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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03274466
Other study ID # KCI.PREVENA.2017.01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 5, 2017
Est. completion date December 19, 2019

Study information

Verified date January 2021
Source 3M
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study evaluates surgical site complications in subjects undergoing revision of a total knee arthroplasty when closed incision negative pressure therapy is used to manage the closed incision, as compared to a standard of care dressing.


Recruitment information / eligibility

Status Completed
Enrollment 294
Est. completion date December 19, 2019
Est. primary completion date November 27, 2019
Accepts healthy volunteers No
Gender All
Age group 22 Years and older
Eligibility Pre-operative Inclusion Criteria: The subject: - 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. Intra-operative Inclusion Criteria: The subject: - continues to meet all pre-operative inclusion criteria - has undergone a TKA revision resulting in a closed surgical incision Pre-operative Exclusion Criteria: The subject: - 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 Intra-operative Exclusion Criteria: The subject: - is found to meet any of the pre-operative exclusion criteria - 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

Study Design


Intervention

Device:
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.

Locations

Country Name City State
United States Northwell Health - SouthSide Hospital Bay Shore New York
United States Cleveland Clinic Cleveland Ohio
United States University of Missouri Health Care Columbia Missouri
United States Duke University Medical Center Durham North Carolina
United States Houston Methodist Research Institute Houston Texas
United States Joint Implant Surgeons New Albany Ohio
United States LSU Health Science Center New Orleans Louisiana
United States Columbia University Medical Center/New York Presbyterian Hospital New York New York
United States Hospital for Special Surgery New York New York
United States New York University (NYU) New York New York
United States Northwell Health - Lenox Hill Hospital New York New York
United States Rothman Institute - Thomas Jefferson University Hospital Philadelphia Pennsylvania
United States University of Pennsylvania Philadelphia Pennsylvania
United States Oregon Health & Science University Portland Oregon
United States Virginia Commonwealth University Richmond Virginia
United States Emory University Orthopedics & Spine Hospital Tucker Georgia
United States Cleveland Clinic Weston Florida

Sponsors (1)

Lead Sponsor Collaborator
3M

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Number of Participants With Surgical Site Complication (SSC) The subject incidence of Investigator-assessed surgical site complications (SSCs) within 90 days of TKA revision. SSCs include any of the the following:
Superficial Surgical Site Infection (SSI)
Deep SSI
Full thickness skin dehiscence
Seroma or hematoma requiring drainage or surgery
within 90 days after TKA revision
Primary Number of Participants With Surgical Site Complications (SSC) The subject incidence of Investigator-assessed surgical site complications (SSCs) within 90 days of TKA revision. SSCs include any of the following:
Superficial Surgical Site Infection (SSI)
Deep SSI
Full thickness skin dehiscence
Seroma or hematoma requiring drainage or surgery
Skin necrosis
Continued drainage at the time of dressing removal
within 90 days after TKA revision
Secondary Number of Participants With Surgical Site Infection (SSI) (Superficial or Deep) 90 day subject incidence of any SSI (superficial or deep) 90 days after TKA revision
Secondary Number of Participants With Deep Surgical Site Infection 90 day subject incidence of deep surgical site infection 90 days after TKA revision
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