ClinicalTrials.gg
RecruitingNCT05685628CINNAMONUpdated Nov 10, 2026

Evaluation of the Quality of Life Induced by the Cinnamon Anti-odor Dressing in Patients With Malodorous Wounds

An interventional study of Cinnamon dressing and Charcoal dressing in Malodorous Wounds (Chronic, Malignant or Infected Wounds), sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 7 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2023; still recruiting 3 years 1 month later.
Updated Nov 10, 20261 site added1 site removedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
98
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Malodorous Wounds (Chronic, Malignant or Infected Wounds)

Keywords

  • Malodorous wounds
  • Malignant wound
  • Symptom management
03

In context

Bronchiolitis Obliterans Syndrome

714 studies on the registry are indexed under Bronchiolitis Obliterans Syndrome; 128 are open to participants now.

This study's planned enrollment of 98 is above the median of 50 across 565 interventional studies indexed under Bronchiolitis Obliterans Syndrome.

Browse Bronchiolitis Obliterans Syndrome studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
98 participants (estimated)

Study arms

  • Experimental
    Cinnamon dressing group

    Use of the cinnamon dressing for 14 days

    Other: Cinnamon dressing

  • Active comparator
    Charcoal dressing Group

    Use of the charcoal dressing for 14 days

    Other: Charcoal dressing

Interventions

  • OtherCinnamon dressing

    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.

  • OtherCharcoal dressing

    Use of a secondary non-occlusive activated charcoal dressing (brand of your choice)

06

What researchers measure

Primary outcomes

  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.

    Time frame: Day 0 and 14

Secondary outcomes

  1. Odor discomfort / patient

    Discomfort related to the smell felt in the last 24 hours (from 0 to 10) assessed by the patient.

    Time frame: 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

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: Day 1

  6. Cutaneous reaction or dressing discomfort

    Patient's questionnaire

    Time frame: Day 14

  7. Dressing qualities

    Nurse's questionnaire: dressing flexibility, application, opening

    Time frame: Day 3

07

Study locations

3 of 7 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — Data are own by Assistance Publique - Hôpitaux de Paris, please contact sponsor for further information.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2023 (actual). Primary completion is estimated for Apr 2027, 42 months after the start.

Of 110 non-industry interventional studies with no phase under Bronchiolitis Obliterans Syndrome, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 50. This study's planned 42 months is above that.

Counting every sponsor, half of 122 studies reached it within 22 months; a quarter within 11 and three quarters within 54.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 7, 2022
First posted
Jan 17, 2023
StartActual
Oct 4, 2023
Primary completionEst.
Apr 19, 2027
CompletionEst.
Apr 19, 2027
Last update
Nov 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
1 site added, 1 site removed
Show site
  • Hospitalisation à domicile de la région de Melun · Vaux-le-Pénil, France
Show 1 removed
  • Hospitalisation à domicile de la région de Melun · Vaux-le-Pénil, France
Nov 10, 2026
Site contacts
Changed at 1 site. See the sites
Show the site
  • Hôpital Henri Mondor · Créteil, FranceContact f•••@aphp.fr · •••2516→a•••@aphp.fr · •••4939
Nov 10, 2026
Show all 1 update
  1. Nov 10, 2026
    1 site added, 1 site removed
    Show site
    • Hospitalisation à domicile de la région de Melun · Vaux-le-Pénil, France
    Show 1 removed
    • Hospitalisation à domicile de la région de Melun · Vaux-le-Pénil, France
    Site contacts Changed at 1 site. See the sites
    Show the site
    • Hôpital Henri Mondor · Créteil, FranceContact f•••@aphp.fr · •••2516→a•••@aphp.fr · •••4939
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05685628
Responsible party
Sponsor
First posted
Jan 17, 2023
Start date
Oct 4, 2023
Primary completion
Apr 19, 2027 (estimated)
Completion
Apr 19, 2027 (estimated)
Last update
Nov 10, 2026

Study contacts

Maxime CHERON, IDE
Contact
maxime.cheron@curie.fr
01 44 32 42 34 ext. +33
Isabelle FROMANTIN, IDE
study director · Institut Curie

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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