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

Murk Niaz46 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Hepatobiliary Disease Hepatobiliary Disorders Surgical Site Infection

Interventions

Negative Pressure Wound TherapyOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

Sindh Institute of Urology and Transplantation

Karachi, Sindh, Pakistan

Outcomes

Primary Outcomes

Rate of incisional surgical site infections (iSSIs)

Time frame: within 7 days of hepatopancreatobiliary (HPB) surgery

Secondary Outcomes

Wound infections

Wound infections after day 7 till 30 days following HPB surgery.

Time frame: day 7 till 30 days following HPB surgery

Surgical site complication

Surgical site complication (hematoma/seroma/wound dehiscence) within 30 days of HPB surgery.

Time frame: within 30 days of HPB surgery

Rate of fascial dehiscence

Rate of fascial dehiscence within 30 days of HPB surgery.

Time frame: within 30 days of HPB surgery

Antibiotic therapy

Need for antibiotic therapy for iSSI beyond perioperative/postoperative surgical prophylaxis.

Time frame: Day 1 to day 30

Length of hospital stay.

Time frame: Day 1 to day 30

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.