Negative Pressure Wound Therapy to Reduce Surgical Site Infection

Patients Undergoing Hepatopancreatobiliary Surgery Clinical Trial

Official title:

Evaluation of Negative Pressure Wound Therapy for Reduction of Postoperative Surgical Site Infection in Patients Undergoing Colorectal and Hepatopancreatobiliary Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01905397
• Other study ID #: Pro00045975
• Status: Completed
• Phase: N/A
• Start date: December 18, 2013
• Est. completion date: May 26, 2021

Study information

• Verified date: November 2022
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: May 26, 2021
• Est. primary completion date: May 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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.

Related Conditions & MeSH terms

• Patients Undergoing Hepatopancreatobiliary Surgery
• Surgical Wound Infection

Intervention

Device:
• Conventional wound therapy
Sterile bandages and wound coverings
• Negative pressure wound therapy
The Prevena Incision Management System covers and protects the incision from external infectious sources, while negative pressure removes fluid and infectious material from the surgical incision. The ActiVAC pump may be used with the Prevena dressings as well in some situations to achieve negative pressure.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina
United States	Indiana University	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Kinetic Concepts, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants With a Surgical Site Infection	Number and percentage of participants with at least 1 surgical site infection (SSI).	30 days after surgery; assessed at 4-5 days and 30 days post-operation
Secondary	Number of Surgical Site Infections by Type	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.	30 days post-surgery
Secondary	Length of Hospital Stay	Assess (or compare) the length of hospital stay between subjects who receive standard of care and incisional V.A.C. via PIMS.	Up to 62 days post-surgery