Negative Pressure Wound Therapy to Reduce Surgical Site Infection

Not Applicable

Completed

• Conditions: Patients Undergoing Hepatopancreatobiliary Surgery
• Interventions: Device: Negative pressure wound therapy; Device: Conventional wound therapy

• Registration Number: NCT01905397
• Lead Sponsor: Duke University

Brief Summary

The purpose of this study is to compare the rate of surgical site infection between traditional wound care and negative pressure wound therapy. Wounds will be assessed 4-5 days after surgery and at the first clinic visit after surgery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-18
• Study First Submitted QC: 2013-07-18
• Study First Posted: 2013-07-23
• Study Start: 2013-12-18
• Primary Completion: 2021-05-26
• Study Completion: 2021-05-26
• Results First Submitted: 2022-05-26
• Results First Submitted QC: 2022-10-06
• Results First Posted: 2022-10-10
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-30
• Last Update Posted: 2022-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

• Female and male patients 18 years of age or older
• Scheduled for an elective surgery in either open CRS or open HPBS. This includes, but is not limited to: ileocecectomy, right hemicolectomy, extended right hemicolectomy, transverse colectomy, left hemicolectomy, sigmoidectomy, proctectomy, low anterior resection, or abdominoperineal resection gastrectomy, hepatectomy, bile duct reconstruction, duodenectomy, pancreatectomy, pancreaticoduodenectomy, or pancreatic duct reconstruction

Read More

Exclusion Criteria

• The need for emergency surgery.
• The need for use of only laparoscopic surgery.
• Presence of bowel obstruction, strangulation, peritonitis or perforation.
• The presence of local or systemic infection preoperatively.
• ASA class ≥4.
• Inability to provide informed consent and authorization.
• Known allergy or hypersensitivity to silver.
• Any clinically significant condition that, in the investigator's opinion, would significantly impair the subject's ability to comply with the study.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Negative Pressure Wound Therapy	Negative pressure wound therapy	The Prevena Incision Management System is a 510K cleared device that covers and protects the incision from external infectious sources, while negative pressure removes fluid and infectious material from the surgical incision. The ActiVAC pump (also 510K cleared) may be used in some cases with the Prevena dressings as to achieve the negative pressure
Conventional wound therapy	Conventional wound therapy	Traditional wound therapy (sterile bandages and dressing)

Primary Outcome Measures

Name	Time	Method
Participants With a Surgical Site Infection	30 days after surgery; assessed at 4-5 days and 30 days post-operation	Number and percentage of participants with at least 1 surgical site infection (SSI).

Secondary Outcome Measures

Name	Time	Method
Number of Surgical Site Infections by Type	30 days post-surgery	Each surgical site infection was classified into one of the following categories: superficial incisional, deep incisional, or organ/space (as defined by The American College of Surgeons NSQIP \[National Surgical Quality Improvement Program\] guidelines). The number of infections in each category is reported separately for both treatment arms. Some participants had multiple infections.
Length of Hospital Stay	Up to 62 days post-surgery	Assess (or compare) the length of hospital stay between subjects who receive standard of care and incisional V.A.C. via PIMS.

Trial Locations

Locations (2)

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States