We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03274466
Recruitment Status : Completed
First Posted : September 7, 2017
Results First Posted : February 10, 2021
Last Update Posted : August 1, 2022
Sponsor:
Information provided by (Responsible Party):
3M

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Surgical Wound
Revision Total Knee Arthroplasty
Wounds and Injuries
Joint Disease
Musculoskeletal Disease
Prosthesis-Related Infections
Infection
Postoperative Complications
Pathologic Processes
Interventions Device: Closed Incision Negative Pressure Therapy (ciNPT)
Device: Standard of Care Dressing
Enrollment 294
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Closed Incision Negative Pressure Therapy (ciNPT) Standard of Care Dressing
Hide Arm/Group Description

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.

Silver impregnated dressing

Standard of Care Dressing: A standard silver-impregnated dressing applied to a closed surgical incision for 5-7 days post-operatively.

Period Title: Overall Study
Started 147 147
Completed 124 118
Not Completed 23 29
Reason Not Completed
Withdrawal by Subject             7             3
Protocol Specified Withdrawal             5             11
Lost to Follow-up             5             7
Subject Non-compliance             0             1
Adverse Event             3             3
Physician Decision             0             1
Protocol Violation             3             3
Arm/Group Title Closed Incision Negative Pressure Therapy (ciNPT) Standard of Care Dressing Total
Hide Arm/Group Description

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.

Silver impregnated dressing

Standard of Care Dressing: A standard silver-impregnated dressing applied to a closed surgical incision for 5-7 days post-operatively.

Total of all reporting groups
Overall Number of Baseline Participants 147 147 294
Hide Baseline Analysis Population Description
Randomized Subjects (ITT)
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 147 participants 147 participants 294 participants
64.7  (9.48) 65.1  (8.51) 64.9  (9.00)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 147 participants 147 participants 294 participants
Female
83
  56.5%
92
  62.6%
175
  59.5%
Male
64
  43.5%
55
  37.4%
119
  40.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 147 participants 147 participants 294 participants
Hispanic or Latino
14
   9.5%
6
   4.1%
20
   6.8%
Not Hispanic or Latino
125
  85.0%
134
  91.2%
259
  88.1%
Unknown or Not Reported
8
   5.4%
7
   4.8%
15
   5.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 147 participants 147 participants 294 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   0.7%
1
   0.3%
Native Hawaiian or Other Pacific Islander
1
   0.7%
0
   0.0%
1
   0.3%
Black or African American
44
  29.9%
50
  34.0%
94
  32.0%
White
91
  61.9%
88
  59.9%
179
  60.9%
More than one race
10
   6.8%
8
   5.4%
18
   6.1%
Unknown or Not Reported
1
   0.7%
0
   0.0%
1
   0.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 147 participants 147 participants 294 participants
147 147 294
Height   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 147 participants 146 participants 293 participants
169.8  (10.39) 168.3  (10.58) 169.1  (10.49)
[1]
Measure Description: centimeters
[2]
Measure Analysis Population Description: Data missing from 1 subject.
Weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 147 participants 147 participants 294 participants
100.4  (21.79) 96.6  (22.08) 98.5  (21.98)
[1]
Measure Description: kilograms
Body Mass Index   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 147 participants 146 participants 293 participants
34.7  (6.73) 34.2  (7.18) 34.5  (6.96)
[1]
Measure Analysis Population Description: Data missing for 1 subject.
1.Primary Outcome
Title Number of Participants With Surgical Site Complications (SSC)
Hide Description

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
Time Frame within 90 days after TKA revision
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-To-Treat
Arm/Group Title Closed Incision Negative Pressure Therapy (ciNPT) Standard of Care Dressing
Hide Arm/Group Description:

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.

Silver impregnated dressing

Standard of Care Dressing: A standard silver-impregnated dressing applied to a closed surgical incision for 5-7 days post-operatively.

Overall Number of Participants Analyzed 125 128
Measure Type: Count of Participants
Unit of Measure: Participants
5
   4.0%
21
  16.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Closed Incision Negative Pressure Therapy (ciNPT), Standard of Care Dressing
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Modified Intent-To-Treat
Statistical Test of Hypothesis P-Value 0.0013
Comments Threshold for statistical significance: alpha = 0.048
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.22
Confidence Interval (2-Sided) 95%
0.08 to 0.59
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With Surgical Site Infection (SSI) (Superficial or Deep)
Hide Description 90 day subject incidence of any SSI (superficial or deep)
Time Frame 90 days after TKA revision
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-To-Treat
Arm/Group Title Closed Incision Negative Pressure Therapy (ciNPT) Standard of Care Dressing
Hide Arm/Group Description:

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.

Silver impregnated dressing

Standard of Care Dressing: A standard silver-impregnated dressing applied to a closed surgical incision for 5-7 days post-operatively.

Overall Number of Participants Analyzed 125 128
Measure Type: Count of Participants
Unit of Measure: Participants
2
   1.6%
6
   4.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Closed Incision Negative Pressure Therapy (ciNPT), Standard of Care Dressing
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Modified Intent-To-Treat
Statistical Test of Hypothesis P-Value 0.1680
Comments Threshold for Statistical Significance: alpha = 0.048
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.33
Confidence Interval (2-Sided) 95%
0.07 to 1.70
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With Deep Surgical Site Infection
Hide Description 90 day subject incidence of deep surgical site infection
Time Frame 90 days after TKA revision
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-To-Treat
Arm/Group Title Closed Incision Negative Pressure Therapy (ciNPT) Standard of Care Dressing
Hide Arm/Group Description:

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.

Silver impregnated dressing

Standard of Care Dressing: A standard silver-impregnated dressing applied to a closed surgical incision for 5-7 days post-operatively.

Overall Number of Participants Analyzed 125 128
Measure Type: Count of Participants
Unit of Measure: Participants
1
   0.8%
3
   2.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Closed Incision Negative Pressure Therapy (ciNPT), Standard of Care Dressing
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Modified Intent-To-Treat
Statistical Test of Hypothesis P-Value 0.3386
Comments Threshold for Statistical Significance: alpha = 0.048
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.34
Confidence Interval (2-Sided) 95%
0.04 to 3.39
Estimation Comments [Not Specified]
4.Other Pre-specified Outcome
Title Number of Participants With Surgical Site Complication (SSC)
Hide Description

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
Time Frame within 90 days after TKA revision
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-To-Treat
Arm/Group Title Closed Incision Negative Pressure Therapy (ciNPT) Standard of Care Dressing
Hide Arm/Group Description:

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.

Silver impregnated dressing

Standard of Care Dressing: A standard silver-impregnated dressing applied to a closed surgical incision for 5-7 days post-operatively.

Overall Number of Participants Analyzed 147 147
Measure Type: Count of Participants
Unit of Measure: Participants
5
   3.4%
21
  14.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Closed Incision Negative Pressure Therapy (ciNPT), Standard of Care Dressing
Comments Sensitivity analysis of the Primary Endpoint using the Intent-To-Treat population.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0013
Comments Threshold for statistical significance: alpha = 0.048
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.22
Confidence Interval (2-Sided) 95%
0.08 to 0.59
Estimation Comments [Not Specified]
Time Frame 104 days
Adverse Event Reporting Description 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.
 
Arm/Group Title Closed Incision Negative Pressure Therapy (ciNPT) Standard of Care Dressing
Hide Arm/Group Description

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.

Silver impregnated dressing

Standard of Care Dressing: A standard silver-impregnated dressing applied to a closed surgical incision for 5-7 days post-operatively.

All-Cause Mortality
Closed Incision Negative Pressure Therapy (ciNPT) Standard of Care Dressing
Affected / at Risk (%) Affected / at Risk (%)
Total   1/149 (0.67%)      0/140 (0.00%)    
Hide Serious Adverse Events
Closed Incision Negative Pressure Therapy (ciNPT) Standard of Care Dressing
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/149 (11.41%)      23/140 (16.43%)    
Blood and lymphatic system disorders     
Anemia  1  0/149 (0.00%)  0 1/140 (0.71%)  1
Cardiac disorders     
Atrial fibrillation  1  0/149 (0.00%)  0 1/140 (0.71%)  1
Cardiac failure congestive  1  0/149 (0.00%)  0 1/140 (0.71%)  1
Hypertensive Heart Disease  1 [1]  1/149 (0.67%)  1 0/140 (0.00%)  0
Gastrointestinal disorders     
Clostridium difficile colitis  1  0/149 (0.00%)  0 1/140 (0.71%)  1
General disorders     
Asthenia  1  1/149 (0.67%)  1 0/140 (0.00%)  0
Fibrosis  1  2/149 (1.34%)  2 1/140 (0.71%)  1
Swelling  1  1/149 (0.67%)  1 0/140 (0.00%)  0
Infections and infestations     
Appendicitis  1  1/149 (0.67%)  1 0/140 (0.00%)  0
Cellulitis  1  0/149 (0.00%)  0 1/140 (0.71%)  1
Postoperative wound infection  1  2/149 (1.34%)  2 1/140 (0.71%)  1
Stitch abscess  1  1/149 (0.67%)  1 0/140 (0.00%)  0
Urinary tract infection  1  0/149 (0.00%)  0 1/140 (0.71%)  1
Viral Infection  1  0/149 (0.00%)  0 1/140 (0.71%)  1
Injury, poisoning and procedural complications     
Ankle fracture  1  1/149 (0.67%)  1 0/140 (0.00%)  0
Fall  1  0/149 (0.00%)  0 3/140 (2.14%)  3
Incision site pain  1  0/149 (0.00%)  0 1/140 (0.71%)  1
Lower limb fracture  1  0/149 (0.00%)  0 1/140 (0.71%)  1
Post procedural haematoma  1  0/149 (0.00%)  0 1/140 (0.71%)  1
Radius fracture  1  0/149 (0.00%)  0 1/140 (0.71%)  1
Rib fracture  1  0/149 (0.00%)  0 1/140 (0.71%)  1
Stress fracture  1  0/149 (0.00%)  0 1/140 (0.71%)  1
Tendon rupture  1  0/149 (0.00%)  0 1/140 (0.71%)  1
Wound dehiscence  1  1/149 (0.67%)  1 2/140 (1.43%)  2
Metabolism and nutrition disorders     
Dehydration  1  0/149 (0.00%)  0 1/140 (0.71%)  1
Musculoskeletal and connective tissue disorders     
Arthritis infective  1  1/149 (0.67%)  1 1/140 (0.71%)  1
Joint range of motion decreased  1  1/149 (0.67%)  1 0/140 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Diffuse large B-cell lymphoma  1  0/149 (0.00%)  0 1/140 (0.71%)  1
Nervous system disorders     
Loss of consciousness  1  1/149 (0.67%)  1 0/140 (0.00%)  0
Unresponsive to stimuli  1  1/149 (0.67%)  1 0/140 (0.00%)  0
Psychiatric disorders     
Mental status change  1  1/149 (0.67%)  1 0/140 (0.00%)  0
Psychotic disorder  1  0/149 (0.00%)  0 1/140 (0.71%)  1
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  0/149 (0.00%)  0 1/140 (0.71%)  1
Chronic obstructive pulmonary disease  1  0/149 (0.00%)  0 2/140 (1.43%)  2
Pulmonary embolism  1  3/149 (2.01%)  3 0/140 (0.00%)  0
Surgical and medical procedures     
Arthrotomy  1  1/149 (0.67%)  1 0/140 (0.00%)  0
Hip arthroplasty  1  0/149 (0.00%)  0 1/140 (0.71%)  1
Joint manipulation  1  1/149 (0.67%)  1 0/140 (0.00%)  0
Knee arthroplasty  1  0/149 (0.00%)  0 3/140 (2.14%)  3
Wound drainage  1  0/149 (0.00%)  0 2/140 (1.43%)  2
Vascular disorders     
Deep vein thrombosis  1  2/149 (1.34%)  2 0/140 (0.00%)  0
Hypotension  1  0/149 (0.00%)  0 1/140 (0.71%)  1
1
Term from vocabulary, MedDRA (22.0)
Indicates events were collected by systematic assessment
[1]
Hypertensive Coronary Disease Death
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Closed Incision Negative Pressure Therapy (ciNPT) Standard of Care Dressing
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   24/149 (16.11%)      24/140 (17.14%)    
General disorders     
Pain  1  4/149 (2.68%)  5 8/140 (5.71%)  9
Injury, poisoning and procedural complications     
Blister  1  8/149 (5.37%)  8 1/140 (0.71%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  9/149 (6.04%)  9 7/140 (5.00%)  7
Surgical and medical procedures     
Wound Drainage  1  8/149 (5.37%)  8 12/140 (8.57%)  13
1
Term from vocabulary, MedDRA (22.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director of Clinical Research
Organization: KCI | 3M
Phone: (210) 515-4060
EMail: actate@mmm.com
Layout table for additonal information
Responsible Party: 3M
ClinicalTrials.gov Identifier: NCT03274466    
Other Study ID Numbers: KCI.PREVENA.2017.01
First Submitted: September 5, 2017
First Posted: September 7, 2017
Results First Submitted: November 11, 2020
Results First Posted: February 10, 2021
Last Update Posted: August 1, 2022