Back to resultsA Randomized Controlled Trial Evaluating the Role of Negative Pressure Wound Therapy (NPWT) for Incisional Surgical Site Infections in Patients Undergoing Hepatopancreatobiliary Surgery (NPWT)
Primary Purpose
Hepatobiliary Disease, Hepatobiliary Disorders, Surgical Site Infection
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Negative Pressure Wound Therapy
Sponsored by
About this trial
This is an interventional prevention trial for Hepatobiliary Disease focused on measuring Hepatopancreatobiliary surgery, Surgical site infection, Negative pressure wound therapy
Eligibility Criteria
Inclusion Criteria:
All patients undergoing elective open HPB surgery (benign or malignant disease) of age > 18 years consenting to the study protocol.
Exclusion Criteria:
The patient in which primary wound closure is not achieved. The patient planned for a second look surgery. The patient with the history of long-term antibiotic use (more than a month). Past history of open abdominal surgery (less than 1 month).
Sites / Locations
- Sindh Institute of Urology and Transplantation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group A
Control group B
Arm Description
After the skin closed, negative pressure wound therapy will be applied.
After the skin is closed, the wound is covered using sterile standard guaze dressing.
Outcomes
Primary Outcome Measures
Rate of incisional surgical site infections (iSSIs)
To compare the rates of incisional surgical site infections (iSSIs) within 7 days of hepatopancreatobiliary (HPB) surgery using negative pressure wound therapy (NWPT) versus using standard sterile gauze dressing.
Secondary Outcome Measures
Wound infections
Wound infections after day 7 till 30 days following HPB surgery.
Surgical site complication
Surgical site complication (hematoma/seroma/wound dehiscence) within 30 days of HPB surgery.
Rate of fascial dehiscence
Rate of fascial dehiscence within 30 days of HPB surgery.
Antibiotic therapy
Need for antibiotic therapy for iSSI beyond perioperative/postoperative surgical prophylaxis.
Length of hospital stay.
Length of hospital stay.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05481398
Brief Title
A Randomized Controlled Trial Evaluating the Role of Negative Pressure Wound Therapy (NPWT) for Incisional Surgical Site Infections in Patients Undergoing Hepatopancreatobiliary Surgery
Acronym
NPWT
Official Title
Negative Pressure Wound Therapy (NPWT) for Incisional Surgical Site Infections in Patients Undergoing Hepatopancreatobiliary Surgery: A Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
March 6, 2021 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Murk Niaz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To compare the rates of incisional surgical site infections (iSSIs) within 7 days of hepatopancreatobiliary (HPB) surgery using negative pressure wound therapy (NWPT) versus using standard sterile gauze dressing.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatobiliary Disease, Hepatobiliary Disorders, Surgical Site Infection
Keywords
Hepatopancreatobiliary surgery, Surgical site infection, Negative pressure wound therapy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomization Patients will be randomly allocated into intervention group A (NPWT) or control group (B) by simple randomization.
Masking
Outcomes Assessor
Masking Description
Two individuals were assigned the role of outcome assessors to examine the wound after removal of the dressing and score the wound for infection using the ASEPSIS score.
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group A
Arm Type
Experimental
Arm Description
After the skin closed, negative pressure wound therapy will be applied.
Arm Title
Control group B
Arm Type
No Intervention
Arm Description
After the skin is closed, the wound is covered using sterile standard guaze dressing.
Intervention Type
Other
Intervention Name(s)
Negative Pressure Wound Therapy
Intervention Description
The wound is dressed using negative pressure wound therapy comprising of a single layer of sterile gauze followed by placement of a 18 Fr nelaton catheter and the wound further covered with 4 more layers of sterile gauze over the nelaton catheter. The wound is then covered with opsite dressing making it airtight. The nelaton catheter is attached to the wall suction port once the patient is shifted to the bed with pressure set at - 25 mm Hg.
Primary Outcome Measure Information:
Title
Rate of incisional surgical site infections (iSSIs)
Description
To compare the rates of incisional surgical site infections (iSSIs) within 7 days of hepatopancreatobiliary (HPB) surgery using negative pressure wound therapy (NWPT) versus using standard sterile gauze dressing.
Time Frame
within 7 days of hepatopancreatobiliary (HPB) surgery
Secondary Outcome Measure Information:
Title
Wound infections
Description
Wound infections after day 7 till 30 days following HPB surgery.
Time Frame
day 7 till 30 days following HPB surgery
Title
Surgical site complication
Description
Surgical site complication (hematoma/seroma/wound dehiscence) within 30 days of HPB surgery.
Time Frame
within 30 days of HPB surgery
Title
Rate of fascial dehiscence
Description
Rate of fascial dehiscence within 30 days of HPB surgery.
Time Frame
within 30 days of HPB surgery
Title
Antibiotic therapy
Description
Need for antibiotic therapy for iSSI beyond perioperative/postoperative surgical prophylaxis.
Time Frame
Day 1 to day 30
Title
Length of hospital stay.
Description
Length of hospital stay.
Time Frame
Day 1 to day 30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients undergoing elective open HPB surgery (benign or malignant disease) of age > 18 years consenting to the study protocol.
Exclusion Criteria:
The patient in which primary wound closure is not achieved. The patient planned for a second look surgery. The patient with the history of long-term antibiotic use (more than a month). Past history of open abdominal surgery (less than 1 month).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uzma Soomro
Organizational Affiliation
Sindh Institute of Urology and Transplantation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sindh Institute of Urology and Transplantation
City
Karachi
State/Province
Sindh
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Randomized Controlled Trial Evaluating the Role of Negative Pressure Wound Therapy (NPWT) for Incisional Surgical Site Infections in Patients Undergoing Hepatopancreatobiliary Surgery
We'll reach out to this number within 24 hrs