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临床试验/NCT07531472
NCT07531472尚未招募不适用

Outcome of Hyaluronic Acid Gel Versus Petroleum Jelly in Treatment of Epistaxis

Assiut University0 个研究点目标入组 50 人开始时间: 2026年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
主要终点
To compare the recurrence rate of epistaxis between the two groups

研究概览

简要总结

The aim of this study is to compare the efficacy of Hyaluronic Acid Gel with Petroleum Jelly in treatment of epistaxis.

详细描述

  • Epistaxis is one of the most common otorhinolaryngologic emergencies. It affects up to 60% of the population during their lifetime, with 6% requiring medical attention. The greatest peaks in the overall incidence occur in individuals under 10 years of age and over 40 years of age.
  • In 1879, James Little identified an arterial plexus on the anterior septum as a frequent site of bleeding and the same plexus was described one year later by Kiesselbach. As a result of these descriptions, the area most frequently implicated in epistaxis is known as Little's area or Kiesselbach plexus which is anatomically formed by the anastomosis between the terminal branches of the external and internal carotid arteries (Anterior ethmoidal artery, Septal branch of Superior labial artery, Septal branch of Sphenopalatine artery, Septal branch of Greater palatine artery) .
  • The most common etiology of epistaxis is idiopathic in 80%-90% of cases, no precipitating causes can be identified. Of the other identifiable local causes of epistaxis, the most frequent are trauma, nasal neoplasm, iatrogenic or due to systemic factors (hypertension, coagulopathy, inflammatory conditions, infectious diseases, vessel wall fibrosis in associated with ageing), use of drugs (anticoagulant, antiplatelet, nonsteroidal anti-inflammatory nasal sprays) and congenital nasal septal abnormalities .
  • Management of recurrent anterior epistaxis can be done by cautery (chemical or electrical), anterior nasal packing or Surgical therapy if the other methods failed .
  • This protocol outlines standardized guidelines for the use of Hyaluronic Acid (HA) in epistaxis management for nasal mucosal hydration, healing, and recurrence prevention. It is suitable for use in ENT clinics, emergency departments, and hospital wards.
  • Mechanism of action of Hyaluronic acid:
  1. Hydration: Binds large amounts of water, maintaining skin moisture and elasticity.
  2. Wound healing: Promotes keratinocyte and fibroblast proliferation, enhancing tissue repair and regeneration.
  3. Anti-inflammatory effect: Reduces inflammatory cytokines and modulates immune response.
  4. Barrier protection: Forms a protective layer that prevents water loss and protects against irritants and microbes.
  5. Collagen stimulation: Supports collagen synthesis and improves skin structure.
  6. Antioxidant action: Scavenges free radicals, reducing oxidative damage.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

"This is an open-label study; both participants and investigators will be aware of the assigned treatment (Hyaluronic Acid Gel or Petroleum Jelly) due to the nature of the interventions."

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with anterior localized idiopathic epistaxis

排除标准

  • Patients wit secondary epistaxis (posttraumatic, postoperative, tumoral).
  • During pregnancy.
  • Patients wit major systemic disease (Blood Disease, Hypertension).

研究组 & 干预措施

Hyaluronic Acid Gel

Experimental

"Participants in this group will receive topical hyaluronic acid gel applied to the nasal mucosa for the treatment of epistaxis. The application will be done as per the study protocol, and outcomes will be monitored over the study period."

干预措施: Hyaluronic Acid Gel (Drug)

Petroleum Jelly

Experimental

"Participants in this group will receive topical petroleum jelly applied to the nasal mucosa for the treatment of epistaxis. The application will follow the study protocol, and outcomes will be monitored over the study period."

干预措施: Petroleum jelly (Drug)

结局指标

主要结局

To compare the recurrence rate of epistaxis between the two groups

时间窗: 14 days

"Proportion of participants whose epistaxis stops completely within 7 days of treatment application."

次要结局

  • To assess time to symptom resolution(Within 24 hours)
  • To evaluate mucosal healing (endoscopic findings)(7-14 days)
  • To assess patient comfort and compliance(7 days)
  • To record adverse effects(14 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marina Emil Kamal Kaml

Otolaryngology Resident

Assiut University

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