Effect of Topical Active Oxygen Therapy on Surgical Site Wound Healing and Microbial Colonization : Randomized Controlled Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Microbiological assessment
研究概览
简要总结
To assess the antibacterial efficiency of oxygenated gel therapy on wound healing and microbiological colonization around surgical sutures
详细描述
All the patients who will agree to participate in the study and who will sign the informed consent forms. Computer-generated randomization will be used to randomly divide the surgical sites into two groups. Control group: will receive no treatment. Study group: will receive active oxygen gel around suture. Patients scheduled for any oral surgical flap procedure that require suturing will be included in this study. After flap approximation, the surgical site will be sutured using 5-0 braided sutures. In the study group the gel will be applied over the suture and the patients will be instructed to apply the gel to the wound area and to the suture thread using a cotton swab, three times a day after brushing their teeth. Also, patients will be given instructions regarding their post-surgical care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients in a healthy systemic condition who required comprehensive dental treatment
- •Both genders with age group > 18 years old
- •Patients should approve to deliver a signature to a written consent after study nature explanation.
排除标准
- •Patients with severe smoking habits >10 cig \ day
- •Pregnant females, decisional impaired individuals and handicapped patients
- •Patients having poor oral hygiene or not wanting to carry out oral hygiene measures
- •Patients on any medication affecting the soft tissue health (e.g., amlodipine, Cyclosporine A, hydantoin)
研究组 & 干预措施
control
patient who will undergo intraoral surgical procedures , will have his wound sutured without any addtives
test
patient who will undergo intraoral surgical procedures , will have his wound sutured with the addition of blue m gel twice daily
结局指标
主要结局
Microbiological assessment
时间窗: 2 weeks
The collected samples of suture thread will be immersed in phosphate-buffered saline solution (PBS) immediately after their removal and This sample will be subsequently sent to the microbiology laboratory of the Faculty of Pharmacy of the British university in Egypt. The samples will be shaken vigorously for two minutes to separate the bacteria from the suture thread, and to obtain a homogeneous suspension. serial dilutions in saline will be subsequently prepared. 50 microliters of each dilution will be plated in Petri dishes containing different culture media.The blood agar, mannitol agar, MacConkey agar, and Sabouraud agar plates will be aerobically incubated at 37 °C for 24-48 hours. After incubation, the colony forming units (CFUs) will be counted and the total number of CFUs per milliliter of initial solution will be calculated
次要结局
- Post operative wound healing.(2 weeks)
研究者
ahmed hamdy mahmoud
assistant lecturer
British University In Egypt