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临床试验/CTRI/2025/08/093303
CTRI/2025/08/093303尚未招募不适用

Comparison of the effectiveness of stainless-steel scalpel and electrocautery in oral mucoperiosteal incision wound outcome, in oral major surgical procedure – A clinical trial

Saraswathi Lakshmi Yatam1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2025年9月9日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
26
试验地点
1
主要终点
To compare the efficacy of electrocautery and stainless-steel scalpel incisions in oral surgical procedures in terms of time taken for incision, healing efficacy, blood loss, post operative pain assessment, scar formation.

研究概览

简要总结

Precise incisions are essential in oral and maxillofacial surgery where controlled access and optimal healing are critical for successful outcomes. Scalpel blades are traditionally used for oral incision which offers refined cutting precision but poses challenges such as bleeding and the need for additional hemostatic measure. Alternative source to achieve hemostasis was electrocautery.  This results in cauterizing the blood vessels in the surgical site and provides a bloodless field. Although numerous studies have investigated parameters such as blood loss, incision time and healing for both technique the impact on scar formation remains underexplored. This study aims to compare the effectiveness of electrocautery and scalpel based on fate of incision by assessing the scar formation, bleeding, wound healing, pain and time taken for incision. The study design is randomized clinical trial with sample size of 26. Inclusion criteria are patients who require oral vestibular incision for management and correction of any facial deficits, orthognathic surgical procedures which require intra oral vestibular incision, Oral and Maxillofacial pathologies involving only hard tissue which require intra-oral mucosal incision, patient more than 18 years old, healthy patients under ASA I and II. Exclusion criteria include medically compromised patients such as patients with history of bleeding disorder, collagen disorder, diabetes, hypertension, ASA III, IV, V and VI, presence of bone fractures in the region, presence of pathology along the line of incision, presence of intraoral laceration or wound in the site of incision, presence of ecchymosis in the site of incision.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Patients who require oral vestibular incision for management and correction of any facial deficits.
  • Orthognathic surgical procedures which require intra-oral vestibular incision.
  • Oral and maxillofacial pathologies involving only hard tissue which require intra-oral mucosal incisions.
  • Patient more than 18 years old.
  • Healthy patients, ASA I & II.

排除标准

  • Medically compromised patients such as patients with history of bleeding disorder, collagen disorder, diabetes, hypertension, ASA III, IV, V, VI.
  • Presence of bone fractures in the region.
  • Presence of pathology along the line of incision.
  • Presence of intra oral laceration/wound in the site of incision.
  • Presence of ecchymosis in the site of incision.

结局指标

主要结局

To compare the efficacy of electrocautery and stainless-steel scalpel incisions in oral surgical procedures in terms of time taken for incision, healing efficacy, blood loss, post operative pain assessment, scar formation.

时间窗: Time taken for incision and bleeding measured at baseline during surgery. | Post-operative pain, healing efficacy measured within 2 weeks after surgery. | Mucosal scarring index measured within 12 weeks

次要结局

未报告次要终点

研究者

发起方
Saraswathi Lakshmi Yatam
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Saraswathi Lakshmi Yatam

Amrita Vishwa Vidyapeetham Amrita School of Dentistry

研究点 (1)

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