Improvement in Wound Healing With Negative Pressure Wound Therapy for Postoperative Total Hip Arthroplasty

NCT02355691 | Terminated Results

• 1 other identifier: 14-1920
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

For the target population of adult patients following primary total hip arthroplasty, the randomized clinical trial will be used to evaluate the efficacy of the use of a mobile negative pressure wound therapy(NPWT) device compared to a standard absorptive dressing in the immediate postoperative period. We will apply two dressing types and evaluate the postoperative wounds with a wound scoring system (ASEPSIS) that incorporates multiple variables of wound infection risk.

Conditions

Complications; Arthroplasty, Infection or Inflammation; Wound Complication

Outcome Measures

Primary Outcomes (1)

• Mean Wound Healing Scores by the ASEPSIS Criteria

  A method of evaluating wounds for infection risk that incorporates multiple wound healing factors such as erythema, drainage, and dehiscence is the ASEPSIS (Additional treatment, presence of Serous discharge, Erythema, Purulent exudate, Separation of the deep tissue, Isolation of bacteria, and duration of inpatient Stay) wound scoring system. Originally developed and validated for cardiac surgery sternal wounds, ASEPSIS evaluates the wound for the severity of multiple factors linked with surgical site infection. This includes dehiscence, exudate/discharge, and erythema. The higher the score, the more likely a surgical site infection will be present. This score will give us a more diverse picture of postoperative wound healing and the influence of Negative Pressure Wound Therapy. Scores can range from 0 to 65, with most scores expected at the lower scale.

  (Single point evaluation)-2 weeks post surgery visit

Secondary Outcomes (1)

• Number of Participants With Infection

  (Single point evaluation)-6 weeks post surgery visit

Study Arms (2)

PREVENA Group

EXPERIMENTAL

Patients will be treated with the PREVENA negative pressure device following total hip arthroplasty. This dressing will be used for a period of seven days.

Device: PREVENA

Standard group

NO INTERVENTION

Patients will be treated with the standard absorptive dressing following total hip arthroplasty.

Interventions

PREVENA DEVICE

The device is a sealed negative pressure wound therapy tool. The device will be placed on the skin during surgery and left in place until their followup at 7 days.

Also known as: KCI PREVENA Incision Management system

PREVENA Group

Eligibility Criteria

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

You may qualify if:

• \- Adult patients undergoing primary total hip arthroplasty.

You may not qualify if:

• age less than 18 y/o
• Total hip arthroplasty for fracture
• Revision or conversion total hip arthroplasty
• inability to personally consent to participation due to cognitive impairment, intoxication or sedation
• multiple surgical procedures
• Patients taking immune modulating medication(prednisone, methotrexate, anakinra, etc.)
• skin hypersensitivity to acrylic adhesive or silver.
• Inability to care for dressing due to physical or mental incapacitation

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Kinetic Concepts, Inc.: collaborator

Study Sites (1)

UNC Orthopaedics

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

• PREVENA website

MeSH Terms

Conditions

Infections; Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Major Limitation-Study could not be completed due to the loss of research personnel early during the trial. We did not have the funding to provide for an additional personnel.

Results Point of Contact

• Title: Scott Eskildsen, MD
• Organization: UNC Orthopaedics

seskilds@unch.unc.edu

(919) 966-9166

Study Officials

• Daniel J Del Gaizo, MD

  UNC Orthopaedics

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: January 30, 2015
• First Posted: February 4, 2015
• Study Start: May 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: April 17, 2018
• Results First Posted: April 17, 2018

Record last verified: 2018-03

Locations

US (1)