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
About this trial
This is an interventional treatment trial for Complications; Arthroplasty, Infection or Inflammation
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
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
NCT ID
NCT02355691
First Posted
January 30, 2015
Last Updated
March 19, 2018
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Kinetic Concepts, Inc.
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
Learn more about this trial
Improvement in Wound Healing With Negative Pressure Wound Therapy for Postoperative Total Hip Arthroplasty
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