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

Primary Purpose

Complications; Arthroplasty, Infection or Inflammation, Wound Complication

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PREVENA
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complications; Arthroplasty, Infection or Inflammation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UNC Orthopaedics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PREVENA Group

Standard group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
January 30, 2015
Last Updated
March 19, 2018
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Kinetic Concepts, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02355691
Brief Title
Improvement in Wound Healing With Negative Pressure Wound Therapy for Postoperative Total Hip Arthroplasty
Official Title
Improvement in Wound Healing With Negative Pressure Wound Therapy for Postoperative Total Hip Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Terminated
Why Stopped
Loss of Personnel
Study Start Date
May 2015 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Kinetic Concepts, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complications; Arthroplasty, Infection or Inflammation, Wound Complication

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PREVENA Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard group
Arm Type
No Intervention
Arm Description
Patients will be treated with the standard absorptive dressing following total hip arthroplasty.
Intervention Type
Device
Intervention Name(s)
PREVENA
Other Intervention Name(s)
KCI PREVENA Incision Management system
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean Wound Healing Scores by the ASEPSIS Criteria
Description
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.
Time Frame
(Single point evaluation)-2 weeks post surgery visit
Secondary Outcome Measure Information:
Title
Number of Participants With Infection
Description
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
Time Frame
(Single point evaluation)-6 weeks post surgery visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel J Del Gaizo, MD
Organizational Affiliation
UNC Orthopaedics
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNC Orthopaedics
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.kci1.com/KCI1/prevena
Description
PREVENA website

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

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