Viewing Study NCT04669626



Ignite Creation Date: 2024-05-06 @ 3:33 PM
Last Modification Date: 2024-10-26 @ 1:51 PM
Study NCT ID: NCT04669626
Status: COMPLETED
Last Update Posted: 2022-05-11
First Post: 2020-12-09

Brief Title: The Ability of Octenilin to Reduce Odour of Malodorous Wound
Sponsor: School of Health Sciences Geneva
Organization: School of Health Sciences Geneva

Study Overview

Official Title: The Ability of Octenilin to Reduce Odour of Malodorous Wound - a Single-center Randomized Double Blinded Controlled Pilot Study
Status: COMPLETED
Status Verified Date: 2022-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: Odour
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 09 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 andor 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 biofilms 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 09 solution

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None