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

Sponsor

Murk Niaz (Other)

Overall Status

Completed

CT.gov ID

NCT05481398

Collaborator

(none)

Enrollment

Location

Arms

15.8

Actual Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatobiliary Disease Hepatobiliary Disorders Surgical Site Infection	Other: Negative Pressure Wound Therapy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

46 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Single (Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Mar 6, 2021

Actual Primary Completion Date :

Jul 1, 2022

Actual Study Completion Date :

Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group A After the skin closed, negative pressure wound therapy will be applied.	Other: 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.
No Intervention: Control group B After the skin is closed, the wound is covered using sterile standard guaze dressing.

Arm

Intervention/Treatment

Experimental: Intervention group A

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

Other: 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.

No Intervention: Control group B

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

Outcome Measures

Primary Outcome Measures

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

Wound infections [day 7 till 30 days following HPB surgery]
Wound infections after day 7 till 30 days following HPB surgery.
Surgical site complication [within 30 days of HPB surgery]
Surgical site complication (hematoma/seroma/wound dehiscence) within 30 days of HPB surgery.
Rate of fascial dehiscence [within 30 days of HPB surgery]
Rate of fascial 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.
Length of hospital stay. [Day 1 to day 30]
Length of hospital stay.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).