Clinical trial NCT04669626: The Ability of Octenilin® to Reduce Odour of Malodorous Wound
Official title: The Ability of Octenilin® to Reduce Odour of Malodorous Wound - a Single-center Randomized Double Blinded Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound
Wound Heal
Keywords: Odour
wound care
Lead sponsor: School of Health Sciences Geneva
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Assessment of wound odour
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Onex
country: Switzerland
facility: Cité Génération Maison de santé
state: GE
Study officials:
affiliation: HES-SO University of Applied Sciences and Arts Western Switzerland
name: Sebastian Probst, Prof Dr
role: PRINCIPAL_INVESTIGATOR
References: