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
Refer to "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.
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 →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.
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.
Exclusion Criteria:
Use of the cinnamon dressing for 14 days
Other: Cinnamon dressing
Use of the charcoal dressing for 14 days
Other: Charcoal 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.
Use of a secondary non-occlusive activated charcoal dressing (brand of your choice)
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
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.
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.
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.
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.
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
Cutaneous reaction or dressing discomfort
Patient's questionnaire
Time frame: Day 14
Dressing qualities
Nurse's questionnaire: dressing flexibility, application, opening
Time frame: Day 3
Not enrolling at this site.
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.
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.
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 ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Bronchiolitis Obliterans Syndrome →
Assistance Publique - Hôpitaux de Paris →