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

Post-market, Randomized, Open-Label, Multicenter, Study to Evaluate the Effectiveness of Closed Incision Negative Pressure Therapy Versus Standard of Care Dressings in Reducing Surgical Site Complications in Subjects With Revision of a Failed Total Knee Arthroplasty (PROMISES)

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.

Study Overview

• Status: Completed
• Conditions: Pathologic Processes; Wounds and Injuries; Postoperative Complications; Surgical Wound; Infection; Musculoskeletal Disease; Prosthesis-Related Infections; Joint Disease; Revision Total Knee Arthroplasty
• Intervention / Treatment: Device: Closed Incision Negative Pressure Therapy (ciNPT); Device: Standard of Care Dressing

• Study Type: Interventional
• Enrollment (Actual): 294
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Weston, Florida, United States, 33331
      • Cleveland Clinic
  • Georgia
    • Tucker, Georgia, United States, 30084
      • Emory University Orthopedics & Spine Hospital
  • Louisiana
    • New Orleans, Louisiana, United States, 70006
      • LSU Health Science Center
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri Health Care
  • New York
    • Bay Shore, New York, United States, 11706
      • Northwell Health - Southside Hospital
    • New York, New York, United States, 10021
      • Hospital for Special Surgery
    • New York, New York, United States, 10032
      • Columbia University Medical Center/New York Presbyterian Hospital
    • New York, New York, United States, 10003
      • New York University (NYU)
    • New York, New York, United States, 10075
      • Northwell Health - Lenox Hill Hospital
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • New Albany, Ohio, United States, 43054
      • Joint Implant Surgeons
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Rothman Institute - Thomas Jefferson University Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist Research Institute
  • Virginia
    • Richmond, Virginia, United States, 32743
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Closed Incision Negative Pressure Therapy (ciNPT); Prevena Peel & Place or Prevena Plus Customizable Dressing and ActiVAC Therapy Unit or Prevena Plus Therapy Unit	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.; Other Names: Prevena Peel & Place; Prevena Plus Customizable; ActiV.A.C. Therapy Unit; Prevena Plus 125 Therapy Unit
Active Comparator: Standard of Care Dressing; Silver impregnated dressing	Device: Standard of Care Dressing; A standard silver-impregnated dressing applied to a closed surgical incision for 5-7 days post-operatively.; Other Names: Silver-impregnated dressing, Aquacel Ag Surgical or other equivalent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Number of Participants With Deep Surgical Site Infection	90 day subject incidence of deep surgical site infection	90 days after TKA revision

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: 3M
• Investigators: Principal Investigator: Carlos Higuera, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2017
• Primary Completion (Actual): November 27, 2019
• Study Completion (Actual): December 19, 2019

Study Registration Dates

• First Submitted: September 5, 2017
• First Submitted That Met QC Criteria: September 5, 2017
• First Posted (Actual): September 7, 2017

Study Record Updates

• Last Update Posted (Actual): August 1, 2022
• Last Update Submitted That Met QC Criteria: July 29, 2022
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Disease Attributes; Infections; Communicable Diseases; Wounds and Injuries; Joint Diseases; Surgical Wound; Postoperative Complications; Musculoskeletal Diseases; Prosthesis-Related Infections; Pathologic Processes; Gastrointestinal Agents; Laxatives; Carboxymethylcellulose Sodium
• Other Study ID Numbers: KCI.PREVENA.2017.01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No