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

Study Overview
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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.

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

Conditions
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Hepatobiliary Disease, Hepatobiliary Disorders, Surgical Site Infection

Intervention / Treatment
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* Other: Negative Pressure Wound Therapy


Participation Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomization Patients will be randomly allocated into intervention group A (NPWT) or control group (B) by simple randomization.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group A<br>After the skin closed, negative pressure wound therapy will be applied. | Other: Negative Pressure Wound Therapy<br>* 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.<br>|
| No Intervention: Control group B<br>After the skin is closed, the wound is covered using sterile standard guaze dressing. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatopancreatobiliary surgery, Surgical site infection, Negative pressure wound therapy