A Randomized Controlled Trial Evaluating the Role of Negative Pressure Wound Therapy (NPWT) for Incisional Surgical Site Infections in Patients Undergoing Hepatopancreatobiliary Surgery (NPWT)

Negative Pressure Wound Therapy (NPWT) for Incisional Surgical Site Infections in Patients Undergoing Hepatopancreatobiliary Surgery: A Randomized Controlled Trial.

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.

Study Overview

• Status: Completed
• Conditions: Surgical Site Infection; Hepatobiliary Disease; Hepatobiliary Disorders
• Intervention / Treatment: Other: Negative Pressure Wound Therapy

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan
      • Sindh Institute of urology and Transplantation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention group A; After the skin closed, negative pressure wound therapy will be applied.	Other: Negative Pressure Wound Therapy; 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.
NO_INTERVENTION: Control group B; After the skin is closed, the wound is covered using sterile standard guaze dressing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	within 7 days of hepatopancreatobiliary (HPB) surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound infections	Wound infections after day 7 till 30 days following HPB surgery.	day 7 till 30 days following HPB surgery
Surgical site complication	Surgical site complication (hematoma/seroma/wound dehiscence) within 30 days of HPB surgery.	within 30 days of HPB surgery
Rate of fascial dehiscence	Rate of fascial dehiscence within 30 days of HPB surgery.	within 30 days of HPB surgery
Antibiotic therapy	Need for antibiotic therapy for iSSI beyond perioperative/postoperative surgical prophylaxis.	Day 1 to day 30
Length of hospital stay.	Length of hospital stay.	Day 1 to day 30

Collaborators and Investigators

• Sponsor: Murk Niaz
• Investigators: Principal Investigator: Uzma Soomro, Sindh Institute of urology and Transplantation

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 6, 2021
• Primary Completion (ACTUAL): July 1, 2022
• Study Completion (ACTUAL): July 1, 2022

Study Registration Dates

• First Submitted: July 28, 2022
• First Submitted That Met QC Criteria: July 28, 2022
• First Posted (ACTUAL): August 1, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 1, 2022
• Last Update Submitted That Met QC Criteria: July 28, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Negative pressure wound therapy; Surgical site infection; Hepatopancreatobiliary surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Disease Attributes; Wound Infection; Liver Diseases; Infections; Communicable Diseases; Digestive System Diseases; Surgical Wound Infection
• Other Study ID Numbers: NPWT HPB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No