Oral Care Interventions in PEG-Fed Palliative Care Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Yalova
About this trial
This pilot randomized controlled trial will compare three oral care interventions in adult palliative care patients who receive enteral nutrition through a percutaneous endoscopic gastrostomy (PEG) tube. The purpose of the study is to determine how these oral care interventions affect the health and integrity of the oral mucosa.
Participants will be randomly assigned to one of three groups: oral care with Ankaferd Hemostat, benzydamine hydrochloride, or a combined solution containing methylprednisolone, ceftriaxone, and sodium bicarbonate. Oral care will be provided by trained nurses according to a standardized protocol.
Participants' mouths will be assessed at the beginning of the study and on days 7 and 15. These assessments will include examination of the oral mucosa and standardized photographs of the mouth. Relevant clinical and laboratory information available as part of routine patient care will also be recorded. The findings will be used to compare changes in oral mucosal health among the three groups.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Ankaferd Hemostat
DrugAnkaferd Hemostat will be used as a topical oral care intervention. For each application, 1 mL of Ankaferd Hemostat will be mixed with 4 mL of sterile water to obtain a total volume of 5 mL. The prepared solution will be applied to the oral mucosal surfaces by a trained nurse twice daily, approximately 12 hours apart, for 15 days. The solution will not be swallowed.
Benzydamine Hydrochloride 0.15% w/v oromucosal solution
DrugBenzydamine hydrochloride 0.15% will be used as a topical oral care intervention. The solution will be applied to the oral mucosal surfaces by trained nurses twice daily for 15 days. Because participants receive enteral nutrition through PEG and may have an increased risk of aspiration, the solution will not be used as a gargle and will not be swallowed.
Combined Oral Care Solution
DrugA combined oral care solution containing 40 mg methylprednisolone, 1000 mg ceftriaxone, and 0.84 g sodium bicarbonate will be used as a topical oral care intervention. Ceftriaxone will be diluted with 10 mL normal saline, methylprednisolone with 5 mL normal saline, and sodium bicarbonate will be added to obtain a final volume of 25 mL. The prepared solution will be applied to the oral mucosal surfaces by trained nurses twice daily, approximately 12 hours apart, for 15 days. The solution will not be swallowed.
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Arm 1 - Ankaferd HemostatExperimental treatment 1 intervention
Group B: Arm 2 - Benzydamine HydrochlorideExperimental treatment 1 intervention
Group C: Arm 3 - Combined Oral Care SolutionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Oral Mucositis Assessment Scale (OMAS) Score
Oral mucosal integrity will be assessed using the Oral Mucositis Assessment Scale (OMAS), which evaluates ulceration/pseudomembrane and erythema at predefined oral sites. Ulceration is scored from 0 to 3 and erythema from 0 to 2, with higher scores indicating greater oral mucosal damage.
Time frame
Baseline (Day 0), Day 7, and Day 15Locations
Sponsors and contacts
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University of Yalova
Lead sponsor
Yalova training and research hospital
Collaborator
Source ClinicalTrials.gov
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