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

Musculoskeletal Diseases Clinical Trial

Official title:

Randomized Controlled Trial of Wound Management With Negative Pressure Dressing Versus Standard Dressing After Knee and Hip Revision Arthroplasty.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02127281
• Other study ID #: CCF 14-273
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: June 30, 2017

Study information

• Verified date: August 2018
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: June 30, 2017
• Est. primary completion date: April 24, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Joint Diseases
• Musculoskeletal Diseases
• Prosthesis-related Infections
• Wound Complications
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	KCI USA, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

Bozic KJ, Kurtz SM, Lau E, Ong K, Chiu V, Vail TP, Rubash HE, Berry DJ. The epidemiology of revision total knee arthroplasty in the United States. Clin Orthop Relat Res. 2010 Jan;468(1):45-51. doi: 10.1007/s11999-009-0945-0. Epub 2009 Jun 25. — View Citation

Hansen E, Durinka JB, Costanzo JA, Austin MS, Deirmengian GK. Negative pressure wound therapy is associated with resolution of incisional drainage in most wounds after hip arthroplasty. Clin Orthop Relat Res. 2013 Oct;471(10):3230-6. doi: 10.1007/s11999-013-2937-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Wound Complications	Any wound complications including but not limited to drainage, blisters, cellulitis, superficial infection, and deep infection.	Within 90 days after surgery
Primary	Re-operation Rates	Number of patients who required re-operations that were related to the revision arthroplasty and occurred within 90 days of the revision	Within 90 days after surgery
Primary	Readmission Rates	Number of patients who had hospital readmission(s) related to the revision surgery that occurred within 90 days of revision	Within 90 days after surgery
Secondary	Knee Flexion	Mean knee flexion (degrees) at 4 weeks postoperatively	4 weeks postoperative
Secondary	HOOS and KOOS Scores at 90 Days Postoperatively	Mean Hip Osteoarthritis Outcome Score (HOOS), Knee Osteoarthritis Outcomes Score (KOOS) at 90 days postoperatively. Presented as subscores, including activities of daily living (ADL), pain, quality of life (QOL), symptoms, sports and recreation. All subscores range from 0-100, with 0 being the worst score and 100 being the best possible score.	90 days postoperative
Secondary	Timed-up-and-go Test	Median Timed-up-and-go test (seconds)	4 weeks postoperatively
Secondary	Hip Range of Motion (Flexion)	Mean hip range of motion (flexion, in degrees) at 4 weeks postoperatively	4 weeks postoperative
Secondary	VR-12 Questionnaire	Mean VR-12 scores, presented as 2 composite scores physical component summary (PCS) and mental component summary (MCS). Physical Component Score (PCS): Provides greater emphasis on questions about general health, physical functioning and role playing and bodily pain. Mental Component Score (MCS): Provides greater emphasis on questions about role-emotional, vitality/mental health and social functioning. PCS and MCS summary scores are standardized using a z-score transformation and normed to a U.S. population (based on a 1990 norm) of a score of 50 and a standard deviation of 10. Higher MCS and PCS scores reflect better overall physical and mental health, respectively.	90 days postoperatively
Secondary	Hip Range of Motion	Median hip range of motion (extension, in degrees) at 4 weeks postoperatively	4 weeks postoperative
Secondary	Knee Extension	Median knee extension (degrees) at 4 weeks postoperatively	4 weeks postoperative