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Completed

NCT Number: NCT04669626

The Ability of Octenilin® to Reduce Odour of Malodorous Wound

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cité Génération Maison de santé

Onex, Canton of Geneva, 1213, Switzerland

About this 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. 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Use of Ocetnilin

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 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)

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

School of Health Sciences Geneva

Other

Registry information

Official study title

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

Acronym: Odour

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 17, 2020
Registry last updated
May 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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