Evaluation of the Quality of Life Induced by the Cinnamon Anti-odor Dressing in Patients With Malodorous Wounds
Malodorous Wounds (Chronic, Malignant or Infected Wounds)
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 98 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
Refer to "Detailed description".
Read the full 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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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:
- 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.
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- No masking
Cinnamon dressing group
Use of the cinnamon dressing for 14 days
Other: Cinnamon dressing
Charcoal dressing Group
Use of the charcoal dressing for 14 days
Other: Charcoal dressing
Cinnamon dressing OTHER
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 dressing OTHER
Use of a secondary non-occlusive activated charcoal dressing (brand of your choice)
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
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.
Secondary measures
Odor discomfort / patient
Time frame: Day 0, 7 and 14.
Discomfort related to the smell felt in the last 24 hours (from 0 to 10) assessed by the patient.
Odor discomfort / nurse
Time frame: Day 0, 7 and 14.
Discomfort related to the smell felt (from 0 to 10) assessed by the nurse performing the treatment
Odor discomfort / family
Time frame: Day 0, 7 and 14.
Discomfort related to the smell felt (from 0 to 10) assessed by the family present (if it's practical)
SEFI® Scale to assess appetite
Time frame: Day 0, 7 and 14.
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
Odor discomfort / patient
Time frame: Day 1
Discomfort related to the smell felt (from 0 to 10) assessed by the patient just before the first dressing change
Cutaneous reaction or dressing discomfort
Time frame: Day 14
Patient's questionnaire
Dressing qualities
Time frame: Day 3
Nurse's questionnaire: dressing flexibility, application, opening
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (7)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
7 locations
Hôpital Henri MondorCréteil, FranceRecruiting
Hôpital Henri MondorCréteil, FranceNot yet recruiting
Hospitalisation à domicile Fondation Santé ServiceLevallois-Perret, FranceNot yet recruiting
Hospitalisation à Domicile AP-HPParis, FranceRecruiting
Institut CurieParis, FranceRecruiting
Hôpital Sainte PérineParis, FranceActive, not recruiting
Hospitalisation à domicile de la région de MelunVaux-le-Pénil, FranceNot yet recruiting
Study team and timeline
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Study start
- Oct 4, 2023 Actual
- Primary completion
- Apr 19, 2027 Estimated
- Study completion
- Apr 19, 2027 Estimated
- First posted
- Jan 17, 2023 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
Evaluation of the Quality of Life Induced by the Cinnamon Anti-odor Dressing in Patients With Malodorous Wounds: a Multicenter Randomized Controlled Trial
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026