The Ability of Octenilin® to Reduce Odour of Malodorous Wound

NCT04669626 | Completed DMC

• 1 other identifier: Odour
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Wound; Wound Heal

Keywords

Odour; wound care

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group 2

OTHER

Wound cleansing with NaCl (natrium chlorid) solution 0.9%

Other: Use of NaCl 0.9%

Group 1

EXPERIMENTAL

Wound cleansing with Octenilin®

Other: Use of Ocetnilin

Interventions

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)

Group 1

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)

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A chronic malodourous wound
• Age over 18 years
• Proficiency in the French language

You may not qualify if:

• Valid informed consent is not or cannot be given
• Patients needing dressings with Silver
• Patients needing charcoal dressings
• Patients under antibiotic treatment

Sponsors & Collaborators

• School of Health Sciences Geneva: lead

Study Sites (1)

Cité Génération Maison de santé

Onex, Canton of Geneva, 1213, Switzerland

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Sebastian Probst, Prof Dr

  HES-SO University of Applied Sciences and Arts Western Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 17, 2020
• Study Start: July 1, 2020
• Primary Completion: November 30, 2021
• Study Completion: December 22, 2021
• Last Updated: May 11, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)