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

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.

Study Overview

• Status: Terminated
• Conditions: Complications; Arthroplasty, Infection or Inflammation; Wound Complication
• Intervention / Treatment: Device: PREVENA

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC Orthopaedics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- Adult patients undergoing primary total hip arthroplasty.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PREVENA Group; 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; 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.; Other Names: KCI PREVENA Incision Management system
No Intervention: Standard group; Patients will be treated with the standard absorptive dressing following total hip arthroplasty.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Infection	The investigators will continue to monitor the patients for development of an acute postoperative infection. A deep infection refers to an infection below the superficial soft tissue and likely involving the prosthesis. This will be evaluated by the musculoskeletal infection society consensus on total joint infection. Criteria include:(Either one major criteria or four minor criteria) Major criteria Sinus track communicating with the prosthesis Two separate cultures from the joint positive for the same organism Minor criteria Elevated erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) Elevated synovial leukocyte count Elevated synovial neutrophil percentage Purulent drainage from the joint One positive fluid culture from the joint Histological analysis of tissue showing more than 5 neutrophils per high power field in 5 fields	(Single point evaluation)-6 weeks post surgery visit

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Kinetic Concepts, Inc.
• Investigators: Principal Investigator: Daniel J Del Gaizo, MD, UNC Orthopaedics

Publications and helpful links

Helpful Links

• PREVENA website

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: January 30, 2015
• First Submitted That Met QC Criteria: January 30, 2015
• First Posted (Estimate): February 4, 2015

Study Record Updates

• Last Update Posted (Actual): April 17, 2018
• Last Update Submitted That Met QC Criteria: March 19, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Wounds and Injuries
• Other Study ID Numbers: 14-1920

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No