Oral Care Interventions in PEG-Fed Palliative Care Patients (PEG-ORAL)
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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Yasemin Karacan, PhD
- Número de teléfono: 05327141814
- Correo electrónico: jblacksoul@yahoo.com
Copia de seguridad de contactos de estudio
- Nombre: Irem Ozturk Bardak, RN
- Correo electrónico: irem.ozturk@yalova.edu.tr
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Arm 1 - Ankaferd Hemostat
Arm 1 - Ankaferd Hemostat Participants assigned to this arm will receive standardized oral care followed by topical application of Ankaferd Hemostat.
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 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.
|
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.
|
|
Experimental: Arm 2 - Benzydamine Hydrochloride
Arm 2 - Benzydamine Hydrochloride Participants assigned to this arm will receive standardized oral care followed by topical application of 0.15% benzydamine hydrochloride.
The solution will be applied to the oral mucosal surfaces by trained nurses twice daily for 15 days.
Because participants are fed through PEG and may have an increased risk of aspiration, the solution will not be used as a gargle and will not be swallowed.
|
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.
|
|
Experimental: Arm 3 - Combined Oral Care Solution
Arm 3 - Combined Oral Care Solution Participants assigned to this arm will receive standardized oral care followed by topical application of a combined solution containing 40 mg methylprednisolone, 1000 mg ceftriaxone, and 0.84 g sodium bicarbonate.
The final solution volume will be 25 mL and will be prepared with normal saline according to the standardized clinical preparation procedure.
The 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.
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Oral Mucositis Assessment Scale (OMAS) Score
Periodo de tiempo: Baseline (Day 0), Day 7, and Day 15
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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.
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Baseline (Day 0), Day 7, and Day 15
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Publicaciones Generales
- Sonis ST, Eilers JP, Epstein JB, et al. Validation of a new scoring system for the assessment of clinical trial research of oral mucositis induced by radiation or chemotherapy. Cancer. 1999;85(10):2103-2113. PMID: 10326686 Epstein JB, Silverman S Jr, Paggiarino DA, et al. Benzydamine HCl for prophylaxis of radiation-induced oral mucositis: results from a multicenter, randomized, double-blind, placebo-controlled clinical trial. Cancer. 2001;92(4):875-885. PMID: 11550161 Puhar I, Paleško Tubikanec T, Glavina S, et al. Effect of Benzydamine Hydrochloride on Dental Plaque Accumulation During Short-Term Restricted Oral Hygiene: A Randomized, Placebo-Controlled Trial. Pharmaceuticals. 2026;19:1013. Berk D, Durna Z, Akın S. Kemoterapi uygulanan kanser hastalarında ağız bakımı uygulamaları ve ağız bakım alışkanlıklarının değerlendirilmesi. Sağlık ve Toplum. 2020;30(2):54-63. Kasnak G, Fıratlı HE. Antimikrobik gargara kullanımının ağız mikrobiyotasına etkisi. In: Altındiş M, ed. Ağız Mikrobiyotası. İstanbul: Nobel Yayın Dağıtım; 2022:263-287. Dağyar K. Oral Mukoza Hastalıklarının Tedavisinde Kortikosteroid Kullanımı. Bitirme Tezi. İstanbul Üniversitesi Diş Hekimliği Fakültesi; 2021.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- YKU-PEG-ORALCARE-2026-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
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