Negative-Pressure Wound TherapyPrevenaNCT03566641
Negative Pressure Wound Therapy vs Standard Care Dressing
A study testing Negative pressure wound therapy in people with Negative-Pressure Wound Therapy, run by University of Toledo Health Science Campus at 1 site in United States.
Trial summary
A comparison between the efficacy of negative pressure wound therapy and the efficacy of standard care dressing Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Negative-Pressure Wound Therapy
- What is being tested?
- Negative pressure wound therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2018to 15 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consent for participation from the patient or his legal representative
Who cannot join
- Currently infected wounds
- Patients with history of immunosupression
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Negative Pressure Wound Therapy vs Standard Care, for Vascular, Plastic and General Surgery
A comparison between the efficacy of negative pressure wound therapy and the efficacy of standard care dressing
Read the detailed description
The aim of our study is to compare the efficacy of negative pressure wound therapy (Prevena) and standard clinical dressing in terms of prevention of postoperative surgical site infection, length of hospital stay, and total cost of hospitalization among vascular, plastic and general surgery patients.
- Conditions
- Negative-Pressure Wound Therapy
- Being tested
- Negative pressure wound therapy, standard care dressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative pressure wound therapyDevice
Also called Prevena
The application of a vacuum across the surface of a wound through a foam dressing cut to fit the wound.
standard care dressingOther
Also called dray gauze
The application of a standard care dressing (instead of negative pressure wound therapy) across the surface of wound.
| Study group | Role | What they receive |
|---|---|---|
| Negative pressure wound therapy | Experimental | This group of patients will receive negative pressure wound therapy (prevena) as their postoperative wound care method. Receives: Device: Negative pressure wound therapy |
| standard care dressing | Active comparator | This group of patients will receive standard care dressing as their postoperative wound care method. Receives: Other: standard care dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infection
The rate of occurrence of signs and symptoms of surgical site infection
Measured: 30-day postoperative period
Secondary outcomes (3)
length of total hospital stay
number of days of patients hospital stay after the surgery
Measured: 6 months
cost of hospitalization
The total cost in USD of patient's hospitalization
Measured: 6 months
Rate of reoperation
The rate of patients' re-operation after the principal operation
Measured: 30-day postoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2018
- Study start28 Apr 2018
- Primary completion1 Apr 2019
- Study completion15 Apr 2019
Why it stopped: The study did not start, can not secure the products.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Negative-Pressure Wound TherapyStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparing the rate of occurrence of surgical site infection, total hospital cost and length of stay between two groups: group 1 represents patients who receive Prevena for postoperative wound care and group 2 represents patients who receive standard care dressing for the same purpose.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toledo Health Science Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Munier Nazzal, M.S. M.D, University of Toledo Health Science Campus
- Investigators
- munier nazzal, md, Principal investigator, UTMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03566641
- Sponsor's protocol ID
- Prevena V. 11/14/17
- Acronym
- Prevena
- Status last verified
- May 2024
- First submitted
- 25 Apr 2018
- Last updated
- 21 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Negative Pressure Wound Therapy vs Standard Care, for Vascular, Plastic and General Surgery
- ClinicalTrials.gov ID
- NCT03566641
- Acronym / sponsor ID
- Prevena / Prevena V. 11/14/17
- Conditions
- Negative-Pressure Wound Therapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study did not start, can not secure the products.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Toledo Health Science CampusUniversity, hospital or other
- Study start
- 28 Apr 2018 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 15 Apr 2019 (actual)
- First posted
- 25 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A comparison between the efficacy of negative pressure wound therapy and the efficacy of standard care dressing
Detailed description
The aim of our study is to compare the efficacy of negative pressure wound therapy (Prevena) and standard clinical dressing in terms of prevention of postoperative surgical site infection, length of hospital stay, and total cost of hospitalization among vascular, plastic and general surgery patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Comparing the rate of occurrence of surgical site infection, total hospital cost and length of stay between two groups: group 1 represents patients who receive Prevena for postoperative wound care and group 2 represents patients who receive standard care dressing for the same purpose.
| Arm | Type | Receives |
|---|---|---|
| Negative pressure wound therapy | Experimental | Device: Negative pressure wound therapyThis group of patients will receive negative pressure wound therapy (prevena) as their postoperative wound care method. |
| standard care dressing | Active comparator | Other: standard care dressingThis group of patients will receive standard care dressing as their postoperative wound care method. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consent for participation from the patient or his legal representative
Key exclusion criteria (3 listed)
- Currently infected wounds
- Patients with history of immunosupression
- Pregnancy
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 |
|---|---|---|
| Negative pressure wound therapyAlso: PrevenaThe application of a vacuum across the surface of a wound through a foam dressing cut to fit the wound. | Device | Negative pressure wound therapy |
| standard care dressingAlso: dray gauzeThe application of a standard care dressing (instead of negative pressure wound therapy) across the surface of wound. | Other | standard care dressing |
Primary outcome
Surgical site infection
Time frame: 30-day postoperative period
The rate of occurrence of signs and symptoms of surgical site infection
3 secondary outcomes
length of total hospital stay
Time frame: 6 months
cost of hospitalization
Time frame: 6 months
Rate of reoperation
Time frame: 30-day postoperative period
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Individual participant dataSharing planned: No
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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.
munier nazzal, md principal investigator
UTMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Negative pressure wound therapy in people with Negative-Pressure Wound Therapy, run by University of Toledo Health Science Campus 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 3 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: withdrawn, as of the sponsor's last update on 21 May 2024. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Surgical site infection (time frame: 30-day postoperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 May 2024.