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

Postoperative Complications Clinical Trial

— PROMISES  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03274466
• Other study ID #: KCI.PREVENA.2017.01
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

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

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