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

Study Overview
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Brief Summary
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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 3 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 SEFI® scale. Day 14 only: Wound-Qol scale and self-questionnaire on the appearance of any discomfort(s)/reaction(s) due to the dressing.

Detailed Description
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Refer to Brief summary.

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

Conditions
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Malodorous Wounds (Chronic, Malignant or Infected Wounds)

Intervention / Treatment
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* Other: Cinnamon dressing
* Other: Charcoal dressing


Participation Criteria
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Eligibility Criteria
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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); Effective contraception for the duration of the research for fertile women of childbearing age 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cinnamon dressing group<br>Use of the cinnamon dressing for 14 days | Other: Cinnamon dressing<br>* 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.<br>|
| Active Comparator: Charcoal dressing Group<br>Use of the charcoal dressing for 14 days | Other: Charcoal dressing<br>* Use of ACTISORB® as a non-occlusive secondary dressing CE marked medical device class IIb, without adhesive, consisting of a non-woven nylon envelope containing a layer of activated carbon. ACTISORB® can be applied as a primary or secondary dressing.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malodorous wounds, Malignant wound, Symptom management