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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-06

Study Completion Date

2022-07-01

Brief Summary

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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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Detailed Description

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Conditions

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Hepatobiliary Disease Hepatobiliary Disorders Surgical Site Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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Intervention group A

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

Group Type EXPERIMENTAL

Negative Pressure Wound Therapy

Intervention Type 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.

Control group B

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No