Oral Care Interventions in PEG-Fed Palliative Care Patients

Effects of Oral Care Interventions on Oral Mucosal Integrity in Palliative Care Patients Receiving Enteral Nutrition Via Percutaneous Endoscopic Gastrostomy: A Three-Arm Pilot Randomized Controlled 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.

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.

Inclusion Criteria:

Age 18 years or older. Hospitalized in a palliative care unit. Receiving enteral nutrition via percutaneous endoscopic gastrostomy (PEG). PEG feeding expected to continue throughout the 15-day study period. Able to undergo baseline oral assessment. No clinical condition preventing the application of oral care. No known allergy or hypersensitivity to any component of the study interventions.

Written informed consent provided by the participant or, when the participant lacks decision-making capacity, by a legally authorized representative.

Exclusion Criteria:

Active and severe bleeding in the oral cavity. Extensive traumatic or surgical oral lesions that prevent oral care. Requirement for another therapeutic topical oral antibiotic, corticosteroid, or antiseptic solution at study entry.

Known hypersensitivity to Ankaferd Hemostat, benzydamine hydrochloride, ceftriaxone or other cephalosporins, methylprednisolone, or any other component of the study interventions.

Clinical condition for which the study-related oral care intervention is considered inappropriate by the treating physician.

Terminal condition in which participation or study procedures are considered likely to adversely affect patient comfort.