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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Complications; Arthroplasty, Infection or Inflammation Wound Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

PREVENA

Intervention Type DEVICE

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.

Standard group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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KCI PREVENA Incision Management system

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No