CompletedNCT03274466PROMISESUpdated Oct 16, 2024Results posted

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

An interventional study of Closed Incision Negative Pressure Therapy (ciNPT) and Standard of Care Dressing in Surgical Wound, Revision Total Knee Arthroplasty and Wounds and Injuries, sponsored by KCI USA, Inc. Completed at 17 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2024-10-16.

Sponsored by KCI USA, Inc (part of Solventum) · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 294
Allocation: Randomized
Ages: 22 Years and older
Sex: All

Study 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.

Conditions studied

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

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In context

Surgical Wound

315 studies on the registry are indexed under Surgical Wound; 57 are open to participants now.

This study's enrollment of 294 is above the median of 66 across 242 interventional studies indexed under Surgical Wound.

Browse Surgical Wound studies →

Lead sponsor

KCI USA, Inc is the lead sponsor of 18 studies on the registry; none are open to participants now.

First submitted before KCI USA, Inc became part of Solventum.

Browse KCI USA, Inc studies →All Solventum studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 22 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Pre-operative Inclusion Criteria:

The subject:

is at least 22 years of age on the date of
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 (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
9. current or history of cancer or hematological (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
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 , 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 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

Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 294 participants (actual)

Study arms

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)
Active comparator
Standard of Care Dressing
Silver impregnated dressing
Device: Standard of Care Dressing

Interventions

DeviceClosed 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.
Also known as: Prevena Peel & Place, Prevena Plus Customizable, ActiV.A.C. Therapy Unit, Prevena Plus 125 Therapy Unit
DeviceStandard of Care Dressing
A standard silver-impregnated dressing applied to a closed surgical incision for 5-7 days post-operatively.
Also known as: Silver-impregnated dressing, Aquacel Ag Surgical or other equivalent

What researchers measure

Primary outcomes

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
Time frame: within 90 days after TKA revision

Secondary outcomes

Number of Participants With Surgical Site Infection (SSI) (Superficial or Deep)
90 day subject incidence of any SSI (superficial or deep)
Time frame: 90 days after TKA revision
Number of Participants With Deep Surgical Site Infection
90 day subject incidence of deep surgical site infection
Time frame: 90 days after TKA revision

Other outcomes

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
Time frame: within 90 days after TKA revision

Results

Posted Feb 10, 2021

Participant flow

Participant flow — Overall Study
Milestone	Closed Incision Negative Pressure Therapy (ciNPT)	Standard of Care Dressing
Started	147	147
Completed	124	118
Not completed	23	29
Withdrew: Withdrawal by subject	7	3
Withdrew: Protocol specified withdrawal	5	11
Withdrew: Lost to follow-up	5	7
Withdrew: Subject non-compliance	0	1
Withdrew: Adverse event	3	3
Withdrew: Physician decision	0	1
Withdrew: Protocol violation	3	3

Outcome measures

PrimaryNumber 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

Time frame:: within 90 days after TKA revision
Reported as:: Count of participants · Participants

Number of Participants With Surgical Site Complications (SSC)
Participants	Closed Incision Negative Pressure Therapy (ciNPT)	Standard of Care Dressing
Number of Participants With Surgical Site Complications (SSC)	5	21

Statistical analysis

Closed Incision Negative Pressure Therapy (ciNPT) vs Standard of Care Dressing · Cochran-Mantel-Haenszel · p = 0.0013 (Threshold for statistical significance: alpha = 0.048) · Odds ratio (or): 0.22 · 95% CI 0.08 to 0.59

SecondaryNumber of Participants With Surgical Site Infection (SSI) (Superficial or Deep)

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

Time frame:: 90 days after TKA revision
Reported as:: Count of participants · Participants

Number of Participants With Surgical Site Infection (SSI) (Superficial or Deep)
Participants	Closed Incision Negative Pressure Therapy (ciNPT)	Standard of Care Dressing
Number of Participants With Surgical Site Infection (SSI) (Superficial or Deep)	2	6

Statistical analysis

Closed Incision Negative Pressure Therapy (ciNPT) vs Standard of Care Dressing · Cochran-Mantel-Haenszel · p = 0.1680 (Threshold for Statistical Significance: alpha = 0.048) · Odds ratio (or): 0.33 · 95% CI 0.07 to 1.70

SecondaryNumber of Participants With Deep Surgical Site Infection

90 day subject incidence of deep surgical site infection

Time frame:: 90 days after TKA revision
Reported as:: Count of participants · Participants

Number of Participants With Deep Surgical Site Infection
Participants	Closed Incision Negative Pressure Therapy (ciNPT)	Standard of Care Dressing
Number of Participants With Deep Surgical Site Infection	1	3

Statistical analysis

Closed Incision Negative Pressure Therapy (ciNPT) vs Standard of Care Dressing · Cochran-Mantel-Haenszel · p = 0.3386 (Threshold for Statistical Significance: alpha = 0.048) · Odds ratio (or): 0.34 · 95% CI 0.04 to 3.39

Other pre-specifiedNumber 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

Time frame:: within 90 days after TKA revision
Reported as:: Count of participants · Participants

Number of Participants With Surgical Site Complication (SSC)
Participants	Closed Incision Negative Pressure Therapy (ciNPT)	Standard of Care Dressing
Number of Participants With Surgical Site Complication (SSC)	5	21

Statistical analysis

Closed Incision Negative Pressure Therapy (ciNPT) vs Standard of Care Dressing · Cochran-Mantel-Haenszel · p = 0.0013 (Threshold for statistical significance: alpha = 0.048) · Odds ratio (or): 0.22 · 95% CI 0.08 to 0.59

Adverse events

Collected over 104 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Closed Incision Negative Pressure Therapy (ciNPT)	1/149 (0.7%)	17/149 (11.4%)	24/149 (16.1%)
Standard of Care Dressing	0/140 (0%)	23/140 (16.4%)	24/140 (17.1%)

Most frequent serious events

Showing 10 of 42

Most frequent serious events
Event	Closed Incision Negative Pressure Therapy (ciNPT)	Standard of Care Dressing
FallInjury, poisoning and procedural complications	0/149	3/140
Knee arthroplastySurgical and medical procedures	0/149	3/140
Pulmonary embolismRespiratory, thoracic and mediastinal disorders	3/149	0/140
Wound dehiscenceInjury, poisoning and procedural complications	1/149	2/140
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders	0/149	2/140
Wound drainageSurgical and medical procedures	0/149	2/140
FibrosisGeneral disorders	2/149	1/140
Postoperative wound infectionInfections and infestations	2/149	1/140
Deep vein thrombosisVascular disorders	2/149	0/140
AnemiaBlood and lymphatic system disorders	0/149	1/140

Most frequent other events

Most frequent other events
Event	Closed Incision Negative Pressure Therapy (ciNPT)	Standard of Care Dressing
Wound DrainageSurgical and medical procedures	8/149	12/140
ArthralgiaMusculoskeletal and connective tissue disorders	9/149	7/140
PainGeneral disorders	4/149	8/140
BlisterInjury, poisoning and procedural complications	8/149	1/140

Baseline characteristics

Randomized Subjects (ITT)

Age, Continuous
Age, Continuous(years)	Closed Incision Negative Pressure Therapy (ciNPT)	Standard of Care Dressing	Total
Mean	64.7 ± 9.48	65.1 ± 8.51	64.9 ± 9.00

Sex: Female, Male
Sex: Female, Male(Participants)	Closed Incision Negative Pressure Therapy (ciNPT)	Standard of Care Dressing	Total
Female	83	92	175
Male	64	55	119

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Closed Incision Negative Pressure Therapy (ciNPT)	Standard of Care Dressing	Total
Hispanic or Latino	14	6	20
Not Hispanic or Latino	125	134	259
Unknown or Not Reported	8	7	15

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Closed Incision Negative Pressure Therapy (ciNPT)	Standard of Care Dressing	Total
American Indian or Alaska Native	0	0	0
Asian	0	1	1
Native Hawaiian or Other Pacific Islander	1	0	1
Black or African American	44	50	94
White	91	88	179
More than one race	10	8	18
Unknown or Not Reported	1	0	1

Region of Enrollment
Region of Enrollment(participants)	Closed Incision Negative Pressure Therapy (ciNPT)	Standard of Care Dressing	Total
United States	147	147	294

Height
Height(centimeters)	Closed Incision Negative Pressure Therapy (ciNPT)	Standard of Care Dressing	Total
Mean	169.8 ± 10.39	168.3 ± 10.58	169.1 ± 10.49

Weight
Weight(kilograms)	Closed Incision Negative Pressure Therapy (ciNPT)	Standard of Care Dressing	Total
Mean	100.4 ± 21.79	96.6 ± 22.08	98.5 ± 21.98

Body Mass Index
Body Mass Index(kg/m^2)	Closed Incision Negative Pressure Therapy (ciNPT)	Standard of Care Dressing	Total
Mean	34.7 ± 6.73	34.2 ± 7.18	34.5 ± 6.96

Study locations

17 sites

Cleveland Clinic
Weston, Florida 33331, United States
Emory University Orthopedics & Spine Hospital
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

References and documents

Study documents

Study protocol ↗ · Oct 6, 2018
Statistical analysis plan ↗ · Aug 8, 2019

PDFs hosted by the registry, ClinicalTrials.gov.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2017 to primary completion in Nov 2019, 23 months.

Results were first posted in Feb 2021, 1 year 2 months after primary completion.

Of 27 industry-sponsored interventional studies with no phase under Surgical Wound, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 23. This study's 23 months is above that.

Counting every sponsor, half of 126 studies reached it within 18 months; a quarter within 9 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered: Sep 5, 2017
First posted: Sep 7, 2017
StartActual: Dec 5, 2017
Primary completionActual: Nov 27, 2019
CompletionActual: Dec 19, 2019
Results first posted: Feb 10, 2021
Last update: Oct 16, 2024

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Oct 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03274466
Lead sponsor: KCI USA, Inc
Collaborators: 3M
Responsible party: Sponsor
First posted: Sep 7, 2017
Start date: Dec 5, 2017
Primary completion: Nov 27, 2019
Completion: Dec 19, 2019
Results posted: Feb 10, 2021
Last update: Oct 16, 2024

Study contacts

Carlos Higuera, MD

principal investigator · The Cleveland Clinic

Oversight

FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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