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

Surgical Site Infection Clinical Trial

— NPWT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05481398
• Other study ID #: NPWT HPB
• Status: Completed
• Phase: N/A
• Start date: March 6, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: July 2022
• Source: Sindh Institute of Urology and Transplantation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Communicable Diseases
• Digestive System Diseases
• Hepatobiliary Disease
• Hepatobiliary Disorders
• Infections
• Liver Diseases
• Surgical Site Infection
• Surgical Wound Infection

Intervention

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.

Locations

Country	Name	City	State
Pakistan	Sindh Institute of Urology and Transplantation	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Murk Niaz

Country where clinical trial is conducted

Pakistan, 

Outcome

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