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

Wound Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02355691
• Other study ID #: 14-1920
• Status: Terminated
• Phase: N/A
• First received: January 30, 2015
• Last updated: March 19, 2018
• Start date: May 2015
• Est. completion date: May 2017

Study information

• Verified date: March 2018
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Complications; Arthroplasty, Infection or Inflammation
• Inflammation
• Wound Complication
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	UNC Orthopaedics	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Kinetic Concepts, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   PREVENA website