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

University of North Carolina (UNC)

Status: Terminated

Conditions: Wound Complication; Complications; Arthroplasty, Infection or Inflammation

Treatments: Device: PREVENA

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02355691

14-1920

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

PREVENA Group

Experimental group

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.

Treatment:

Device: PREVENA

Standard group

No Intervention group

Description:

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