Malodorous Wounds (Chronic, Malignant or Infected Wounds)CINNAMONNCT05685628
Evaluation of the Quality of Life Induced by the Cinnamon Anti-odor Dressing in Patients With Malodorous Wounds
A study testing Cinnamon dressing and Charcoal dressing in people with Malodorous Wounds (Chronic, Malignant or Infected Wounds), run by Assistance Publique - Hôpitaux de Paris at 7 sites in France.
Trial summary
Refer to "Detailed description". Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malodorous Wounds (Chronic, Malignant or Infected Wounds)
- What is being tested?
- Cinnamon dressing and Charcoal dressing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 7 sitesFrance
- Study dates
- 4 Oct 2023to 19 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 of age with a smelly wound (discomfort > 4/10 expressed by the patient);
- Predictive wound healing >14 days (clinical judgement);
- Patient benefiting from a social security scheme (AME excluded)
- Patient, and curator if applicable, informed and having signed the consent form for participation in the study
Who cannot join
- Patient who has received a secondary charcoal or cinnamon dressing within the last 48 hours
- Patient with pressure ulcer stage 1 or 2
- Patient treated by metronidazole or antimicrobial for < 3 days;
- Patient who cannot communicate his feelings;
- Anosmic patient;
- Patient with cinnamon allergy;
- Persons deprived of their liberty or under guardianship;
- Inability to submit to the medical follow-up of the trial for geographical, social, psychological or cognitive reasons.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
France7 sites, 6 recruiting
- Recruiting
Hôpital Henri Mondor
Créteil, 94 000
Coralie BOITEAU, IDE, 01 49 81 21 11 ext. +33, coralie.boiteau@aphp.fr
- Not yet recruiting
Hôpital Henri Mondor
Créteil, 94 000
Fannie ARNOULT, IDE, 01 49 81 25 16 ext. +33, fannie.arnoult@aphp.fr
- Not yet recruiting
Hospitalisation à domicile Fondation Santé Service
Levallois-Perret, 92 300
Sébastien PERRIGUEY, IDE, 01 71 29 00 72 ext. +33, sebastien.perriguey@fondation-santeservice.fr
- Recruiting
Hospitalisation à Domicile AP-HP
Paris, 75 005
Isabelle CEDOLIN, IDE, 06 23 25 15 34 ext. +33, isabelle.cedolin@aphp.fr
- Recruiting
Institut Curie
Paris, 75 005
Maxime CHERON, IDE, 01 44 32 42 34 ext. +33, maxime.cheron@curie.fr
Isabelle FROMANTIN, IDE, 01 44 32 44 28 ext. +33, isabelle.fromantin@curie.fr
- Active, not recruiting
Hôpital Sainte Périne
Paris, 75 016
- Not yet recruiting
Hospitalisation à domicile de la région de Melun
Vaux-le-Pénil, France, 77 000
Sabine BOURNOT, 01 89 40 43 80 ext. +33, sabine.bournot@live.fr
About this study
Official title: Evaluation of the Quality of Life Induced by the Cinnamon Anti-odor Dressing in Patients With Malodorous Wounds: a Multicenter Randomized Controlled Trial
Refer to "Detailed description".
Read the detailed description
Wounds can smell bad when they are necrotic, infected, malignant or complicated by fistulas or abscesses. The discomfort and evocations (perception) associated with these smells can be different from person to person. Foul odors are often associated with a repulsive effect. Malodorous wounds can have negative social and psychological repercussions (shame, depreciation, isolation).
Malodor is due to the presence of bacteria, whether the wound is colonized or infected. Bacteria release Volatile Organic Compounds (VOCs) that emit these odors. There are a multitude of anti-odor treatments (conventional or not) that highlight the difficulty of effectively treating this symptom.
Charcoal dressings are recommended. Charcoal does not treat the etiology, it is not odorous, but it has the ability to adsorb VOCs.
To treat odor, the most prescribed antibiotic is Metronidazole, because its action targets anaerobic bacteria whose presence increases odor. But repeated prescriptions of antibiotics increase the risk of selection pressure, in addition to possible side effects. It's not efficient in all the situations
Another strategy is the application of local antimicrobials. But it is effective only if the bacteria responsible for the odors are on the surface of the wound, which is not the case if it is a tumor mass, thick necrosis or abscesses.
These local or general treatments do not completely control bad odors in all situations. A new dressing combining adsorption capabilities (reduction of bad odors) with odor release (modification of the perception of residual odors) with cinnamon (CINESTEAM®) is now available.
This work aims to evaluate this new medical device compared to the reference dressing (charcoal) on quality of life, as well as criteria still poorly documented such as discomfort and appetite.
The primary endpoint is the percentage of patients with a reduction of at least 0.4 points in the overall score on the Wound-Qol questionnaire (Quality of life). It is estimated that a 0.4 point reduction in the overall score is a clinically relevant reduction for patients and reflects an improvement in their quality of life. An improvement of 0.4 points is expected in 25% of patients in the control arm (charcoal dressing) and in 55% of patients in the experimental arm (cinnamon dressing).
The study provides for the inclusion of 98 people with malodorous wounds in several hospital located on Ile de France.
Day 0: General data on the wound and current treatments will collected, Wound-Qol scale, lifestyle, discomfort related to smell, evaluation of appetite. The evaluated dressings will positioned on the top of primary dressing. They will fix by a non-occlusive or semi-occlusive fixation. The entire dressing will changed 1 time a day for 14 days.
Day 1: The patient will assess the discomfort related to the smell before changing the dressing.
Day 3: Assessment of the employability of the dressing by the caregiver.
Day 7 and 14: Assessment of the discomfort related to the smell by the patient, the caregiver and the entourage. Appetite will assessed with the Simple Evaluation of Food Intake scale (SEFI). Day 14 only: Wound-Qol scale and self-questionnaire on the appearance of any discomfort(s)/reaction(s) due to the dressing.
- Being tested
- Cinnamon dressing, Charcoal dressing
- Keywords
- Malodorous wounds, Malignant wound, Symptom management
- Medical subject headings
- Bronchiolitis Obliterans Syndrome, Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cinnamon dressingOther
Use of CINESTEAM® as a non-occlusive secondary dressing
CE marked medical device class I, secondary, absorbent, non-adhesive and composed of:
- Anti-odor upper part, adsorbent containing cinnamon powder.
- Weakly absorbent lower part intended to absorb excess exudates.
Charcoal dressingOther
Use of a secondary non-occlusive activated charcoal dressing (brand of your choice)
| Study group | Role | What they receive |
|---|---|---|
| Cinnamon dressing group | Experimental | Use of the cinnamon dressing for 14 days Receives: Other: Cinnamon dressing |
| Charcoal dressing Group | Active comparator | Use of the charcoal dressing for 14 days Receives: Other: Charcoal dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound-Qol
Wound-QoL (Questionnaire on quality of life with chronic wounds) measures the disease-specific, health-related quality of life of patients with chronic wounds. It can be used in clinical and observational studies as well as in daily practice. Two versions are available and we decided to use the original version (Wound-QoL-17) with 17 items. The primary endpoint is the reduction of more than 0.4 points in the overall score of the Wound-Qol quality of life questionnaire between D0 and D14.
Measured: Day 0 and 14
Secondary outcomes (7)
Odor discomfort / patient
Discomfort related to the smell felt in the last 24 hours (from 0 to 10) assessed by the patient.
Measured: Day 0, 7 and 14.
Odor discomfort / nurse
Discomfort related to the smell felt (from 0 to 10) assessed by the nurse performing the treatment
Measured: Day 0, 7 and 14.
Odor discomfort / family
Discomfort related to the smell felt (from 0 to 10) assessed by the family present (if it's practical)
Measured: Day 0, 7 and 14.
SEFI® Scale to assess appetite
SEFI® is a quick and simple tool of assessment of food intake and consists in a visual analogue scale (0 to 10), or evaluation of consumed portions
Measured: Day 0, 7 and 14.
Odor discomfort / patient
Discomfort related to the smell felt (from 0 to 10) assessed by the patient just before the first dressing change
Measured: Day 1
Cutaneous reaction or dressing discomfort
Patient's questionnaire
Measured: Day 14
Dressing qualities
Nurse's questionnaire: dressing flexibility, application, opening
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start4 Oct 2023
- Primary completion19 Apr 2027 (estimated)
- Study completion19 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malodorous Wounds (Chronic, Malignant or Infected Wounds)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle FROMANTIN, IDE, Study director, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05685628
- Sponsor's protocol ID
- APHP220093
- Acronym
- CINNAMON
- Status last verified
- Aug 2026
- First submitted
- 7 Dec 2022
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data are own by Assistance Publique - Hôpitaux de Paris, please contact sponsor for further information.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Quality of Life Induced by the Cinnamon Anti-odor Dressing in Patients With Malodorous Wounds: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05685628
- Acronym / sponsor ID
- CINNAMON / APHP220093
- Keywords
- Malodorous wounds, Malignant wound, Symptom management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 4 Oct 2023 (actual)
- Primary completion
- 19 Apr 2027 (estimated)
- Study completion
- 19 Apr 2027 (estimated)
- First posted
- 17 Jan 2023 (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.
Refer to "Detailed description".
Detailed description
Wounds can smell bad when they are necrotic, infected, malignant or complicated by fistulas or abscesses. The discomfort and evocations (perception) associated with these smells can be different from person to person. Foul odors are often associated with a repulsive effect. Malodorous wounds can have negative social and psychological repercussions (shame, depreciation, isolation).
Malodor is due to the presence of bacteria, whether the wound is colonized or infected. Bacteria release Volatile Organic Compounds (VOCs) that emit these odors. There are a multitude of anti-odor treatments (conventional or not) that highlight the difficulty of effectively treating this symptom.
Charcoal dressings are recommended. Charcoal does not treat the etiology, it is not odorous, but it has the ability to adsorb VOCs.
To treat odor, the most prescribed antibiotic is Metronidazole, because its action targets anaerobic bacteria whose presence increases odor. But repeated prescriptions of antibiotics increase the risk of selection pressure, in addition to possible side effects. It's not efficient in all the situations
Another strategy is the application of local antimicrobials. But it is effective only if the bacteria responsible for the odors are on the surface of the wound, which is not the case if it is a tumor mass, thick necrosis or abscesses.
These local or general treatments do not completely control bad odors in all situations. A new dressing combining adsorption capabilities (reduction of bad odors) with odor release (modification of the perception of residual odors) with cinnamon (CINESTEAM®) is now available.
This work aims to evaluate this new medical device compared to the reference dressing (charcoal) on quality of life, as well as criteria still poorly documented such as discomfort and appetite.
The primary endpoint is the percentage of patients with a reduction of at least 0.4 points in the overall score on the Wound-Qol questionnaire (Quality of life). It is estimated that a 0.4 point reduction in the overall score is a clinically relevant reduction for patients and reflects an improvement in their quality of life. An improvement of 0.4 points is expected in 25% of patients in the control arm (charcoal dressing) and in 55% of patients in the experimental arm (cinnamon dressing).
The study provides for the inclusion of 98 people with malodorous wounds in several hospital located on Ile de France.
Day 0: General data on the wound and current treatments will collected, Wound-Qol scale, lifestyle, discomfort related to smell, evaluation of appetite. The evaluated dressings will positioned on the top of primary dressing. They will fix by a non-occlusive or semi-occlusive fixation. The entire dressing will changed 1 time a day for 14 days.
Day 1: The patient will assess the discomfort related to the smell before changing the dressing.
Day 3: Assessment of the employability of the dressing by the caregiver.
Day 7 and 14: Assessment of the discomfort related to the smell by the patient, the caregiver and the entourage. Appetite will assessed with the Simple Evaluation of Food Intake scale (SEFI). Day 14 only: Wound-Qol scale and self-questionnaire on the appearance of any discomfort(s)/reaction(s) due to the dressing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cinnamon dressing group | Experimental | Other: Cinnamon dressingUse of the cinnamon dressing for 14 days |
| Charcoal dressing Group | Active comparator | Other: Charcoal dressingUse of the charcoal dressing for 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient >18 years of age with a smelly wound (discomfort > 4/10 expressed by the patient);
- Predictive wound healing >14 days (clinical judgement);
- Patient benefiting from a social security scheme (AME excluded)
- Patient, and curator if applicable, informed and having signed the consent form for participation in the study
Key exclusion criteria (8 listed)
- Patient who has received a secondary charcoal or cinnamon dressing within the last 48 hours
- Patient with pressure ulcer stage 1 or 2
- Patient treated by metronidazole or antimicrobial for < 3 days;
- Patient who cannot communicate his feelings;
- Anosmic patient;
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 |
|---|---|---|
| Cinnamon dressingUse of CINESTEAM® as a non-occlusive secondary dressing CE marked medical device class I, secondary, absorbent, non-adhesive and composed of: * Anti-odor upper part, adsorbent containing cinnamon powder. * Weakly absorbent lower part intended to absorb excess exudates. | Other | Cinnamon dressing group |
| Charcoal dressingUse of a secondary non-occlusive activated charcoal dressing (brand of your choice) | Other | Charcoal dressing Group |
Primary outcome
Wound-Qol
Time frame: Day 0 and 14
Wound-QoL (Questionnaire on quality of life with chronic wounds) measures the disease-specific, health-related quality of life of patients with chronic wounds. It can be used in clinical and observational studies as well as in daily practice. Two versions are available and we decided to use the original version (Wound-QoL-17) with 17 items. The primary endpoint is the reduction of more than 0.4 points in the overall score of the Wound-Qol quality of life questionnaire between D0 and D14.
7 secondary outcomes
Odor discomfort / patient
Time frame: Day 0, 7 and 14.
Odor discomfort / nurse
Time frame: Day 0, 7 and 14.
Odor discomfort / family
Time frame: Day 0, 7 and 14.
SEFI® Scale to assess appetite
Time frame: Day 0, 7 and 14.
Odor discomfort / patient
Time frame: Day 1
Cutaneous reaction or dressing discomfort
Time frame: Day 14
Dressing qualities
Time frame: Day 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No. Data are own by Assistance Publique - Hôpitaux de Paris, please contact sponsor for further information.
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.
Isabelle FROMANTIN, IDE study director
Institut Curie
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cinnamon dressing and Charcoal dressing in people with Malodorous Wounds (Chronic, Malignant or Infected Wounds), run by Assistance Publique - Hôpitaux de Paris at 7 sites in France.
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 4 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: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maxime CHERON, IDE (01 44 32 42 34 ext. +33, maxime.cheron@curie.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound-Qol (time frame: Day 0 and 14). 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 31 Aug 2026.