 12 weeks after surgery  Participants will be assessed for scar cosmesis at 4 weeks & 12 weeks after surgery 
 
Target Sample Size   Total Sample Size="132"
Sample Size from India="132" 
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   Phase 3 
Date of First Enrollment (India)   29/12/2023 
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="2"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  NIL

  6. For how long will this data be available start date provided 09-09-2025 and end date provided 01-09-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Surgical site infections are common hospital-acquired infections (HAIs) and are associated with high morbidity and mortality. Among the HAIs, Surgical Site Infection (SSI) is serious complication causing increasing morbidity and currently one of the most important among the HAIs comprising 20% of it.1,10 SSIs are responsible for an additional 7-11 days of hospital stay.19 The incidence of SSI vary widely from 3 to 34% and is responsible for considerable increase in the cost of treatment.4,6 Even when using best practices, many factors associated with SSIs are not easily modifiable, including use of neoadjuvant therapy and the length of operation. However, one actionable area is the management of surgical incision. This can be achieved by application of wound protectors, disinfectants to the skin, or specialized dressings.11,20 A majority of studies evaluating the impact of using such interventions is composed of retrospective studies, which often suffer from selection bias.

Negative-pressure wound therapy (NPWT) devices were designed to remove fluids from the incisional wound in the early postoperative phase, to reduce tensile forces across the incision and to protect the incision from external contamination. Negative pressure wound therapy (NPWT) on closed, clean incisions, has emerged as a prophylactic option to reduce the risk of SSI in high- risk incisions.15,16

Standard et al., have done a study of pNPWT in extremity fractures (open reduction and internal fixation). There was a total of 23 infections in control group and 14 in NPWT group, which represented a significant difference in favor of NPWT (p = 0.049). The relative risk of developing an infection was 1.9 times higher in control patients than in patients treated with NPWT (95% confidence interval, 1.03–3.55).13

In a study done by Shen et al., he found no significant differences in superficial SSIs (12.8% vs. 12.9%; p > 0.99) or deep SSI (3.0% vs. 3.0%; p > 0.99) rates between the SSD and NPWT groups, respectively. In the univariate and multivariate logistic regression analysis of demographic and operative factors for the development of combined incisional SSI, the only independent predictors were preoperative albumin (p = 0.0031) and type of operation (p = 0.018).21

Another prospective study evaluated healing of postoperative sternotomy wounds after their primary closure with NPWT, using continuous negative pressure of -80 mmHg in 40 patients and 40 patients in a control group in whom conventional dressings were applied in the postoperative period. They found that the number of patients in whom primary wound healing occurred without complications was significantly higher in the NPWT group versus the control group (x2 test =4.50, p=0.0339) and the number of total superficial infections was significantly smaller versus the control group (x2 test =5; p=0.0254). Antibiotic therapy was also initiated significantly less often as compared to the group treated with conventional dressings (X2 test = 4.11; p=0.0425).15 
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