WoundNCT05650762
Controlling Malodour In Fungating Wounds Using A Cinnamon-Based Dressing: Observational Study
A study testing Cinesteam in people with Wound, run by CEMAG Care at 1 site in United Kingdom.
Trial summary
The purpose of the study is to observe the contribution of the cinnamon dressing to the reduction of the discomfort associated with the odour felt by the patient and carers. This prospective study aims to collect data on patients living with a malodorous fungating wound. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound
- What is being tested?
- Cinesteam
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2023to Oct 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient > 18 years old with malodorous fungating wounds
- Discomfort > 40/100 expressed by the patient);
- Patients who have capacity to consent;
- Patients who are cognitively able and willing to participate;
- Patients who have a good command of the English language.
Who cannot join
- Patient with pressure ulcers, leg ulcers, diabetic feet ulcers;
- Terminally ill patients whose life expectancy is less than the duration of the protocol;
- Patients having had metronidazole treatment for fewer than 3 days before enrolment in the study;
- Patients who are unable or willing to participate;
- Anosmic patient (with no sense of smell);
- Patient with cinnamon allergy;
Show all 9Show fewer
- Persons deprived of their liberty or under guardianship;
- Unable to take part in study procedures for whatever reason;
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Newcastle upon Tyne Hospital NHS Foundation Trust
Newcastle upon Tyne, NE7 7DN
Fania Pagnamenta, Dr
About this study
The purpose of the study is to observe the contribution of the cinnamon dressing to the reduction of the discomfort associated with the odour felt by the patient and carers.
This prospective study aims to collect data on patients living with a malodorous fungating wound. Quality of life tools will be used to assess the impact of the cinnamon dressing on managing malodorous fungating wounds.
Read the detailed description
There are several anti-odour treatments on the market for managing malodorous wounds but no conclusive data on their efficacy is available. Current treatments like charcoal dressing or topical antimicrobials do not completely manage bad odours in particular for tumoral wounds. In the case of malodorous wounds, the ideal management plan would therefore be to reduce (or neutralise) bad odours, and modify any residual odour so that it becomes more pleasant than unpleasant.
Cinesteam® was specially developed to reduce and manage malodorous wounds. Cinesteam® is a secondary dressing that eliminates unpleasant odours and masks any residual odours with the spice's natural fragrance. This dressing also absorbs excess exudates released by the wound.
The aim of this post-market observational study is to observe the performance of Cinesteam® in controlling malodour in fungating wounds. Patients with malodourous, fungating wounds, above 18 years with a discomfort score of >40/100, with cognitive ability to participate and consent, will be eligible to participate in the study. The study will be conducted on eligible patients in the North East of England, treated at the Newcastle upon Tyne Hospitals NHS Foundation Trust, either as inpatients or in its surrounding community.
The duration of patient participation in the study is 14 days. The research nurse will visit patients on Day0 and perform wound assessment, apply Cinesteam dressing over the standard care primary dressing and answer questionnaires on odour, and discomfort, and also help patients with questionnaires on odour, discomfort, appetite and Quality of life.
The research nurse will change Cinesteam dressing on Day 1, Day 7 +/- 48 hours, and Day 14 +/- 48 hours and perform follow-up assessments on patients' wound condition. Patients or their caregivers who usually change the patient's dressing will change the primary dressing and Cinesteam dressing in-between the research nurse's assessment visits. They will keep a record of these dressing changes in the diary provided.
- Conditions
- Wound
- Being tested
- Cinesteam
- Keywords
- Malodorous wound, Quality of life, Patient and Investigator discomfort
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CinesteamDevice
Cinnamon-based Secondary dressing
| Study group | Role | What they receive |
|---|---|---|
| Cinnamon | Experimental | Not described Receives: Device: Cinesteam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline patient wound odour at different timepoints using a Visual Analogue Scale (VAS-100mm scale), from 0 (no smell) to 100 (worst smell imaginable)
Measured: Baseline visit, one day, 7 and 14 days after baseline visit
Secondary outcomes (3)
Change from baseline patient discomfort associated with the wound odour at different timepoints using a Visual Analogue Scale (VAS-100mm scale), from 0 (no discomfort) to 100 (Unbearable discomfort during the sleeping and waking hours)
Measured: Baseline visit, one day, 7 and 14 days after baseline visit
Change from baseline patient quality of life at different timepoints using the questionnaire of EuroQol 5 Dimension 5 Level (EQ-5D-5L)
Measured: Baseline visit, one day and 14 days after baseline visit
Change from baseline investigator-rating the strength of the wound odour and smell at different timepoints using TELERTM from none odour to very strong odour.
Measured: Baseline visit, one day, 7 and 14 days after baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study startFeb 2023 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CEMAG Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05650762
- Sponsor's protocol ID
- CIN-S22001
- Status last verified
- Dec 2022
- First submitted
- 28 Nov 2022
- Last updated
- 14 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlling Malodour In Fungating Wounds Using A Cinnamon-Based Dressing: Observational Study
- ClinicalTrials.gov ID
- NCT05650762
- Acronym / sponsor ID
- CIN-S22001
- Conditions
- Wound
- Keywords
- Malodorous wound, Quality of life, Patient and Investigator discomfort
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- CEMAG CareIndustry (pharma, biotech, devices)
- Study start
- Feb 2023 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 14 Dec 2022 (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.
The purpose of the study is to observe the contribution of the cinnamon dressing to the reduction of the discomfort associated with the odour felt by the patient and carers.
This prospective study aims to collect data on patients living with a malodorous fungating wound. Quality of life tools will be used to assess the impact of the cinnamon dressing on managing malodorous fungating wounds.
Detailed description
There are several anti-odour treatments on the market for managing malodorous wounds but no conclusive data on their efficacy is available. Current treatments like charcoal dressing or topical antimicrobials do not completely manage bad odours in particular for tumoral wounds. In the case of malodorous wounds, the ideal management plan would therefore be to reduce (or neutralise) bad odours, and modify any residual odour so that it becomes more pleasant than unpleasant.
Cinesteam® was specially developed to reduce and manage malodorous wounds. Cinesteam® is a secondary dressing that eliminates unpleasant odours and masks any residual odours with the spice's natural fragrance. This dressing also absorbs excess exudates released by the wound.
The aim of this post-market observational study is to observe the performance of Cinesteam® in controlling malodour in fungating wounds. Patients with malodourous, fungating wounds, above 18 years with a discomfort score of >40/100, with cognitive ability to participate and consent, will be eligible to participate in the study. The study will be conducted on eligible patients in the North East of England, treated at the Newcastle upon Tyne Hospitals NHS Foundation Trust, either as inpatients or in its surrounding community.
The duration of patient participation in the study is 14 days. The research nurse will visit patients on Day0 and perform wound assessment, apply Cinesteam dressing over the standard care primary dressing and answer questionnaires on odour, and discomfort, and also help patients with questionnaires on odour, discomfort, appetite and Quality of life.
The research nurse will change Cinesteam dressing on Day 1, Day 7 +/- 48 hours, and Day 14 +/- 48 hours and perform follow-up assessments on patients' wound condition. Patients or their caregivers who usually change the patient's dressing will change the primary dressing and Cinesteam dressing in-between the research nurse's assessment visits. They will keep a record of these dressing changes in the diary provided.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cinnamon | Experimental | Device: Cinesteam |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient > 18 years old with malodorous fungating wounds
- Discomfort > 40/100 expressed by the patient);
- Patients who have capacity to consent;
- Patients who are cognitively able and willing to participate;
- Patients who have a good command of the English language.
Key exclusion criteria (9 listed)
- Patient with pressure ulcers, leg ulcers, diabetic feet ulcers;
- Terminally ill patients whose life expectancy is less than the duration of the protocol;
- Patients having had metronidazole treatment for fewer than 3 days before enrolment in the study;
- Patients who are unable or willing to participate;
- Anosmic patient (with no sense of smell);
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 |
|---|---|---|
| CinesteamCinnamon-based Secondary dressing | Device | Cinnamon |
Primary outcome
Change from baseline patient wound odour at different timepoints using a Visual Analogue Scale (VAS-100mm scale), from 0 (no smell) to 100 (worst smell imaginable)
Time frame: Baseline visit, one day, 7 and 14 days after baseline visit
3 secondary outcomes
Change from baseline patient discomfort associated with the wound odour at different timepoints using a Visual Analogue Scale (VAS-100mm scale), from 0 (no discomfort) to 100 (Unbearable discomfort during the sleeping and waking hours)
Time frame: Baseline visit, one day, 7 and 14 days after baseline visit
Change from baseline patient quality of life at different timepoints using the questionnaire of EuroQol 5 Dimension 5 Level (EQ-5D-5L)
Time frame: Baseline visit, one day and 14 days after baseline visit
Change from baseline investigator-rating the strength of the wound odour and smell at different timepoints using TELERTM from none odour to very strong odour.
Time frame: Baseline visit, one day, 7 and 14 days after baseline visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
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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 study testing Cinesteam in people with Wound, run by CEMAG Care at 1 site in United Kingdom.
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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 14 Dec 2022. 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 Kingdom. 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?
Results are not available in the source record.
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?
Change from baseline patient wound odour at different timepoints using a Visual Analogue Scale (VAS-100mm scale), from 0 (no smell) to 100 (worst smell imaginable) (time frame: Baseline visit, one day, 7 and 14 days after baseline visit). 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 14 Dec 2022.