Evaluation of Wound Management With Negative Pressure Dressing Versus Standard Dressing After Revision Arthroplasty.
Status: | Completed |
---|---|
Conditions: | Hospital, Orthopedic, Orthopedic |
Therapuetic Areas: | Orthopedics / Podiatry, Other |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 9/21/2018 |
Start Date: | May 2014 |
End Date: | June 30, 2017 |
Randomized Controlled Trial of Wound Management With Negative Pressure Dressing Versus Standard Dressing After Knee and Hip Revision Arthroplasty.
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.
(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.
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).
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).
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.
Exclusion Criteria:
- Patient lives >100 miles from hospital
- Patient is < 18 years old
- Silver allergy
We found this trial at
1
site
9500 Euclid Avenue
Cleveland, Ohio 44106
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Carlos Higuera-Rueda, MD
Phone: 216-444-4954
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