Negative Pressure Wound Therapy to Reduce Surgical Site Infection

NCT01905397 | Completed Results DMC FDA Device

• 1 other identifier: Pro00045975
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 2

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.

Conditions

Patients Undergoing Hepatopancreatobiliary Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Surgical Site Infections by Type

  30 days post-surgery

• Length of Hospital Stay

  Up to 62 days post-surgery

Study Arms (2)

Negative Pressure Wound Therapy

ACTIVE COMPARATOR

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

Device: Negative pressure wound therapy

Conventional wound therapy

ACTIVE COMPARATOR

Traditional wound therapy (sterile bandages and dressing)

Device: Conventional wound therapy

Interventions

Conventional wound therapy DEVICE

Sterile bandages and wound coverings

Conventional wound therapy

Negative pressure wound therapy DEVICE

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.

Also known as: Prevena Incision Management System; ActiVAC

Negative Pressure Wound Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead
• Kinetic Concepts, Inc.: collaborator

Study Sites (2)

Indiana University

Indianapolis, Indiana, 46223, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• Ceppa EP, Kim RC, Niedzwiecki D, Lowe ME, Warren DA, House MG, Nakeeb A, Zani S, Moyer AN, Blazer DG 3rd; Closed Incision Negative Pressure Therapy (ciNPT) Investigators. Closed Incision Negative Pressure Therapy to Reduce Surgical Site Infection in High-Risk Gastrointestinal Surgery: A Randomized Controlled Trial. J Am Coll Surg. 2023 Apr 1;236(4):698-708. doi: 10.1097/XCS.0000000000000547. Epub 2023 Jan 10.

  PMID: 36728375 DERIVED

MeSH Terms

Interventions

Negative-Pressure Wound Therapy

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Results Point of Contact

• Title: Dan Blazer III, MD
• Organization: Duke University Medical Center

trey.blazer@duke.edu

919-668-1861

Study Officials

• Dan Blazer, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2013
• First Posted: July 23, 2013
• Study Start: December 18, 2013
• Primary Completion: May 26, 2021
• Study Completion: May 26, 2021
• Last Updated: December 2, 2022
• Results First Posted: October 10, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)