The Ability of Octenilin® to Reduce Odour of Malodorous Wound

NCT ID: NCT04669626

Last Updated: 2022-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2021-12-22

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).

Conditions

Wound; Wound Heal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group 2

Wound cleansing with NaCl (natrium chlorid) solution 0.9%

Group Type: OTHER

Use of NaCl 0.9%

Intervention Type: 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)

Group 1

Wound cleansing with Octenilin®

Group Type: EXPERIMENTAL

Use of Ocetnilin

Intervention Type: 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)

Interventions

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)

Intervention Type: OTHER

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)

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

School of Health Sciences Geneva

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sebastian Probst, Prof Dr

Role: PRINCIPAL_INVESTIGATOR

HES-SO University of Applied Sciences and Arts Western Switzerland

Locations

Cité Génération Maison de santé

Onex, Canton of Geneva, Switzerland

Countries

Switzerland

Other Identifiers

Odour

Identifier Type: -

Identifier Source: org_study_id