The Ability of Octenilin® to Reduce Odour of Malodorous Wound

Study Overview
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Brief Summary
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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
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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).

Official Title
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The Ability of Octenilin® to Reduce Odour of Malodorous Wound - a Single-center Randomized Double Blinded Controlled Pilot Study

Conditions
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Wound, Wound Heal

Intervention / Treatment
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* Other: Use of Ocetnilin
* Other: Use of NaCl 0.9%


Participation Criteria
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Eligibility Criteria
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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

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group 2<br>Wound cleansing with NaCl (natrium chlorid) solution 0.9% | Other: Use of NaCl 0.9%<br>* 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)<br>|
| Experimental: Group 1<br>Wound cleansing with Octenilin® | Other: Use of Ocetnilin<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Odour, wound care