CIN-PMS-UK Version n° 1.0 – 04/07/2022
Research type
Research Study
Full title
Controlling malodour in fungating wounds using a cinnamon-based dressing: Observational study
IRAS ID
316042
Contact name
Fania Pagnamenta
Contact email
Sponsor organisation
CEMAG Care
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 10 months, 0 days
Research summary
There are several anti-odour treatments on the market for managing malodorous wounds but no conclusive data on their efficacy is available. Current treatments like charcoal dressing or topical antimicrobials do not completely manage bad odours in particular for tumoral wounds.
In the case of malodorous wounds, the ideal management plan would therefore be to reduce (or neutralise) bad odours, and modify any residual odour so that it becomes more pleasant than unpleasant.
Cinesteam® was specially developed to reduce and manage malodorous wounds. Cinesteam® is a secondary dressing that eliminates unpleasant odours and masks any residual odours with the spice’s natural fragrance. Cinesteam® also absorbs excess exudates released by the wound.
The aim of this post-market observational study is to observe the performance of Cinesteam® in controlling malodour in fungating wounds. Patients with malodourous, fungating wounds, above 18 years with a discomfort score of >40/100, with cognitive ability to participate and consent, will be eligible to participate in the study. The study will be conducted on eligible patients in the North East of England, treated at the Newcastle upon Tyne Hospitals NHS Foundation Trust, either as inpatients or in its surrounding community.
The duration of patient participation in the study is 14 days. The research nurse will visit patients on Day0 and perform wound assessment, apply Cinesteam dressing over the standard care primary dressing and answer questionnaires on odour, and discomfort, and also help patients with questionnaires on odour, discomfort, appetite and Quality of life. The research nurse will change Cinesteam dressing on Day 1, Day 7 +/- 48 hours, and Day 14 +/- 48 hours and perform follow-up assessments on patients' wound condition. Patients or their caregivers who usually change the patient’s dressing will change the primary dressing and Cinesteam dressing in-between the research nurse’s assessment visits. They will keep a record of these dressing changes in the diary provided.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
22/EE/0210
Date of REC Opinion
21 Oct 2022
REC opinion
Further Information Favourable Opinion