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

NCT03274466 | Completed Results FDA Device

• 1 other identifier: KCI.PREVENA.2017.01
• Study Type: interventional
• Target: 294
• Locations: 1 country
• Sites: 17

Brief 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.

Conditions

Surgical Wound; Revision Total Knee Arthroplasty; Wounds and Injuries; Joint Disease; Musculoskeletal Disease; Prosthesis-Related Infections; Infection; Postoperative Complications; Pathologic Processes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Participants With Surgical Site Infection (SSI) (Superficial or Deep)

  90 days after TKA revision

• Number of Participants With Deep Surgical Site Infection

  90 days after TKA revision

Other Outcomes (1)

• Number of Participants With Surgical Site Complication (SSC)

  within 90 days after TKA revision

Study Arms (2)

Closed Incision Negative Pressure Therapy (ciNPT)

EXPERIMENTAL

Prevena Peel \& Place or Prevena Plus Customizable Dressing and ActiVAC Therapy Unit or Prevena Plus Therapy Unit

Device: Closed Incision Negative Pressure Therapy (ciNPT)

Standard of Care Dressing

ACTIVE COMPARATOR

Silver impregnated dressing

Device: Standard of Care Dressing

Interventions

Closed Incision Negative Pressure Therapy (ciNPT) DEVICE

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.

Also known as: Prevena Peel & Place, Prevena Plus Customizable, ActiV.A.C. Therapy Unit, Prevena Plus 125 Therapy Unit

Closed Incision Negative Pressure Therapy (ciNPT)

Standard of Care Dressing DEVICE

A standard silver-impregnated dressing applied to a closed surgical incision for 5-7 days post-operatively.

Also known as: Silver-impregnated dressing, Aquacel Ag Surgical or other equivalent

Standard of Care Dressing

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• a one-stage aseptic revision procedure
• a one-stage septic exchange procedure (requiring removal of all hardware) for acute postoperative infection
• removal of cement spacer and re-implantation procedure
• open reduction and internal fixation of peri-prosthetic fractures
• has one or more of the following:
• a body mass index (BMI) greater than 35 kg/m2
• a requirement for the use of blood thinners other than acetylsalicylic acid (ASA) after surgery
• history of or current peripheral vascular disease
• the presence of lymphedema in the operative limb
• insulin-dependent diabetes mellitus
• current tobacco use or previous history of smoking and quitting within the past 30 days

You may not qualify if:

• 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
• The subject:

Sponsors & Collaborators

• KCI USA, Inc: lead
• 3M: collaborator

Study Sites (17)

Cleveland Clinic

Weston, Florida, 33331, United States

Location

Emory University Orthopedics & Spine Hospital

Tucker, Georgia, 30084, United States

Location

LSU Health Science Center

New Orleans, Louisiana, 70006, United States

Location

University of Missouri Health Care

Columbia, Missouri, 65212, United States

Location

Northwell Health - SouthSide Hospital

Bay Shore, New York, 11706, United States

Location

New York University (NYU)

New York, New York, 10003, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Columbia University Medical Center/New York Presbyterian Hospital

New York, New York, 10032, United States

Location

Northwell Health - Lenox Hill Hospital

New York, New York, 10075, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Joint Implant Surgeons

New Albany, Ohio, 43054, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Rothman Institute - Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Houston Methodist Research Institute

Houston, Texas, 77030, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 32743, United States

Location

MeSH Terms

Conditions

Surgical Wound; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Prosthesis-Related Infections; Infections; Postoperative Complications; Pathologic Processes

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Director of Clinical Research
• Organization: KCI | 3M

actate@mmm.com

(210) 515-4060

Study Officials

• Carlos Higuera, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2017
• First Posted: September 7, 2017
• Study Start: December 5, 2017
• Primary Completion: November 27, 2019
• Study Completion: December 19, 2019
• Last Updated: October 16, 2024
• Results First Posted: February 10, 2021

Record last verified: 2024-10

Locations

US (17)