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

Primary Purpose

Malodorous Wounds (Chronic, Malignant or Infected Wounds)

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cinnamon dressing
Charcoal dressing
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malodorous Wounds (Chronic, Malignant or Infected Wounds) focused on measuring Malodorous wounds, Malignant wound, Symptom management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Assistance Publique Hôpitaux de Paris - CHU Henri Mondor
  • Institut Curie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cinnamon dressing group

Charcoal dressing Group

Arm Description

Use of the cinnamon dressing for 14 days

Use of the charcoal dressing for 14 days

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Odor discomfort / patient
Discomfort related to the smell felt in the last 24 hours (from 0 to 10) assessed by the patient.
Odor discomfort / nurse
Discomfort related to the smell felt (from 0 to 10) assessed by the nurse performing the treatment
Odor discomfort / family
Discomfort related to the smell felt (from 0 to 10) assessed by the family present (if it's practical)
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
Odor discomfort / patient
Discomfort related to the smell felt (from 0 to 10) assessed by the patient just before the first dressing change
Cutaneous reaction or dressing discomfort
Patient's questionnaire
Dressing qualities
Nurse's questionnaire: dressing flexibility, application, opening

Full Information

First Posted
December 7, 2022
Last Updated
March 27, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT05685628
Brief Title
Evaluation of the Quality of Life Induced by the Cinnamon Anti-odor Dressing in Patients With Malodorous Wounds
Acronym
CINNAMON
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 28, 2023 (Anticipated)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
Refer to "Brief summary".

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malodorous Wounds (Chronic, Malignant or Infected Wounds)
Keywords
Malodorous wounds, Malignant wound, Symptom management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cinnamon dressing group
Arm Type
Experimental
Arm Description
Use of the cinnamon dressing for 14 days
Arm Title
Charcoal dressing Group
Arm Type
Active Comparator
Arm Description
Use of the charcoal dressing for 14 days
Intervention Type
Other
Intervention Name(s)
Cinnamon dressing
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Charcoal dressing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Wound-Qol
Description
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.
Time Frame
Day 0 and 14
Secondary Outcome Measure Information:
Title
Odor discomfort / patient
Description
Discomfort related to the smell felt in the last 24 hours (from 0 to 10) assessed by the patient.
Time Frame
Day 0, 7 and 14.
Title
Odor discomfort / nurse
Description
Discomfort related to the smell felt (from 0 to 10) assessed by the nurse performing the treatment
Time Frame
Day 0, 7 and 14.
Title
Odor discomfort / family
Description
Discomfort related to the smell felt (from 0 to 10) assessed by the family present (if it's practical)
Time Frame
Day 0, 7 and 14.
Title
SEFI® Scale to assess appetite
Description
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
Time Frame
Day 0, 7 and 14.
Title
Odor discomfort / patient
Description
Discomfort related to the smell felt (from 0 to 10) assessed by the patient just before the first dressing change
Time Frame
Day 1
Title
Cutaneous reaction or dressing discomfort
Description
Patient's questionnaire
Time Frame
Day 14
Title
Dressing qualities
Description
Nurse's questionnaire: dressing flexibility, application, opening
Time Frame
Day 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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); 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fatoumata NIAKATE, IDE
Phone
+33 6 67 16 04 46
Email
fatoumata.niakate@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatoumata NIAKATE, IDE
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique Hôpitaux de Paris - CHU Henri Mondor
City
Créteil
ZIP/Postal Code
94 010
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fatoumata NIAKATE, IDE
Phone
+33 6 67 16 04 46
Email
fatoumata.niakate@aphp.fr
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75 005
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data are own by Assistance Publique - Hôpitaux de Paris, please contact sponsor for further information.

Learn more about this trial

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

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