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
|
|
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
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - NIL
- 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.
- 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 |