Pressure UlcersPhase 4NCT02689310
Leptospermum Scoparium Honey and Wound Care for Pressure Ulcers
A Phase 4 study testing Leptospermum scoparium honey in people with Pressure Ulcers, run by New York City Health and Hospitals Corporation at 1 site in United States.
Trial summary
The investigators hypothesize that the use of leptospermum scoparium honey as a type of dressing and/or debridement agent on stage III or IV pressure ulcers has an increased efficacy and safety compared to the current treatment protocol that includes the use of hydrogel/Vaseline, collagenase, and silver alginate… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pressure Ulcers
- What is being tested?
- Leptospermum scoparium honey
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2018to Apr 2018
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult (18 years old and older)
- Newly admitted patients with a diagnosis Pressure Ulcers (Stages III and IV) or patients who develop nosocomial pressure ulcers Stage III and Stage IV
- Ability to provide written informed consent (either patient or legal personal representative)
Who cannot join
- Patient/representative refuses to give written informed consent
- Patient diagnosed with terminal illness
Trial locations and contacts
1 site in 1 country.
United States1 site
NYC Health + Hospitals/Coney Island
Brooklyn, New York, 11235
About this study
The investigators hypothesize that the use of leptospermum scoparium honey as a type of dressing and/or debridement agent on stage III or IV pressure ulcers has an increased efficacy and safety compared to the current treatment protocol that includes the use of hydrogel/Vaseline, collagenase, and silver alginate dressings as the standard of care. Utilizing a non-inferiority trial, it is expected that the use of leptospermum scoparium as a treatment for Stage III and Stage IV pressure ulcers will not be inferior to the comparison treatment of standard of care wound dressings. Moreover, this research design will enable the research team to determine if the honey based dressings are equivalent to or superior to the comparison treatment.
Therefore, the investigators specific study objectives are as follows:
- Primary Objectives: Determine if the use of honey as an alternative treatment will reduce site inflammation/irritation and pain associated with pressure ulcers compared to the standard treatment options. Specifically, the investigators will monitor patient PUSH scores, Braden Risk Scale scores, granulation and/or epithelial tissue progression, length of time to heal, patient pain assessments via the Wong Baker Face or Numeric Scale, wound odors, and incidence of adverse events (measured by allergies, stinging sensations, bacterial infections that warrant antibiotic intervention, etc.).
- Secondary Objective: Patients in the honey treatment group will have lower costs per healed ulcer than patients in the standard collagenase treatment group.
Read the detailed description
Design: Non-inferiority Trial. This design is intended to demonstrate that Leptospermum scoparium Honey treatment is no worse than the standard treatment for pressure ulcers.
Data Collection Procedures:
Members of the research team will administer all wound care treatments on all of the patients in this research project. After initial evaluation and documentation of the presence of pressure ulcers, patients with Stage III and Stage IV ulcers are randomized into the two groups; treatment and control. Patients that develop nosocomial Stage III and Stage IV pressure ulcers will also be included in this study and randomly placed into one of the groups. The following protocol will be followed.
- Conditions
- Pressure Ulcers
- Being tested
- Leptospermum scoparium honey, Standard of Care Treatment
- Keywords
- Wound Care, Medical Grade Honey, Pressure Ulcers
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leptospermum scoparium honeyOther
No information available- PI left- study being withdrawn.
Standard of Care TreatmentOther
No information available- PI left- study being withdrawn.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care - Stage III Pressure Ulcers | Other | Patients with a stage III pressure ulcer who are randomized into this arm will be given standard treatment (hydrogel, collegense, and silver alginate dressings). Receives: Other: Standard of Care Treatment |
| Honey Treatment - Stage III Pressure Ulcers | Experimental | Patients with a stage III pressure ulcer who are randomized into this treatment arm will be given leptospermum scoparium honey dressings for treatment of their wound. Receives: Other: Leptospermum scoparium honey |
| Standard Care - Stage IV Pressure Ulcers | Other | Patients with a stage IV pressure ulcer who are randomized into this arm will be given standard treatment (hydrogel, collegense, and silver alginate dressings). Receives: Other: Standard of Care Treatment |
| Honey Treatment - Stage IV Pressure Ulcers | Experimental | Patients with a stage IV pressure ulcer who are randomized into this treatment arm will be given leptospermum scoparium honey dressings for treatment of their wound. Receives: Other: Leptospermum scoparium honey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Score on the Pressure Ulcer Scale for Healing (PUSH) Scale
Developed by the National Pressure Ulcer Advisory Panel (NPUAP) as a quick and reliable tool to monitor the change in pressure ulcer status over time and has been incorporated as a standard assessment tool in acute care settings.
Measured: 6 weeks
Odor (scored as no odor, odor on dressing change, odor all the time)
Observed by staff and patient, will be scored as no odor, odor on dressing change, odor all the time.
Measured: 6 weeks
Incidence of adverse events
Measured: 6 weeks
Braden Scale assessment
Measured: 6 weeks
Irritation
Presence or absence of irritation as determined by clinical observation
Measured: 6 weeks
Inflammation
Presence or absence of irritation as determined by clinical observation
Measured: 6 weeks
Pain
Pain in and around pressure ulcer assessed by tenderness to the touch by clinician (recorded as present or absent)
Measured: 6 weeks
Secondary outcomes (1)
Costs treated per ulcer
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (estimated)
- Study start1 Mar 2018 (estimated)
- Primary completionApr 2018 (estimated)
- Study completionApr 2018 (estimated)
Why it stopped: No patients recruited. Study didn't get off the ground. PI left.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcersStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York City Health and Hospitals Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02689310
- Sponsor's protocol ID
- Honey & Wound Care
- Status last verified
- Apr 2018
- First submitted
- 8 Feb 2016
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leptospermum Scoparium Honey and Wound Care for Pressure Ulcers
- ClinicalTrials.gov ID
- NCT02689310
- Acronym / sponsor ID
- Honey & Wound Care
- Conditions
- Pressure Ulcers
- Keywords
- Wound Care, Medical Grade Honey, Pressure Ulcers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients recruited. Study didn't get off the ground. PI left.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- New York City Health and Hospitals CorporationUniversity, hospital or other
- Study start
- 1 Mar 2018 (estimated)
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 23 Feb 2016 (estimated)
- 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.
The investigators hypothesize that the use of leptospermum scoparium honey as a type of dressing and/or debridement agent on stage III or IV pressure ulcers has an increased efficacy and safety compared to the current treatment protocol that includes the use of hydrogel/Vaseline, collagenase, and silver alginate dressings as the standard of care. Utilizing a non-inferiority trial, it is expected that the use of leptospermum scoparium as a treatment for Stage III and Stage IV pressure ulcers will not be inferior to the comparison treatment of standard of care wound dressings. Moreover, this research design will enable the research team to determine if the honey based dressings are equivalent to or superior to the comparison treatment.
Therefore, the investigators specific study objectives are as follows:
- Primary Objectives: Determine if the use of honey as an alternative treatment will reduce site inflammation/irritation and pain associated with pressure ulcers compared to the standard treatment options. Specifically, the investigators will monitor patient PUSH scores, Braden Risk Scale scores, granulation and/or epithelial tissue progression, length of time to heal, patient pain assessments via the Wong Baker Face or Numeric Scale, wound odors, and incidence of adverse events (measured by allergies, stinging sensations, bacterial infections that warrant antibiotic intervention, etc.).
- Secondary Objective: Patients in the honey treatment group will have lower costs per healed ulcer than patients in the standard collagenase treatment group.
Detailed description
Design: Non-inferiority Trial. This design is intended to demonstrate that Leptospermum scoparium Honey treatment is no worse than the standard treatment for pressure ulcers.
Data Collection Procedures:
Members of the research team will administer all wound care treatments on all of the patients in this research project. After initial evaluation and documentation of the presence of pressure ulcers, patients with Stage III and Stage IV ulcers are randomized into the two groups; treatment and control. Patients that develop nosocomial Stage III and Stage IV pressure ulcers will also be included in this study and randomly placed into one of the groups. The following protocol will be followed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard Care - Stage III Pressure Ulcers | Other | Other: Standard of Care TreatmentPatients with a stage III pressure ulcer who are randomized into this arm will be given standard treatment (hydrogel, collegense, and silver alginate dressings). |
| Honey Treatment - Stage III Pressure Ulcers | Experimental | Other: Leptospermum scoparium honeyPatients with a stage III pressure ulcer who are randomized into this treatment arm will be given leptospermum scoparium honey dressings for treatment of their wound. |
| Standard Care - Stage IV Pressure Ulcers | Other | Other: Standard of Care TreatmentPatients with a stage IV pressure ulcer who are randomized into this arm will be given standard treatment (hydrogel, collegense, and silver alginate dressings). |
| Honey Treatment - Stage IV Pressure Ulcers | Experimental | Other: Leptospermum scoparium honeyPatients with a stage IV pressure ulcer who are randomized into this treatment arm will be given leptospermum scoparium honey dressings for treatment of their wound. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult (18 years old and older)
- Newly admitted patients with a diagnosis Pressure Ulcers (Stages III and IV) or patients who develop nosocomial pressure ulcers Stage III and Stage IV
- Ability to provide written informed consent (either patient or legal personal representative)
Key exclusion criteria (2 listed)
- Patient/representative refuses to give written informed consent
- Patient diagnosed with terminal illness
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 |
|---|---|---|
| Leptospermum scoparium honeyNo information available- PI left- study being withdrawn. | Other | Honey Treatment - Stage III Pressure Ulcers, Honey Treatment - Stage IV Pressure Ulcers |
| Standard of Care TreatmentNo information available- PI left- study being withdrawn. | Other | Standard Care - Stage III Pressure Ulcers, Standard Care - Stage IV Pressure Ulcers |
Primary outcome
Total Score on the Pressure Ulcer Scale for Healing (PUSH) Scale
Time frame: 6 weeks
Developed by the National Pressure Ulcer Advisory Panel (NPUAP) as a quick and reliable tool to monitor the change in pressure ulcer status over time and has been incorporated as a standard assessment tool in acute care settings.
Odor (scored as no odor, odor on dressing change, odor all the time)
Time frame: 6 weeks
Observed by staff and patient, will be scored as no odor, odor on dressing change, odor all the time.
Incidence of adverse events
Time frame: 6 weeks
Braden Scale assessment
Time frame: 6 weeks
Irritation
Time frame: 6 weeks
Presence or absence of irritation as determined by clinical observation
Inflammation
Time frame: 6 weeks
Presence or absence of irritation as determined by clinical observation
Pain
Time frame: 6 weeks
Pain in and around pressure ulcer assessed by tenderness to the touch by clinician (recorded as present or absent)
1 secondary outcome
Costs treated per ulcer
Time frame: 1 year
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 18 Apr 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Leptospermum scoparium honey in people with Pressure Ulcers, run by New York City Health and Hospitals Corporation 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 3 inclusion and 2 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 18 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Total Score on the Pressure Ulcer Scale for Healing (PUSH) Scale (time frame: 6 weeks). The study lists 7 primary outcomes in all. 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 18 Apr 2018.