The Ability of Octenilin® to Reduce Odour of Malodorous Wound

Wound Heal Clinical Trial

— Odour  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04669626
• Other study ID #: Odour
• Status: Completed
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: December 22, 2021

Study information

• Verified date: May 2022
• Source: School of Health Sciences Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 22, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Wound
• Wound Heal
• Wounds and Injuries

Intervention

Other:
• Use of Ocetnilin
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%
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)

Locations

Country	Name	City	State
Switzerland	Cité Génération Maison de santé	Onex	GE

Sponsors (1)

Lead Sponsor	Collaborator
School of Health Sciences Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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