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| Name | Class |
|---|---|
| 3M | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Closed Incision Negative Pressure Therapy (ciNPT) | Experimental | Prevena Peel & Place or Prevena Plus Customizable Dressing and ActiVAC Therapy Unit or Prevena Plus Therapy Unit |
|
| Standard of Care Dressing | Active Comparator | Silver impregnated dressing |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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:
| within 90 days after TKA revision |
| 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 |
| 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:
| within 90 days after TKA revision |
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:
has one or more of the following:
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:
Pre-operative Exclusion Criteria:
The subject:
Intra-operative Exclusion Criteria:
The subject:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos Higuera, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Weston | Florida | 33331 | United States | ||
| Emory University Orthopedics & Spine Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Closed Incision Negative Pressure Therapy (ciNPT) | Prevena Peel & Place or Prevena Plus Customizable Dressing and ActiVAC Therapy Unit or Prevena Plus Therapy Unit 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 6, 2018 | Sep 2, 2020 |
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|
| Standard of Care Dressing | Device | A standard silver-impregnated dressing applied to a closed surgical incision for 5-7 days post-operatively. |
|
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90 day subject incidence of deep surgical site infection
| 90 days after TKA revision |
| Tucker |
| Georgia |
| 30084 |
| United States |
| LSU Health Science Center | New Orleans | Louisiana | 70006 | United States |
| University of Missouri Health Care | Columbia | Missouri | 65212 | United States |
| Northwell Health - SouthSide Hospital | Bay Shore | New York | 11706 | United States |
| New York University (NYU) | New York | New York | 10003 | United States |
| Hospital for Special Surgery | New York | New York | 10021 | United States |
| Columbia University Medical Center/New York Presbyterian Hospital | New York | New York | 10032 | United States |
| Northwell Health - Lenox Hill Hospital | New York | New York | 10075 | United States |
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Joint Implant Surgeons | New Albany | Ohio | 43054 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Rothman Institute - Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Houston Methodist Research Institute | Houston | Texas | 77030 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 32743 | United States |
| FG001 | Standard of Care Dressing | Silver impregnated dressing Standard of Care Dressing: A standard silver-impregnated dressing applied to a closed surgical incision for 5-7 days post-operatively. |
| COMPLETED |
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| NOT COMPLETED |
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Randomized Subjects (ITT)
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| ID | Title | Description |
|---|---|---|
| BG000 | Closed Incision Negative Pressure Therapy (ciNPT) | Prevena Peel & Place or Prevena Plus Customizable Dressing and ActiVAC Therapy Unit or Prevena Plus Therapy Unit 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. |
| BG001 | Standard of Care Dressing | Silver impregnated dressing Standard of Care Dressing: A standard silver-impregnated dressing applied to a closed surgical incision for 5-7 days post-operatively. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Height | centimeters | Data missing from 1 subject. | Mean | Standard Deviation | centimeters |
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| Weight | kilograms | Mean | Standard Deviation | kilograms |
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| Body Mass Index | Data missing for 1 subject. | Mean | Standard Deviation | kg/m^2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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:
| Modified Intent-To-Treat | Posted | Count of Participants | Participants | within 90 days after TKA revision |
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| Secondary | Number of Participants With Surgical Site Infection (SSI) (Superficial or Deep) | 90 day subject incidence of any SSI (superficial or deep) | Modified Intent-To-Treat | Posted | Count of Participants | Participants | 90 days after TKA revision |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Deep Surgical Site Infection | 90 day subject incidence of deep surgical site infection | Modified Intent-To-Treat | Posted | Count of Participants | Participants | 90 days after TKA revision |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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:
| Intent-To-Treat | Posted | Count of Participants | Participants | within 90 days after TKA revision |
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104 days
The Safety Population was utilized for reporting purposes. The Safety Population includes all randomized subjects with at least 1 application of study treatment. Subjects that were randomized but did not receive application of study treatment were withdrawn from the study and therefore not included in the Safety Population. Subjects in the Safety Population were counted under the treatment received irrespective of the assigned treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Closed Incision Negative Pressure Therapy (ciNPT) | Prevena Peel & Place or Prevena Plus Customizable Dressing and ActiVAC Therapy Unit or Prevena Plus Therapy Unit 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. | 1 | 149 | 17 | 149 | 24 | 149 |
| EG001 | Standard of Care Dressing | Silver impregnated dressing Standard of Care Dressing: A standard silver-impregnated dressing applied to a closed surgical incision for 5-7 days post-operatively. | 0 | 140 | 23 | 140 | 24 | 140 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
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| Clostridium difficile colitis | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
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| Asthenia | General disorders | MedDRA (22.0) | Systematic Assessment |
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| Hypertensive Heart Disease | Cardiac disorders | MedDRA (22.0) | Systematic Assessment | Hypertensive Coronary Disease Death |
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| Fibrosis | General disorders | MedDRA (22.0) | Systematic Assessment |
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| Swelling | General disorders | MedDRA (22.0) | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
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| Postoperative wound infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
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| Stitch abscess | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
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| Viral Infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
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| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
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| Incision site pain | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
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| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
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| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
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| Radius fracture | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
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| Rib fracture | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
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| Stress fracture | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
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| Tendon rupture | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
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| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
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| Arthritis infective | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
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| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
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| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Systematic Assessment |
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| Loss of consciousness | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
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| Unresponsive to stimuli | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
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| Mental status change | Psychiatric disorders | MedDRA (22.0) | Systematic Assessment |
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| Psychotic disorder | Psychiatric disorders | MedDRA (22.0) | Systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
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| Arthrotomy | Surgical and medical procedures | MedDRA (22.0) | Systematic Assessment |
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| Hip arthroplasty | Surgical and medical procedures | MedDRA (22.0) | Systematic Assessment |
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| Joint manipulation | Surgical and medical procedures | MedDRA (22.0) | Systematic Assessment |
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| Knee arthroplasty | Surgical and medical procedures | MedDRA (22.0) | Systematic Assessment |
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| Wound drainage | Surgical and medical procedures | MedDRA (22.0) | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blister | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
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| Wound Drainage | Surgical and medical procedures | MedDRA (22.0) | Systematic Assessment |
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| Pain | General disorders | MedDRA (22.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Research | KCI | 3M | (210) 515-4060 | actate@mmm.com |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 8, 2019 | Sep 2, 2020 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D000072836 | Surgical Wound |
| D014947 | Wounds and Injuries |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D016459 | Prosthesis-Related Infections |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| ID | Term |
|---|---|
| D013568 | Pathological Conditions, Signs and Symptoms |
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