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Oral Care Interventions in PEG-Fed Palliative Care Patients (PEG-ORAL)

27 augusti 2026 uppdaterad av: Yasemin Karacan, University of Yalova

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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

60

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Läkemedel: Ankaferd Hemostat
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.
Experimentell: 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.
Läkemedel: Benzydamine Hydrochloride 0.15% w/v oromucosal solution
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.
Experimentell: 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.
Läkemedel: Combined Oral Care Solution
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Oral Mucositis Assessment Scale (OMAS) Score
Tidsram: Baseline (Day 0), Day 7, and Day 15
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.
Baseline (Day 0), Day 7, and Day 15

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Yalova

Samarbetspartners

Yalova training and research hospital

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

  • 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.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

7 september 2026

Primärt slutförande (Beräknad)

1 februari 2027

Avslutad studie (Beräknad)

1 mars 2027

Studieregistreringsdatum

Först inskickad

25 augusti 2026

Först inskickad som uppfyllde QC-kriterierna

25 augusti 2026

Första postat (Faktisk)

28 augusti 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

1 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

27 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • YKU-PEG-ORALCARE-2026-01

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

De-identified individual participant data underlying the results reported in the published article may be shared with qualified researchers upon reasonable request to the corresponding author and following approval of the proposed research purpose. Data will be shared in accordance with applicable ethical and institutional requirements.

Tidsram för IPD-delning

Beginning 6 months after publication of the study results and available for 5 years.

Kriterier för IPD Sharing Access

De-identified individual participant data and supporting information will be available to qualified researchers who submit a methodologically sound research proposal. Requests should be submitted to the corresponding author and will be reviewed by the research team. Access will be granted for approved research purposes and in accordance with applicable ethical and institutional requirements.

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV

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