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

Not Applicable

Completed

• Conditions: Hepatobiliary Disorders; Surgical Site Infection; Hepatobiliary Disease
• Interventions: Other: Negative Pressure Wound Therapy

• Registration Number: NCT05481398
• Lead Sponsor: Murk Niaz

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-06
• Status Verified: 2022-07
• Primary Completion: 2022-07-01
• Study Completion: 2022-07-01
• Study First Submitted: 2022-07-28
• Study First Submitted QC: 2022-07-28
• Last Update Submitted: 2022-07-28
• Study First Posted: 2022-08-01
• Last Update Posted: 2022-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group A	Negative Pressure Wound Therapy	After the skin closed, negative pressure wound therapy will be applied.

Primary Outcome Measures

Name	Time	Method
Rate of incisional surgical site infections (iSSIs)	within 7 days of hepatopancreatobiliary (HPB) surgery	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

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

Trial Locations

Locations (1)

Sindh Institute of Urology and Transplantation; 🇵🇰 Karachi, Sindh, Pakistan