Closed Incision Negative Pressure Therapy Versus Standard of Care Surgical Dressing in Revision Total Knee Arthroplasty
NCT ID: NCT03274466
Last Updated: 2024-10-16
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
294 participants
INTERVENTIONAL
2017-12-05
2019-12-19
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison of Negative Pressure Wound Therapy vs. Conventional Dressings for Prevention of Wound Complications After Revision THA
NCT03321799
Evaluating Edema and Range of Motion Using Negative Pressure Therapy vs. Standard Surgical Dressing in Bilateral TKA
NCT04712019
Routine Use of Negative Pressure Wound Therapy THR TKR RCT
NCT06181097
Antimicrobial Barrier Dressing Versus Closed-incision Negative Pressure Therapy in the Obese Primary Total Joint Arthroplasty
NCT03345771
Evaluation of Wound Management With Negative Pressure Dressing Versus Standard Dressing After Revision Arthroplasty.
NCT02127281
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Closed Incision Negative Pressure Therapy (ciNPT)
Prevena Peel \& Place or Prevena Plus Customizable Dressing and ActiVAC Therapy Unit or Prevena Plus Therapy Unit
Closed Incision Negative Pressure Therapy (ciNPT)
Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric that includes 0.019% ionic silver at 125 mmHg of negative pressure for 5-7 days.
Standard of Care Dressing
Silver impregnated dressing
Standard of Care Dressing
A standard silver-impregnated dressing applied to a closed surgical incision for 5-7 days post-operatively.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Closed Incision Negative Pressure Therapy (ciNPT)
Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric that includes 0.019% ionic silver at 125 mmHg of negative pressure for 5-7 days.
Standard of Care Dressing
A standard silver-impregnated dressing applied to a closed surgical incision for 5-7 days post-operatively.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* is at least 22 years of age on the date of informed consent
* is able to provide their own informed consent
* requires a TKA revision defined as one of the following:
1. a one-stage aseptic revision procedure
2. a one-stage septic exchange procedure (requiring removal of all hardware) for acute postoperative infection
3. removal of cement spacer and re-implantation procedure
4. open reduction and internal fixation of peri-prosthetic fractures
* has one or more of the following:
1. a body mass index (BMI) greater than 35 kg/m2
2. a requirement for the use of blood thinners other than acetylsalicylic acid (ASA) after surgery
3. history of or current peripheral vascular disease
4. the presence of lymphedema in the operative limb
5. insulin-dependent diabetes mellitus
6. current tobacco use or previous history of smoking and quitting within the past 30 days
7. a history of prior infection of the operative site
8. current use of immunomodulators or steroids
9. current or history of cancer or hematological malignancy (excluding localized skin cancer)
10. rheumatoid arthritis
11. current renal failure or dialysis
12. malnutrition as determined by the investigator
13. liver disease as determined by the investigator
14. status post solid organ transplant
15. HIV
* is willing and able to return for all scheduled study visits
* if female, has a negative urine or serum pregnancy test at screening and day of revision surgery. Women who have had surgical sterilization by a medically accepted method such as tubal ligation, hysterectomy, or oophorectomy or are post-menopausal, defined as not having menstruation for \>= 12 months will be excluded from requiring this test.
The subject:
* has undergone a TKA revision resulting in a closed surgical incision
Exclusion Criteria
* is pregnant or lactating
* will undergo a bilateral TKA within the same operative visit
* will undergo a bilateral TKA in which the first TKA surgery is on the knee selected for study
* will undergo a staged bilateral TKA in which the TKA revision surgery for the knee under study occurs within 30 days of the first TKA procedure
* was previously randomized in this protocol
* has a systemic active infection at the time of revision not including chronic viral infections such as HIV or hepatitis
* has a remote-site skin infection at the time of revision
* was tattooed on the area of the incision within 30 days prior to randomization
* has known sensitivity to the study product components (drape and/or dressing materials in direct contact with the closed incision or skin)
* has known sensitivity to silver
* is currently enrolled in another investigational trial that requires additional interventions
* is planned to be enrolled in another investigational trial that requires additional interventions at any time during the study
* has localized skin cancer around the incision site
The subject:
* has a surgical incision that precludes placement of dressing
* has a TKA revision resulting in a muscle flap
* has a TKA revision resulting in the placement of a spacer
* has an incision drainage and debridement procedure only
* has a surgical incision closed with skin glue
22 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
3M
INDUSTRY
KCI USA, Inc
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Carlos Higuera, MD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cleveland Clinic
Weston, Florida, United States
Emory University Orthopedics & Spine Hospital
Tucker, Georgia, United States
LSU Health Science Center
New Orleans, Louisiana, United States
University of Missouri Health Care
Columbia, Missouri, United States
Northwell Health - SouthSide Hospital
Bay Shore, New York, United States
New York University (NYU)
New York, New York, United States
Hospital for Special Surgery
New York, New York, United States
Columbia University Medical Center/New York Presbyterian Hospital
New York, New York, United States
Northwell Health - Lenox Hill Hospital
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Joint Implant Surgeons
New Albany, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Rothman Institute - Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Houston Methodist Research Institute
Houston, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KCI.PREVENA.2017.01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.