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NCT Number: NCT05481398

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

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Key information

Conditions

Hepatobiliary Disease Digestive System Diseases Hepatobiliary Disorders Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Site Infection Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sindh Institute of Urology and Transplantation

Karachi, Sindh, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Negative Pressure Wound Therapy

Other

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 outcomes

  1. Rate of incisional surgical site infections (iSSIs)

    Time frame: 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 outcomes

  1. Wound infections

    Time frame: day 7 till 30 days following HPB surgery

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

  2. Surgical site complication

    Time frame: within 30 days of HPB surgery

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

  3. Rate of fascial dehiscence

    Time frame: within 30 days of HPB surgery

    Rate of fascial dehiscence within 30 days of HPB surgery.

  4. Antibiotic therapy

    Time frame: Day 1 to day 30

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

  5. Length of hospital stay.

    Time frame: Day 1 to day 30

    Length of hospital stay.

Sponsors and collaborators

Lead sponsor

Murk Niaz

Other

Registry information

Official study title

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

Acronym: NPWT

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 1, 2022
Registry last updated
Aug 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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