The Ability of Octenilin® to Reduce Odour of Malodorous Wound (Odour)
Primary Purpose
Wound, Wound Heal
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Use of Ocetnilin
Use of NaCl 0.9%
Sponsored by
About this trial
This is an interventional treatment trial for Wound focused on measuring Odour, wound care
Eligibility Criteria
Inclusion Criteria:
- A chronic malodourous wound
- Age over 18 years
- Proficiency in the French language
Exclusion Criteria:
- Valid informed consent is not or cannot be given
- Patients needing dressings with Silver
- Patients needing charcoal dressings
- Patients under antibiotic treatment
Sites / Locations
- Cité Génération Maison de santé
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Group 2
Group 1
Arm Description
Wound cleansing with NaCl (natrium chlorid) solution 0.9%
Wound cleansing with Octenilin®
Outcomes
Primary Outcome Measures
Assessment of wound odour
assessment of wound odour intensity by the study nurse using a Visual Analog Scale (VAS) from 0 to 100 (perceived odour).
Secondary Outcome Measures
Full Information
NCT ID
NCT04669626
First Posted
December 9, 2020
Last Updated
May 10, 2022
Sponsor
School of Health Sciences Geneva
1. Study Identification
Unique Protocol Identification Number
NCT04669626
Brief Title
The Ability of Octenilin® to Reduce Odour of Malodorous Wound
Acronym
Odour
Official Title
The Ability of Octenilin® to Reduce Odour of Malodorous Wound - a Single-center Randomized Double Blinded Controlled Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
December 22, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
School of Health Sciences Geneva
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Malodours are a common complication of chronic wounds. They are the result of the proliferation of aerobic and anaerobic micro-organisms on the wound surface, where they metabolize healthy tissue which leads to the production of sloughy and even necrotic tissue. Wound odour has a big impact on the quality of life of patients.
Currently the standard of care for the management of malodourous wounds are systemic antibiotics, absorbent wound dressings with or without activated carbon and, topical antimicrobials. The application of topical antimicrobials such as antiseptics against wound odour is part of the standard care. One suggested antiseptic in a recent published standard is Octenilin®. There is ample anecdotal evidence about the efficacy of Octenilin® in reducing wound odour. Therefore, we propose here to document this ability by evaluating the odour of wounds washed with Octenilin® versus standard care (NaCl 0.9% solution).
Detailed Description
Malodours are a common complication of chronic wounds. They are the result of the proliferation of aerobic and anaerobic micro-organisms on the wound surface, where they metabolize healthy tissue which leads to the production of sloughy and even necrotic tissue. Wound odour has a big impact on the quality of life of patients. Patients describe living with a chronic malodourous wound as devastating particularly in respect to social interaction. The key to addressing the negative consequences of malodorous and/or discharging wounds is an effective wound managements plan based on accurate and holistic assessment of the patient and the wound.
Currently the standard of care for the management of malodourous wounds are systemic antibiotics, absorbent wound dressings with or without activated carbon and, topical antimicrobials. The application of topical antimicrobials such as antiseptics against wound odour is part of the standard care. One suggested antiseptic in a recent published standard is Octenilin®. Octenilin® wound cleansing solution is on the Swiss market since 2006 and is routinely used in outpatient wound care centers. It exhibits good performance in the reduction of biofilm's pathogens and has excellent moisturizing properties. While there is ample anecdotal evidence about the efficacy of Octenilin® in reducing wound odour, we propose here to document this ability by evaluating the odour of wounds washed with Octenilin® versus standard care (NaCl 0.9% solution).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound, Wound Heal
Keywords
Odour, wound care
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 2
Arm Type
Other
Arm Description
Wound cleansing with NaCl (natrium chlorid) solution 0.9%
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Wound cleansing with Octenilin®
Intervention Type
Other
Intervention Name(s)
Use of Ocetnilin
Intervention Description
Visits to the outpatient wound-care centre as directed by a physician. Wound care performed by the respective study nurse according to the study-protocol. Each dressing change will be the same and will be as follows:
Removal of old dressing
Applying a soaked gaze with Octenilin® on the wound (5 minutes)
Mechanical debridement if necessary
Wound cleansing with Octenilin®
Application of new dressing (according to the wound healing phases, medical prescription)
Intervention Type
Other
Intervention Name(s)
Use of NaCl 0.9%
Intervention Description
Visits to the outpatient wound-care centre as directed by a physician. Wound care performed by the respective study nurse according to the study-protocol. Each dressing change will be the same and will be as follows:
Removal of old dressing
Applying a soaked gaze with NaCl 0.9% solution on the wound (5 minutes)
Mechanical debridement if necessary
Wound cleansing with NaCl 0.9% solution
Application of new dressing (according to the wound healing phases, medical prescription)
Primary Outcome Measure Information:
Title
Assessment of wound odour
Description
assessment of wound odour intensity by the study nurse using a Visual Analog Scale (VAS) from 0 to 100 (perceived odour).
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A chronic malodourous wound
Age over 18 years
Proficiency in the French language
Exclusion Criteria:
Valid informed consent is not or cannot be given
Patients needing dressings with Silver
Patients needing charcoal dressings
Patients under antibiotic treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastian Probst, Prof Dr
Organizational Affiliation
HES-SO University of Applied Sciences and Arts Western Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cité Génération Maison de santé
City
Onex
State/Province
GE
ZIP/Postal Code
1213
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
data will be ananymised
Learn more about this trial
The Ability of Octenilin® to Reduce Odour of Malodorous Wound
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