Controlling Malodour In Fungating Wounds Using A Cinnamon-Based Dressing: Observational Study

NCT05650762 | Unknown

• 1 other identifier: CIN-S22001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to observe the contribution of the cinnamon dressing to the reduction of the discomfort associated with the odour felt by the patient and carers. This prospective study aims to collect data on patients living with a malodorous fungating wound. Quality of life tools will be used to assess the impact of the cinnamon dressing on managing malodorous fungating wounds.

Conditions

Wound

Keywords

Malodorous wound; Quality of life; Patient and Investigator discomfort

Outcome Measures

Primary Outcomes (1)

• Change from baseline patient wound odour at different timepoints using a Visual Analogue Scale (VAS-100mm scale), from 0 (no smell) to 100 (worst smell imaginable)

  Baseline visit, one day, 7 and 14 days after baseline visit

Secondary Outcomes (3)

• Change from baseline patient discomfort associated with the wound odour at different timepoints using a Visual Analogue Scale (VAS-100mm scale), from 0 (no discomfort) to 100 (Unbearable discomfort during the sleeping and waking hours)

  Baseline visit, one day, 7 and 14 days after baseline visit

• Change from baseline patient quality of life at different timepoints using the questionnaire of EuroQol 5 Dimension 5 Level (EQ-5D-5L)

  Baseline visit, one day and 14 days after baseline visit

• Change from baseline investigator-rating the strength of the wound odour and smell at different timepoints using TELERTM from none odour to very strong odour.

  Baseline visit, one day, 7 and 14 days after baseline visit

Study Arms (1)

Cinnamon

EXPERIMENTAL

Device: Cinesteam

Interventions

Cinesteam DEVICE

Cinnamon-based Secondary dressing

Cinnamon

Eligibility Criteria

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

You may qualify if:

• Patient \> 18 years old with malodorous fungating wounds
• Discomfort \> 40/100 expressed by the patient);
• Patients who have capacity to consent;
• Patients who are cognitively able and willing to participate;
• Patients who have a good command of the English language.

You may not qualify if:

• Patient with pressure ulcers, leg ulcers, diabetic feet ulcers;
• Terminally ill patients whose life expectancy is less than the duration of the protocol;
• Patients having had metronidazole treatment for fewer than 3 days before enrolment in the study;
• Patients who are unable or willing to participate;
• Anosmic patient (with no sense of smell);
• Patient with cinnamon allergy;
• Persons deprived of their liberty or under guardianship;
• Unable to take part in study procedures for whatever reason;
• Pregnant or lactating women.

Sponsors & Collaborators

• CEMAG Care: lead

Study Sites (1)

The Newcastle upon Tyne Hospital NHS Foundation Trust

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 14, 2022
• Study Start: February 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: October 1, 2023
• Last Updated: December 14, 2022

Record last verified: 2022-12

Locations

GB (1)