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

• Sponsor: 3M (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03274466
• Collaborator: (none)
• Enrollment: 294
• Locations: 17
• Arms: 2
• Actual Duration (Months): 24.4
• Patients Per Site: 17.3
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Dec 5, 2017
• Actual Primary Completion Date: Nov 27, 2019
• Actual Study Completion Date: Dec 19, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Closed Incision Negative Pressure Therapy (ciNPT) Prevena Peel & Place or Prevena Plus Customizable Dressing and ActiVAC Therapy Unit or Prevena Plus Therapy Unit	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: Prevena Peel & Place Prevena Plus Customizable ActiV.A.C. Therapy Unit Prevena Plus 125 Therapy Unit
Active Comparator: Standard of Care Dressing Silver impregnated dressing	Device: Standard of Care Dressing; A standard silver-impregnated dressing applied to a closed surgical incision for 5-7 days post-operatively.; Other Names: Silver-impregnated dressing, Aquacel Ag Surgical or other equivalent

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Surgical Site Complications (SSC) [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

1. Number of Participants With Surgical Site Infection (SSI) (Superficial or Deep) [90 days after TKA revision]

   90 day subject incidence of any SSI (superficial or deep)

2. Number of Participants With Deep Surgical Site Infection [90 days after TKA revision]

   90 day subject incidence of deep surgical site infection

Other Outcome Measures

1. Number of Participants With Surgical Site Complication (SSC) [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic	Weston	Florida	United States	33331
2	Emory University Orthopedics & Spine Hospital	Tucker	Georgia	United States	30084
3	LSU Health Science Center	New Orleans	Louisiana	United States	70006
4	University of Missouri Health Care	Columbia	Missouri	United States	65212
5	Northwell Health - SouthSide Hospital	Bay Shore	New York	United States	11706
6	New York University (NYU)	New York	New York	United States	10003
7	Hospital for Special Surgery	New York	New York	United States	10021
8	Columbia University Medical Center/New York Presbyterian Hospital	New York	New York	United States	10032
9	Northwell Health - Lenox Hill Hospital	New York	New York	United States	10075
10	Duke University Medical Center	Durham	North Carolina	United States	27705
11	Cleveland Clinic	Cleveland	Ohio	United States	44195
12	Joint Implant Surgeons	New Albany	Ohio	United States	43054
13	Oregon Health & Science University	Portland	Oregon	United States	97239
14	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
15	Rothman Institute - Thomas Jefferson University Hospital	Philadelphia	Pennsylvania	United States	19107
16	Houston Methodist Research Institute	Houston	Texas	United States	77030
17	Virginia Commonwealth University	Richmond	Virginia	United States	32743

Sponsors and Collaborators

• 3M

Investigators

• Principal Investigator: Carlos Higuera, MD, The Cleveland Clinic

Study Documents (Full-Text)

• Study Protocol - Oct 6, 2018
• Statistical Analysis Plan - Aug 8, 2019

More Information

Publications

None provided.

• Responsible Party: 3M
• ClinicalTrials.gov Identifier: NCT03274466
• Other Study ID Numbers: KCI.PREVENA.2017.01
• First Posted: Sep 7, 2017
• Last Update Posted: Aug 1, 2022
• Last Verified: Jan 1, 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: Infections; Communicable Diseases; Prosthesis-Related Infections; Joint Diseases; Musculoskeletal Diseases; Postoperative Complications; Pathologic Processes; Wounds and Injuries; Surgical Wound; Carboxymethylcellulose Sodium

Study Results

Participant Flow

Arm/Group Title	Closed Incision Negative Pressure Therapy (ciNPT)	Standard of Care Dressing
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

Baseline Characteristics

Arm/Group Title	Closed Incision Negative Pressure Therapy (ciNPT)	Standard of Care Dressing	Total
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 Participants	147	147	294
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.7 (9.48)	65.1 (8.51)	64.9 (9.00)
Sex: Female, Male (Count of Participants)
Female	83 56.5%	92 62.6%	175 59.5%
Male	64 43.5%	55 37.4%	119 40.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	14 9.5%	6 4.1%	20 6.8%
Not Hispanic or Latino	125 85%	134 91.2%	259 88.1%
Unknown or Not Reported	8 5.4%	7 4.8%	15 5.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	1 0.7%	1 0.3%
Native Hawaiian or Other Pacific Islander	1 0.7%	0 0%	1 0.3%
Black or African American	44 29.9%	50 34%	94 32%
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%	1 0.3%
Region of Enrollment (participants) [Number]
United States	147 100%	147 100%	294 100%
Height (centimeters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [centimeters]	169.8 (10.39)	168.3 (10.58)	169.1 (10.49)
Weight (kilograms) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilograms]	100.4 (21.79)	96.6 (22.08)	98.5 (21.98)
Body Mass Index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	34.7 (6.73)	34.2 (7.18)	34.5 (6.96)

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Surgical Site Complications (SSC)
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

Outcome Measure Data

Analysis Population Description

Modified Intent-To-Treat

Arm/Group Title	Closed Incision Negative Pressure Therapy (ciNPT)	Standard of Care Dressing
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.
Measure Participants	125	128
Count of Participants [Participants]	5 3.4%	21 14.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Closed Incision Negative Pressure Therapy (ciNPT), Standard of Care Dressing
	Comments
	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
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.22
	Confidence Interval	(2-Sided) 95%; 0.08 to 0.59
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Number of Participants With Surgical Site Infection (SSI) (Superficial or Deep)
Description	90 day subject incidence of any SSI (superficial or deep)
Time Frame	90 days after TKA revision

Outcome Measure Data

Analysis Population Description

Modified Intent-To-Treat

Arm/Group Title	Closed Incision Negative Pressure Therapy (ciNPT)	Standard of Care Dressing
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.
Measure Participants	125	128
Count of Participants [Participants]	2 1.4%	6 4.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Closed Incision Negative Pressure Therapy (ciNPT), Standard of Care Dressing
	Comments
	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
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.33
	Confidence Interval	(2-Sided) 95%; 0.07 to 1.70
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Number of Participants With Deep Surgical Site Infection
Description	90 day subject incidence of deep surgical site infection
Time Frame	90 days after TKA revision

Outcome Measure Data

Analysis Population Description

Modified Intent-To-Treat

Arm/Group Title	Closed Incision Negative Pressure Therapy (ciNPT)	Standard of Care Dressing
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.
Measure Participants	125	128
Count of Participants [Participants]	1 0.7%	3 2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Closed Incision Negative Pressure Therapy (ciNPT), Standard of Care Dressing
	Comments
	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
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.34
	Confidence Interval	(2-Sided) 95%; 0.04 to 3.39
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Other Pre-specified Outcome

Title	Number of Participants With Surgical Site Complication (SSC)
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

Outcome Measure Data

Analysis Population Description

Intent-To-Treat

Arm/Group Title	Closed Incision Negative Pressure Therapy (ciNPT)	Standard of Care Dressing
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.
Measure Participants	147	147
Count of Participants [Participants]	5 3.4%	21 14.3%

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
Statistical Test of Hypothesis	p-Value	0.0013
	Comments	Threshold for statistical significance: alpha = 0.048
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.22
	Confidence Interval	(2-Sided) 95%; 0.08 to 0.59
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

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
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	1/149 (0.7%)		0/140 (0%)
Serious Adverse Events
	Closed Incision Negative Pressure Therapy (ciNPT)		Standard of Care Dressing
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	17/149 (11.4%)		23/140 (16.4%)
Blood and lymphatic system disorders
Anemia	0/149 (0%)	0	1/140 (0.7%)	1
Cardiac disorders
Atrial fibrillation	0/149 (0%)	0	1/140 (0.7%)	1
Cardiac failure congestive	0/149 (0%)	0	1/140 (0.7%)	1
Hypertensive Heart Disease	1/149 (0.7%)	1	0/140 (0%)	0
Gastrointestinal disorders
Clostridium difficile colitis	0/149 (0%)	0	1/140 (0.7%)	1
General disorders
Asthenia	1/149 (0.7%)	1	0/140 (0%)	0
Fibrosis	2/149 (1.3%)	2	1/140 (0.7%)	1
Swelling	1/149 (0.7%)	1	0/140 (0%)	0
Infections and infestations
Appendicitis	1/149 (0.7%)	1	0/140 (0%)	0
Cellulitis	0/149 (0%)	0	1/140 (0.7%)	1
Postoperative wound infection	2/149 (1.3%)	2	1/140 (0.7%)	1
Stitch abscess	1/149 (0.7%)	1	0/140 (0%)	0
Urinary tract infection	0/149 (0%)	0	1/140 (0.7%)	1
Viral Infection	0/149 (0%)	0	1/140 (0.7%)	1
Injury, poisoning and procedural complications
Ankle fracture	1/149 (0.7%)	1	0/140 (0%)	0
Fall	0/149 (0%)	0	3/140 (2.1%)	3
Incision site pain	0/149 (0%)	0	1/140 (0.7%)	1
Lower limb fracture	0/149 (0%)	0	1/140 (0.7%)	1
Post procedural haematoma	0/149 (0%)	0	1/140 (0.7%)	1
Radius fracture	0/149 (0%)	0	1/140 (0.7%)	1
Rib fracture	0/149 (0%)	0	1/140 (0.7%)	1
Stress fracture	0/149 (0%)	0	1/140 (0.7%)	1
Tendon rupture	0/149 (0%)	0	1/140 (0.7%)	1
Wound dehiscence	1/149 (0.7%)	1	2/140 (1.4%)	2
Metabolism and nutrition disorders
Dehydration	0/149 (0%)	0	1/140 (0.7%)	1
Musculoskeletal and connective tissue disorders
Arthritis infective	1/149 (0.7%)	1	1/140 (0.7%)	1
Joint range of motion decreased	1/149 (0.7%)	1	0/140 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma	0/149 (0%)	0	1/140 (0.7%)	1
Nervous system disorders
Loss of consciousness	1/149 (0.7%)	1	0/140 (0%)	0
Unresponsive to stimuli	1/149 (0.7%)	1	0/140 (0%)	0
Psychiatric disorders
Mental status change	1/149 (0.7%)	1	0/140 (0%)	0
Psychotic disorder	0/149 (0%)	0	1/140 (0.7%)	1
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	0/149 (0%)	0	1/140 (0.7%)	1
Chronic obstructive pulmonary disease	0/149 (0%)	0	2/140 (1.4%)	2
Pulmonary embolism	3/149 (2%)	3	0/140 (0%)	0
Surgical and medical procedures
Arthrotomy	1/149 (0.7%)	1	0/140 (0%)	0
Hip arthroplasty	0/149 (0%)	0	1/140 (0.7%)	1
Joint manipulation	1/149 (0.7%)	1	0/140 (0%)	0
Knee arthroplasty	0/149 (0%)	0	3/140 (2.1%)	3
Wound drainage	0/149 (0%)	0	2/140 (1.4%)	2
Vascular disorders
Deep vein thrombosis	2/149 (1.3%)	2	0/140 (0%)	0
Hypotension	0/149 (0%)	0	1/140 (0.7%)	1
Other (Not Including Serious) Adverse Events
	Closed Incision Negative Pressure Therapy (ciNPT)		Standard of Care Dressing
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	24/149 (16.1%)		24/140 (17.1%)
General disorders
Pain	4/149 (2.7%)	5	8/140 (5.7%)	9
Injury, poisoning and procedural complications
Blister	8/149 (5.4%)	8	1/140 (0.7%)	1
Musculoskeletal and connective tissue disorders
Arthralgia	9/149 (6%)	9	7/140 (5%)	7
Surgical and medical procedures
Wound Drainage	8/149 (5.4%)	8	12/140 (8.6%)	13

Limitations/Caveats

[Not Specified]

More Information

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.