Negative Pressure Wound Therapy for Prevention of Poststernotomy Infection

NCT02020018 | Completed Results

• 1 other identifier: 16-007901
• Study Type: interventional
• Target: 1,869
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective study evaluates the role of negative pressure wound therapy or wound VAC as a dressing over the incision to prevent poststernotomy wound infection in high risk patients.

Conditions

Surgical Wound Infection

Outcome Measures

Primary Outcomes (1)

• Wound Infection After Open Heart Surgery

  The total number of participants with surgical site infections after cardiac surgery.

  30 days post-surgery

Secondary Outcomes (1)

• Reoperation for Wound Infection

  30 days post surgery

Other Outcomes (1)

• Length of Stay

  postoperative to discharge

Study Arms (2)

Prospective group

EXPERIMENTAL

Negative pressure wound therapy (Prevena Incision Management System) applied immediately postoperatively.

Device: Prevena Incision Management System

Retrospective arm

ACTIVE COMPARATOR

Conventional sterile dry wound dressing applied immediately postoperatively.

Other: Conventional sterile dry wound dressing

Interventions

Prevena Incision Management System DEVICE

negative pressure therapy that will be applied instead of the regular dressing immediately postoperatively in high risk patients and kept for 6-7 days

Also known as: negative pressure therapy, wound VAC, Prevena

Prospective group

Conventional sterile dry wound dressing OTHER

regular dressing that is applied immediately postoperatively for high risk patients in the operating room after sternotomy

Also known as: poststernotomy wound dressing, standard dressing after sternotomy

Retrospective arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Transplant patients
• BMI \>30
• Type I (insulin-dependent) diabetics
• Severe chronic obstructive pulmonary disease (COPD)
• Steroid-dependent patients
• Previous Tracheostomy

You may not qualify if:

• BMI\<30
• Thoracotomy

Sponsors & Collaborators

• Mayo Clinic: lead
• KCI USA, Inc: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Hartzell V. Schaff
• Organization: Mayo Clinic

schaff.hartzell@mayo.edu

507-255-7066

Study Officials

• Hartzell V Schaff, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: December 18, 2013
• First Posted: December 24, 2013
• Study Start: October 1, 2013
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: November 6, 2019
• Results First Posted: November 6, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)