WoundOdourNCT04669626
The Ability of Octenilin® to Reduce Odour of Malodorous Wound
A study testing Use of Ocetnilin and Use of NaCl 0.9% in people with Wound and Wound Heal, run by School of Health Sciences Geneva at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound, Wound Heal
- What is being tested?
- Use of Ocetnilin and Use of NaCl 0.9%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2020to 22 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A chronic malodourous wound
- Age over 18 years
- Proficiency in the French language
Who cannot join
- Valid informed consent is not or cannot be given
- Patients needing dressings with Silver
- Patients needing charcoal dressings
- Patients under antibiotic treatment
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Cité Génération Maison de santé
Onex, Canton of Geneva, 1213
About this study
Official title: The Ability of Octenilin® to Reduce Odour of Malodorous Wound - a Single-center Randomized Double Blinded Controlled Pilot Study
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).
Read the 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).
- Conditions
- Wound, Wound Heal
- Being tested
- Use of Ocetnilin, Use of NaCl 0.9%
- Keywords
- Odour, wound care
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of OcetnilinOther
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)
Use of NaCl 0.9%Other
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)
| Study group | Role | What they receive |
|---|---|---|
| Group 2 | Other | Wound cleansing with NaCl (natrium chlorid) solution 0.9% Receives: Other: Use of NaCl 0.9% |
| Group 1 | Experimental | Wound cleansing with Octenilin® Receives: Other: Use of Ocetnilin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start1 Jul 2020
- Primary completion30 Nov 2021
- Study completion22 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- School of Health Sciences Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sebastian Probst, Prof Dr, Principal investigator, HES-SO University of Applied Sciences and Arts Western Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04669626
- Sponsor's protocol ID
- Odour
- Acronym
- Odour
- Status last verified
- May 2022
- First submitted
- 9 Dec 2020
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data will be ananymised
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Ability of Octenilin® to Reduce Odour of Malodorous Wound - a Single-center Randomized Double Blinded Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT04669626
- Acronym / sponsor ID
- Odour / Odour
- Conditions
- Wound, Wound Heal
- Keywords
- Odour, wound care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- School of Health Sciences GenevaUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 22 Dec 2021 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 2 | Other | Other: Use of NaCl 0.9%Wound cleansing with NaCl (natrium chlorid) solution 0.9% |
| Group 1 | Experimental | Other: Use of OcetnilinWound cleansing with Octenilin® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A chronic malodourous wound
- Age over 18 years
- Proficiency in the French language
Key exclusion criteria (4 listed)
- Valid informed consent is not or cannot be given
- Patients needing dressings with Silver
- Patients needing charcoal dressings
- Patients under antibiotic treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of OcetnilinVisits 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) | Other | Group 1 |
| Use of NaCl 0.9%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) | Other | Group 2 |
Primary outcome
Assessment of wound odour
Time frame: 12 weeks
assessment of wound odour intensity by the study nurse using a Visual Analog Scale (VAS) from 0 to 100 (perceived odour).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Individual participant dataSharing planned: No. data will be ananymised
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastian Probst, Prof Dr principal investigator
HES-SO University of Applied Sciences and Arts Western Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of Ocetnilin and Use of NaCl 0.9% in people with Wound and Wound Heal, run by School of Health Sciences Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of wound odour (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022.