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

NCT05481398 | Completed

• 1 other identifier: NPWT HPB
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatobiliary Disease; Hepatobiliary Disorders; Surgical Site Infection

Keywords

Hepatopancreatobiliary surgery; Surgical site infection; Negative pressure wound therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Wound infections

  day 7 till 30 days following HPB surgery

• Surgical site complication

  within 30 days of HPB surgery

• Rate of fascial dehiscence

  within 30 days of HPB surgery

• Antibiotic therapy

  Day 1 to day 30

• Length of hospital stay.

  Day 1 to day 30

Study Arms (2)

Intervention group A

EXPERIMENTAL

After the skin closed, negative pressure wound therapy will be applied.

Other: Negative Pressure Wound Therapy

Control group B

NO INTERVENTION

After the skin is closed, the wound is covered using sterile standard guaze dressing.

Interventions

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.

Intervention group A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients undergoing elective open HPB surgery (benign or malignant disease) of age \> 18 years consenting to the study protocol.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Murk Niaz: lead

Study Sites (1)

Sindh Institute of Urology and Transplantation

Karachi, Sindh, Pakistan

Location

MeSH Terms

Conditions

Digestive System Diseases; Surgical Wound Infection

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Study Officials

• Uzma Soomro

  Sindh Institute of Urology and Transplantation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: General Surgery Resident

Model Details: Randomization Patients will be randomly allocated into intervention group A (NPWT) or control group (B) by simple randomization.

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 1, 2022
• Study Start: March 6, 2021
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: August 1, 2022

Record last verified: 2022-07

Locations

PA (1)