A prospective non-randomized controlled study of vaseline-medicated gauze for topical management of chemotherapy-induced oral mucositis in pediatric hematology patients

Abstract

Abstract Background: Chemotherapy-induced oral mucositis (CIOM) is a severe complication in pediatric hematologic malignancies, leading to treatment interruptions and increased infection risk. Current interventions demonstrate prolonged healing times. This study evaluated the efficacy of Vaseline gauze loaded with a compound powder for improving CIOM healing and pain control，guided by mucosal barrier theory and a multi-target anti-infection strategy. Methods: Sixty pediatric patients (aged 2-12 years) with grade ≥2 CIOM (WHO Oral Toxicity Scale) following high-dose chemotherapy (February 2024 - February 2025) were enrolled in this prospective non-randomized controlled trial. Intervention group (n=40): Applied innovative drug-loaded gauze containing [X antibiotics + X vitamins + X antivirals]. We trimmed the gauze to match ulcer morphology with 2-mm peripheral extension, ensuring complete ulcer coverage before sterile-forceps positioning (twice daily; according to Olive et al.‘s standardized pediatric protocol). Control group (n=20): Received conventional 1.5% sodium bicarbonate mouth rinse (4 times/day post-meals/bedtime, ≥2 minutes per rinse; evidence from Saha et al.‘s systematic review).Primary outcome is Time to mucosal healing (WHO grade 0 sustained).Secondary outcomes are Pain score reduction (Wong-Baker FACES Scale) at 48h post-intervention and safety events. Kaplan-Meier analysis compared group differences with Cox regression. Results: The baseline characteristics of the two groups were comparable, with no statistically significant differences observed (all p > 0.05). In terms of mucosal healing outcomes, the medicated gauze group demonstrated a median healing time of 3 days (interquartile range [IQR], 2–5 days), which corresponding to a 57% reduction compared to the control group (median, 7 days; IQR, 6–8 days). This difference in healing time between the medicated gauze group and the control group was statistically significant (Log-rank test, p < 0.001). Furthermore, the healing efficacy of the medicated gauze surpassed the benchmarks reported in existing literature, such as those for honey (median, 4 days; IQR, 4–6 days) and olive oil (median, 6 days; IQR, 5–7 days), and representing a 25% improvement over the best-performing existing intervention (honey therapy, 4 days). At 48 hours post-intervention, the mean reduction in pain scores was 4.8 ± 0.9 points in the intervention group, compared with a significantly smaller reduction of 2.1 ± 1.0 points in the control group (p = 0.002), with a 128% greater pain score reduction. No treatment-related adverse events, including allergic reactions or secondary infections, were reported in either group. Regarding procedure adherence, the intervention group achieved a high rate of 93.5%, which was significantly higher than the 67.7% adherence rate observed in the control group（p＜0.01）. Conclusions: The Vaseline-medicated gauze external application significantly accelerates healing progression in pediatric chemotherapy-induced oral mucositis (CIOM), while substantially enhancing early-phase pain alleviation rates within the critical 48-hour window. This intervention demonstrates uncompromised safety and exceptional procedural adherence throughout the treatment cycle, establishing an integrated clinical management protocol for pediatric hematology patients undergoing high-intensity chemotherapy that unifies high-efficacy mucosal repair, expedited symptomatic resolution, and streamlined care administration.