Oral Care Interventions in PEG-Fed Palliative Care Patients

N/ANot Yet RecruitingNCT07792473

University of Yalova60 enrolled

Overview

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.

Patients receiving enteral nutrition through a percutaneous endoscopic gastrostomy (PEG) tube may experience oral health problems because of reduced oral intake, underlying disease, functional limitations, and dependence on oral care. Maintaining oral mucosal integrity is therefore an important component of nursing care in palliative care settings. This pilot study will evaluate and compare three oral care interventions used in clinical practice in PEG-fed palliative care patients. The study will focus on changes in oral mucosal integrity, including erythema and ulceration. The findings will provide preliminary information on the effects of these interventions and may help inform the design of a future larger randomized controlled trial.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Interventions

Ankaferd HemostatDRUG

Ankaferd 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 solutionDRUG

Benzydamine 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 SolutionDRUG

A 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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Aged 18 years or older Hospitalized in the palliative care unit Receiving enteral nutrition via percutaneous endoscopic gastrostomy (PEG) and expected to continue PEG feeding during the study follow-up period Able to undergo baseline oral cavity assessment No clinical condition preventing the planned oral care intervention No known allergy or hypersensitivity to the components of the assigned oral care intervention Written informed consent provided by the patient or legally authorized representative Exclusion Criteria: Active severe bleeding in the oral cavity Extensive traumatic or surgical lesions in the oral cavity that prevent implementation of the oral care intervention Severe oral mucositis or oral tissue necrosis that prevents implementation of the intervention Uncontrolled bleeding risk or clinically significant coagulopathy Terminal agitation or clinical instability that prevents safe implementation of oral care Development of a clinical condition during follow-up that requires discontinuation of the assigned oral care intervention

Outcomes

Primary Outcomes

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 15