Evaluation of the Quality of Life Induced by the Cinnamon Anti-odor Dressing in Patients With Malodorous Wounds
NCT ID: NCT05685628
Last Updated: 2025-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
98 participants
INTERVENTIONAL
2023-10-04
2027-04-19
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cinnamon dressing group
Use of the cinnamon dressing for 14 days
Cinnamon 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.
Charcoal dressing Group
Use of the charcoal dressing for 14 days
Charcoal dressing
Use of a secondary non-occlusive activated charcoal dressing (brand of your choice)
Interventions
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Cinnamon 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.
Charcoal dressing
Use of a secondary non-occlusive activated charcoal dressing (brand of your choice)
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Isabelle FROMANTIN, IDE
Role: STUDY_DIRECTOR
Institut Curie
Locations
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Hôpital Henri Mondor
Créteil, , France
Hôpital Henri Mondor
Créteil, , France
Hospitalisation à domicile Fondation Santé Service
Levallois-Perret, , France
Hospitalisation à Domicile AP-HP
Paris, , France
Institut Curie
Paris, , France
Hôpital Saint Louis
Paris, , France
Hôpital Sainte Périne
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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APHP220093
Identifier Type: -
Identifier Source: org_study_id
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