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Clinical Trials in France / NCT05685628
Recruiting Not applicable

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

NCT05685628 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Not applicable
Started
2023-10-04
Last updated
2026-08-31

Condition(s) studied

Malodorous Wounds (Chronic, Malignant or Infected Wounds)

Investigational drug(s) / intervention(s)

Cinnamon dressingCharcoal dressing

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)

Study summary

Refer to "Detailed description".

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Wound-Qol — 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.

Trial sites (7)

FacilityCityRegionStatus
Hospitalisation à domicile de la région de Melun Vaux-le-Pénil France Not Yet Recruiting
Hôpital Henri Mondor Créteil France Recruiting
Hôpital Henri Mondor Créteil France Not Yet Recruiting
Hospitalisation à domicile Fondation Santé Service Levallois-Perret France Not Yet Recruiting
Hospitalisation à Domicile AP-HP Paris France Recruiting
Institut Curie Paris France Recruiting
Hôpital Sainte Périne Paris France Active Not Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05685628 on ClinicalTrials.gov ↗ ← All trials in France