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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Refer to "Detailed description". Read more about this study

Who is it for?
Ages 18 years and older
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
  • Hôpital Henri Mondor

    Créteil, 94 000

    Coralie BOITEAU, IDE, 01 49 81 21 11 ext. +33, coralie.boiteau@aphp.fr

    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

    Not yet 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

    Recruiting
  • Hôpital Sainte Périne

    Paris, 75 016

    Active, not 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

    Not yet recruiting

Other trials in France

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 groups in NCT05685628
Study groupRoleWhat they receive
Cinnamon dressing groupExperimentalUse of the cinnamon dressing for 14 days
Receives: Other: Cinnamon dressing
Charcoal dressing GroupActive comparatorUse 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.

  1. 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)
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. Cutaneous reaction or dressing discomfort

    Patient's questionnaire

    Measured: Day 14

  7. 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.

  1. First posted17 Jan 2023
  2. Study start4 Oct 2023
  3. Primary completion19 Apr 2027 (estimated)
  4. Study completion19 Apr 2027 (estimated)

Resources

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)
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.

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.

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