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

Evaluation of the Quality of Life Induced by the Cinnamon Anti-odor Dressing in Patients With Malodorous Wounds: a Multicenter Randomized Controlled Trial

Refer to "Detailed description".

Study Overview

• Status: Recruiting
• Conditions: Malodorous Wounds (Chronic, Malignant or Infected Wounds)
• Intervention / Treatment: Other: Cinnamon dressing; Other: Charcoal dressing

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.

• Study Type: Interventional
• Enrollment (Estimated): 98
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maxime CHERON, IDE; Phone Number: +33 01 44 32 42 34; Email: maxime.cheron@curie.fr

Study Locations

• France
  • Créteil, France, 94 000
    • Not yet recruiting
    • Hopital Henri Mondor
    • Contact: Fannie ARNOULT, IDE; Phone Number: +33 01 49 81 25 16; Email: fannie.arnoult@aphp.fr
  • Créteil, France, 94 000
    • Recruiting
    • Hopital Henri Mondor
    • Contact: Coralie BOITEAU, IDE; Phone Number: +33 01 49 81 21 11; Email: coralie.boiteau@aphp.fr
  • Levallois-Perret, France, 92 300
    • Not yet recruiting
    • Hospitalisation à domicile Fondation Santé Service
    • Contact: Sébastien PERRIGUEY, IDE; Phone Number: +33 01 71 29 00 72; Email: sebastien.perriguey@fondation-santeservice.fr
  • Paris, France, 75 005
    • Recruiting
    • Institut Curie
    • Contact: Marguerite NICODEME, IPA; Phone Number: +33 01 56 24 59 58; Email: marguerite.nicodeme@curie.fr
    • Contact: Maxime CHERON, IDE; Phone Number: +33 01 44 32 42 34; Email: maxime.cheron@curie.fr
  • Paris, France, 75 005
    • Recruiting
    • Hospitalisation à Domicile AP-HP
    • Contact: Isabelle CEDOLIN, IDE; Phone Number: +33 06 23 25 15 34; Email: isabelle.cedolin@aphp.fr
  • Paris, France, 75 016
    • Active, not recruiting
    • Hôpital Sainte Périne
  • France
    • Vaux-le-Pénil, France, France, 77 000
      • Not yet recruiting
      • Hospitalisation à domicile de la région de Melun
      • Contact: Anne-Laure SAVOURÉ; Phone Number: +33 07.61.67.89.13; Email: a.savoure@hadmelun.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cinnamon dressing group; Use of the cinnamon dressing for 14 days	Other: 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.
Active Comparator: Charcoal dressing Group; Use of the charcoal dressing for 14 days	Other: Charcoal dressing; Use of a secondary non-occlusive activated charcoal dressing (brand of your choice)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 0 and 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Odor discomfort / patient	Discomfort related to the smell felt in the last 24 hours (from 0 to 10) assessed by the patient.	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	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)	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	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	Day 1
Cutaneous reaction or dressing discomfort	Patient's questionnaire	Day 14
Dressing qualities	Nurse's questionnaire: dressing flexibility, application, opening	Day 3

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Study Director: Isabelle FROMANTIN, IDE, Institut Curie

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2023
• Primary Completion (Estimated): April 19, 2027
• Study Completion (Estimated): April 19, 2027

Study Registration Dates

• First Submitted: December 7, 2022
• First Submitted That Met QC Criteria: January 12, 2023
• First Posted (Actual): January 17, 2023

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Symptom management; Malodorous wounds; Malignant wound
• Additional Relevant MeSH Terms: Organizing Pneumonia; Immune System Diseases; Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Graft vs Host Disease; Bronchiolitis Obliterans Syndrome; Wound Infection; Physiological Effects of Drugs; Protective Agents; Antidotes; Charcoal
• Other Study ID Numbers: APHP220093

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data are own by Assistance Publique - Hôpitaux de Paris, please contact sponsor for further information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No