Closed Incision Negative Pressure Therapy Versus Standard of Care Surgical Dressing in Revision Total Knee Arthroplasty (PROMISES)
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| ClinicalTrials.gov Identifier: NCT03274466 |
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Recruitment Status :
Completed
First Posted : September 7, 2017
Results First Posted : February 10, 2021
Last Update Posted : February 10, 2021
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Sponsor:
KCI USA, Inc.
Information provided by (Responsible Party):
KCI USA, Inc.
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Surgical Wound Revision Total Knee Arthroplasty Wounds and Injuries Joint Disease Musculoskeletal Disease Prosthesis-Related Infections Infection Postoperative Complications Pathologic Processes | Device: Closed Incision Negative Pressure Therapy (ciNPT) Device: Standard of Care Dressing | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 294 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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) |
| Actual Study Start Date : | December 5, 2017 |
| Actual Primary Completion Date : | November 27, 2019 |
| Actual Study Completion Date : | December 19, 2019 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Knee Replacement
| Arm | Intervention/treatment |
|---|---|
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Experimental: Closed Incision Negative Pressure Therapy (ciNPT)
Prevena Peel & Place or Prevena Plus Customizable Dressing and ActiVAC Therapy Unit or Prevena Plus Therapy Unit
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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:
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Active Comparator: Standard of Care Dressing
Silver impregnated dressing
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Device: Standard of Care Dressing
A standard silver-impregnated dressing applied to a closed surgical incision for 5-7 days post-operatively.
Other Name: Silver-impregnated dressing, Aquacel Ag Surgical or other equivalent |
Primary Outcome Measures :
- Number of Participants With Surgical Site Complications (SSC) [ Time Frame: within 90 days after TKA revision ]
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
Secondary Outcome Measures :
- Number of Participants With Surgical Site Infection (SSI) (Superficial or Deep) [ Time Frame: 90 days after TKA revision ]90 day subject incidence of any SSI (superficial or deep)
- Number of Participants With Deep Surgical Site Infection [ Time Frame: 90 days after TKA revision ]90 day subject incidence of deep surgical site infection
Other Outcome Measures:
- Number of Participants With Surgical Site Complication (SSC) [ Time Frame: within 90 days after TKA revision ]
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
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| Ages Eligible for Study: | 22 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
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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
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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
- a history of prior infection of the operative site
- current use of immunomodulators or steroids
- current or history of cancer or hematological malignancy (excluding localized skin cancer)
- rheumatoid arthritis
- current renal failure or dialysis
- malnutrition as determined by the investigator
- liver disease as determined by the investigator
- status post solid organ transplant
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03274466
Locations
Show 17 study locations
Sponsors and Collaborators
KCI USA, Inc.
Investigators
| Principal Investigator: | Carlos Higuera, MD | The Cleveland Clinic |
Study Documents (Full-Text)
Documents provided by KCI USA, Inc.:
Documents provided by KCI USA, Inc.:
Statistical Analysis Plan [PDF] August 8, 2019
Study Protocol [PDF] October 6, 2018
| Responsible Party: | KCI USA, Inc. |
| ClinicalTrials.gov Identifier: | NCT03274466 |
| Other Study ID Numbers: |
KCI.PREVENA.2017.01 |
| First Posted: | September 7, 2017 Key Record Dates |
| Results First Posted: | February 10, 2021 |
| Last Update Posted: | February 10, 2021 |
| Last Verified: | January 2021 |
| 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 |
Additional relevant MeSH terms:
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Infections Communicable Diseases Prosthesis-Related Infections Joint Diseases Musculoskeletal Diseases Postoperative Complications Pathologic Processes |
Wounds and Injuries Surgical Wound Disease Attributes Carboxymethylcellulose Sodium Laxatives Gastrointestinal Agents |