Clinical trial NCT05685628: Evaluation of the Quality of Life Induced by the Cinnamon Anti-odor Dressing in Patients With Malodorous Wounds
Official title: Evaluation of the Quality of Life Induced by the Cinnamon Anti-odor Dressing in Patients With Malodorous Wounds: a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Malodorous Wounds (Chronic, Malignant or Infected Wounds)
Keywords: Malodorous wounds
Malignant wound
Symptom management
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-01-17
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Refer to "Detailed description".

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.

Eligibility criteria: 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 already receiving a secondary charcoal or cinnamon dressing
* 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 outcomes:
measure: Wound-Qol
timeFrame: Day 0 and 14
Secondary outcomes:
measure: Odor discomfort / patient
timeFrame: Day 0, 7 and 14.
measure: Odor discomfort / nurse
timeFrame: Day 0, 7 and 14.
measure: Odor discomfort / family
timeFrame: Day 0, 7 and 14.
measure: SEFI® Scale to assess appetite
timeFrame: Day 0, 7 and 14.
measure: Odor discomfort / patient
timeFrame: Day 1
measure: Cutaneous reaction or dressing discomfort
timeFrame: Day 14
measure: Dressing qualities
timeFrame: Day 3
Other outcomes:
Locations:
city: Créteil
country: France
facility: Hôpital Henri Mondor
city: Créteil
country: France
facility: Hôpital Henri Mondor
city: Levallois-Perret
country: France
facility: Hospitalisation à domicile Fondation Santé Service
city: Paris
country: France
facility: Hospitalisation à Domicile AP-HP
city: Paris
country: France
facility: Institut Curie
city: Paris
country: France
facility: Hôpital Saint Louis
city: Paris
country: France
facility: Hôpital Sainte Périne
Study officials:
affiliation: Institut Curie
name: Isabelle FROMANTIN, IDE
role: STUDY_DIRECTOR
References: