Evaluation of Wound Management With Negative Pressure Dressing Versus Standard Dressing After Revision Arthroplasty.

Study Results

Results available

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

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2017-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine the efficacy of a negative pressure wound therapy (NPWT) system after revision total knee and hip arthroplasty in patients at high risk for infection. It is hypothesized that the use of NPWT system (i.e., Prevena) in high risk patients prevents wound complications and decreases reoperation rates.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT02355691

Complications; Arthroplasty, Infection or Inflammation Wound Complication

TERMINATED NA

Evaluating Advantages of Prevena After Hip and Knee Arthroplasty

NCT01854138

Infection of Total Hip Joint Prosthesis

COMPLETED NA

Closed Incision Negative Pressure Therapy vs Standard of Care

NCT03061903

Wound Complication

COMPLETED NA

Closed Incision Negative Pressure Therapy Versus Standard of Care Surgical Dressing in Revision Total Knee Arthroplasty

NCT03274466

Surgical Wound Revision Total Knee Arthroplasty Wounds and Injuries +6 more

COMPLETED NA

Comparison of Negative Pressure Wound Therapy vs. Conventional Dressings for Prevention of Wound Complications After Revision THA

NCT03321799

Infection, Drainage

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

One of the primary causes of un-planned readmission following lower extremity arthroplasty procedures is infection. Continuous wound drainage poses a serious risk for infection and is often initially treated with absorbent dressings and/or oral antibiotics. Comorbidities such as obesity, diabetes and tobacco abuse predisposes to wound complications and therefore infection after these procedures. NPWT has proven to be effective for postoperative drainage and decreases the risk for infection or further reoperation. This prospective randomized trial will involve 160 patients at high risk for infection undergoing revision total knee or hip arthroplasty; 80 patients will be randomly selected to be treated with the NPWT system (Prevena) and randomly selected to be treated with the current standard of care wound dressing (control group). Patients will be enrolled at a single site of the Cleveland Clinic Health System (Main Campus).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prosthesis-related Infections Wound Complications Joint Diseases Musculoskeletal Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Prevena

Prevena NPWT system will be used immediately following surgery and continue postoperatively until hospital discharge (expected average of 4 days).

Group Type ACTIVE_COMPARATOR

Prevena

Intervention Type DEVICE

Device will be applied at end of procedure over closed incision.

Control

A standard of care sterile wound dressing will be placed.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Prevena

Device will be applied at end of procedure over closed incision.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Scheduled revision Total Hip or Knee Arthroplasty Procedure
* Presence of one of the following: body mass index (BMI) greater than 35, use of blood thinners other than acetylsalicylic acid (ASA) after surgery, peripheral vascular disease, depression, diabetes mellitus, current tobacco use, history of prior infection, current use of immunomodulators or steroids, current history of cancer or hematological malignancy, rheumatoid arthritis, renal failure or dialysis, malnutrition, liver disease, transplant status, or HIV.