Complications; Arthroplasty, Infection or InflammationNCT02355691

Improvement in Wound Healing With Negative Pressure Wound Therapy for Postoperative Total Hip Arthroplasty

A study testing PREVENA in people with Complications; Arthroplasty, Infection or Inflammation and Wound Complication, run by University of North Carolina, Chapel Hill at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Complications; Arthroplasty, Infection or Inflammation, Wound Complication
What is being tested?: PREVENA
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteUnited States
Study dates: May 2015to May 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult patients undergoing primary total hip arthroplasty.

Who cannot join

age less than 18 y/o
Total hip arthroplasty for fracture
Revision or conversion total hip arthroplasty
inability to personally consent to participation due to cognitive impairment, intoxication or sedation
multiple surgical procedures
Patients taking immune modulating medication(prednisone, methotrexate, anakinra, etc.)
skin hypersensitivity to acrylic adhesive or silver.
Inability to care for dressing due to physical or mental incapacitation

Trial locations and contacts

1 site in 1 country.

United States1 site

UNC Orthopaedics
Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

For the target population of adult patients following primary total hip arthroplasty, the randomized clinical trial will be used to evaluate the efficacy of the use of a mobile negative pressure wound therapy(NPWT) device compared to a standard absorptive dressing in the immediate postoperative period. We will apply two dressing types and evaluate the postoperative wounds with a wound scoring system (ASEPSIS) that incorporates multiple variables of wound infection risk.

Conditions: Complications; Arthroplasty, Infection or Inflammation, Wound Complication
Being tested: PREVENA
Medical subject headings: Infections, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PREVENADevice
Also called KCI PREVENA Incision Management system
The device is a sealed negative pressure wound therapy tool. The device will be placed on the skin during surgery and left in place until their followup at 7 days.

Study groups in NCT02355691
Study group	Role	What they receive
PREVENA Group	Experimental	Patients will be treated with the PREVENA negative pressure device following total hip arthroplasty. This dressing will be used for a period of seven days. Receives: Device: PREVENA
Standard group	No intervention	Patients will be treated with the standard absorptive dressing following total hip arthroplasty.

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Wound Healing Scores by the ASEPSIS Criteria
A method of evaluating wounds for infection risk that incorporates multiple wound healing factors such as erythema, drainage, and dehiscence is the ASEPSIS (Additional treatment, presence of Serous discharge, Erythema, Purulent exudate, Separation of the deep tissue, Isolation of bacteria, and duration of inpatient Stay) wound scoring system. Originally developed and validated for cardiac surgery sternal wounds, ASEPSIS evaluates the wound for the severity of multiple factors linked with surgical site infection. This includes dehiscence, exudate/discharge, and erythema. The higher the score, the more likely a surgical site infection will be present. This score will give us a more diverse picture of postoperative wound healing and the influence of Negative Pressure Wound Therapy. Scores can range from 0 to 65, with most scores expected at the lower scale.
Measured: (Single point evaluation)-2 weeks post surgery visit

Secondary outcomes (1)

Number of Participants With Infection
The investigators will continue to monitor the patients for development of an acute postoperative infection. A deep infection refers to an infection below the superficial soft tissue and likely involving the prosthesis. This will be evaluated by the musculoskeletal infection society consensus on total joint infection.
Criteria include:(Either one major criteria or four minor criteria) Major criteria Sinus track communicating with the prosthesis Two separate cultures from the joint positive for the same organism
Minor criteria Elevated erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) Elevated synovial leukocyte count Elevated synovial neutrophil percentage Purulent drainage from the joint One positive fluid culture from the joint Histological analysis of tissue showing more than 5 neutrophils per high power field in 5 fields
Measured: (Single point evaluation)-6 weeks post surgery visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2015May 2017

First posted4 Feb 2015 (estimated)
Study startMay 2015
Primary completionMay 2017
Study completionMay 2017

Why it stopped: Loss of Personnel

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Complications; Arthroplasty, Infection or InflammationStudies of the same condition, open and under way.
More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02355691
Sponsor's protocol ID: 14-1920
Status last verified: Mar 2018
First submitted: 30 Jan 2015
Last updated: 17 Apr 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Improvement in Wound Healing With Negative Pressure Wound Therapy for Postoperative Total Hip Arthroplasty
ClinicalTrials.gov ID: NCT02355691
Acronym / sponsor ID: 14-1920
Conditions: Complications; Arthroplasty, Infection or Inflammation, Wound Complication
Study type: Interventional
Recruitment status: TerminatedReason stopped: Loss of Personnel
Enrolment: 16 participants (actual)
Lead sponsor: University of North Carolina, Chapel HillUniversity, hospital or other
Collaborators: Kinetic Concepts, Inc.
Study start: May 2015
Primary completion: May 2017 (actual)
Study completion: May 2017 (actual)
First posted: 4 Feb 2015 (estimated)
Results: Posted 17 Apr 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
PREVENA Group	Experimental	Device: PREVENAPatients will be treated with the PREVENA negative pressure device following total hip arthroplasty. This dressing will be used for a period of seven days.
Standard group	No intervention	–Patients will be treated with the standard absorptive dressing following total hip arthroplasty.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Adult patients undergoing primary total hip arthroplasty.

Key exclusion criteria (8 listed)

age less than 18 y/o
Total hip arthroplasty for fracture
Revision or conversion total hip arthroplasty
inability to personally consent to participation due to cognitive impairment, intoxication or sedation
multiple surgical procedures

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PREVENAAlso: KCI PREVENA Incision Management systemThe device is a sealed negative pressure wound therapy tool. The device will be placed on the skin during surgery and left in place until their followup at 7 days.	Device	PREVENA Group

Primary outcome

Mean Wound Healing Scores by the ASEPSIS Criteria
Time frame: (Single point evaluation)-2 weeks post surgery visit
A method of evaluating wounds for infection risk that incorporates multiple wound healing factors such as erythema, drainage, and dehiscence is the ASEPSIS (Additional treatment, presence of Serous discharge, Erythema, Purulent exudate, Separation of the deep tissue, Isolation of bacteria, and duration of inpatient Stay) wound scoring system. Originally developed and validated for cardiac surgery sternal wounds, ASEPSIS evaluates the wound for the severity of multiple factors linked with surgical site infection. This includes dehiscence, exudate/discharge, and erythema. The higher the score, the more likely a surgical site infection will be present. This score will give us a more diverse picture of postoperative wound healing and the influence of Negative Pressure Wound Therapy. Scores can range from 0 to 65, with most scores expected at the lower scale.

1 secondary outcome

Number of Participants With Infection
Time frame: (Single point evaluation)-6 weeks post surgery visit

Results and safety

Results posted to the registry on 17 Apr 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PREVENA Group	7	0
Standard Group	9	0

Primary outcome: Mean Wound Healing Scores by the ASEPSIS Criteria

Time frame: (Single point evaluation)-2 weeks post surgery visit. Mean (Full Range). Unit: units on a scale

Measure	PREVENA Group n = 7	Standard Group n = 9
Value	0.57 (0 to 1)	1.66 (0 to 16)

Population analysed: Measured outcomes for all patients that completed the treatment

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Patients that enrolled in the study were followed and seen at 2 weeks postoperatively. The study was terminated prior to patients returning for their 6 week visit so they were not seen by the research staff after 2 weeks. All patients were followed by chart review to confirm adverse events within 6 months of enrolling in the study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PREVENA Group	0 of 7 (0%)	0 of 7 (0%)	0 of 7
Standard Group	0 of 9 (0%)	1 of 9 (11.1%)	0 of 9

Limitations and caveats (from the sponsor): Major Limitation-Study could not be completed due to the loss of research personnel early during the trial. We did not have the funding to provide for an additional personnel.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
PREVENA websiteLink provided by the sponsor.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Daniel J Del Gaizo, MD principal investigator

UNC Orthopaedics

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing PREVENA in people with Complications; Arthroplasty, Infection or Inflammation and Wound Complication, run by University of North Carolina, Chapel Hill at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Wound Healing Scores by the ASEPSIS Criteria (time frame: (Single point evaluation)-2 weeks post surgery visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02355691.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2018.