跳至主要内容
临床试验/NCT06304935
NCT06304935尚未招募不适用

Effect of the Injectable Platelet Rich Fibrin After Tonsillectomy on Wound Healing Hemostasis and Post Operative Pain

Assiut University0 个研究点目标入组 100 人开始时间: 2024年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
IPRF effect on post tonsillectomy pain and bleeding

研究概览

简要总结

To evaluate the effect of injectable Prf on healing, hemostasis and pain post tonsillectomy

详细描述

Tonsillectomy is the most common surgical procedure performed by otolaryngologists with or without adenoidectomy. [1] The most important complication of tonsillectomy is post-tonsillectomy hemorrhage with potential morbidity and death. [2] Also, severe pain and wound healing remain major problems that affect patients profoundly after surgery causing a lot of time to return to a regular diet and normal activity. [3] Pharmacological drugs are used to control post-tonsillectomy pain but with challenges like insufficiency to control pain, the presence of contraindications, and the presence of side effects as the antiplatelet effects of NSAIDs lead to increased rates of postoperative hemorrhage.[4] Growth factors and other mediators released by activated platelets play an important role in tissue regeneration and revascularization. Platelet concentrates, therefore, represent a promising therapeutic tool for tissue regeneration. In recent years, the effects of platelet-rich fibrin (PRF) on tissue healing have been addressed in many surgical branches, especially for dental implant surgery and plastic surgery.[5] Injectable platelet-rich fibrin (IPRF) is a recently developed leukocyte-enriched platelet concentrate, which could better assist tissue regeneration and wound healing phenomena. Although initially in a liquid phase, IPRF forms a dynamic fibrin gel embedding platelets, leukocytes, type 1 collagen (COL1), osteocalcin (OC), growth factors, and providing a slow release of growth factors. [6-10]

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
5 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Any patient indicated for tonsillectomy who will undergo either tonsillectomy alone or adenotonsillectomy

排除标准

  • children who expected to be unreliable in expressing pain due to behavioural pattern or disorder, developmental delayed, age less than 5yrs
  • residence outside the city or patient unable to come for follow-up.
  • children who have high anaesthetic risk or uncontrolled medical illness.
  • bleeding diathesis.
  • acute infection.
  • unilateral tonsillectomy.
  • Hemoglobin level<10mg/dl
  • positive viral markers

结局指标

主要结局

IPRF effect on post tonsillectomy pain and bleeding

时间窗: Assessment of pain and bleeding post tonsillectomy in tested side in comparison with other side Which used as control in first day every 6 hr and then every 3 days to 15 day post operative

Compare tested side and other control side by use of VAS score

IPRF effect on healing

时间窗: Assessment of healing post tonsillectomy in tested side in comparison with other side Which used as control in post tonsillectomy on 3rd day post operative and every 3 days to 15th day post-operative

Assessment of healing on both sides of tonsillar beds post tonsillectomy one tested side (injectable platelet rich fibrin injected in) other control (IPRF not used) by assessment of pinkish membrane percent of the coverage on the tonsillar fossa comparing the tested site and control site at the 3rd, 6th, and every 3 days to 15th day post-operative and score will be calculated as if pinkish membrane percent of coverage on the tonsillar fossa less than 10% score 0, If pinkish membrane percent of coverage on 10\_25%score1,when pinkish membrane percent of coverage on the tonsillar fossa 25\_50%score2,If pinkish area more 50%score3

次要结局

未报告次要终点

研究者

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

Shaimaa Mohamed Awad Allah

Resident

Assiut University

相似试验