Effect of Thymoquinone and Olive Oil on Wound Healing After Endoscopic Sinus Surgery in Patients With Nasal Polyposis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Determining the effectiveness of Thymoquinone (0.5%) and olive oil on Wound healing after Endoscopic sinus surgery regarding crust formation by Endoscopic examination.
研究概览
简要总结
This study aims to determine the effect of Thymoquinone (0.5%) and olive oil ointment on Wound healing after Endoscopic sinus surgery.
详细描述
Endoscopic sinus surgery (ESS) has become a widely accepted procedure for medically refractory chronic rhino sinusitis and nasal polyps. Over 250,000 endoscopic sinus surgeries are performed yearly in the United States alone, however, postoperative complications and disease recurrence requiring revision surgery are reported in 14% to 24% of patients in long-term follow-up.
There is an increasing interest in interventions and therapies targeted at optimizing outcomes and preventing revision surgery which often depends on good wound healing and less adhesion formation.
The choice of appropriate post-surgical topical treatments is important for healing time and for preventing mucosal complications such as adhesions, crusting formation, and atrophy with secondary bacterial and fungal infections in this light this study aims to determine the effect of thymoquinone and olive oil ointment on wound healing after ESS.
Thymoquinone (TQ) is the most abundant constituent of the volatile oil of Nigella sativa seeds and most properties of Nigella sativa are mainly attributed to TQ. Several pharmacological actions and therapeutic potentials of TQ have been investigated including being antioxidant, anti-inflammatory, antihistaminic, antimicrobial, anti-allergic, anti-fibrotic, and anti-cancer.
Olive oil plays an important role in wound healing process due to its content of phenolic compounds accelerating wound healing through their anti-inflammatory, antioxidant, and antimicrobial properties and their stimulation of angiogenic activities required for granulation tissue formation and wound re-epithelialization.
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
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients who will be clinically diagnosed and radiologically confirmed cases with bilateral nasal polyposis indicated for Endoscopic sinus surgery.
排除标准
- •Unfit patient for surgery
- •Pregnant and lactating women.
- •Patients unwilling to participate.
- •Patients who have unilateral disease.
- •Patients with a history of the following underlying medical conditions, which are associated with an increased rate of revision surgery, will be excluded from the study:
- •Aspirin intolerance
- •Mucociliary disorder
- •Immunocompromised status.
- •Patients with known allergic reactions to Thymoquinone or olive oil.
- •Injury of the orbit with any tear in the periorbital area.
结局指标
主要结局
Determining the effectiveness of Thymoquinone (0.5%) and olive oil on Wound healing after Endoscopic sinus surgery regarding crust formation by Endoscopic examination.
时间窗: Patients will attend routine follow-up at 1, 2,3,4,8 and 12 weeks after surgery
Endoscopic data regarding the health of the Sino nasal mucosa will be collected. An independent investigator blinded to the side of TQ, and olive oil ointment placement will assess and compare the wound healing in both sides. crust formation will be scored as following: 0: No crust formation observed. 1. Thin and easily removable crusts. 2. Moderate crust formation, requiring gentle removal. 3. Thick and adherent crusts, requiring careful and meticulous removal. 0 is the lowest score meaning no crusts are formed while 3 is the highest score meaning severe crusts are formed.
Determining the effectiveness of Thymoquinone (0.5%) and olive oil on Wound healing after Endoscopic sinus surgery regarding adhesions by Endoscopic examination.
时间窗: Patients will attend routine follow-up at 1, 2,3,4,8 and 12 weeks after surgery
Endoscopic data regarding the health of the Sino nasal mucosa will be collected. An independent investigator blinded to the side of TQ, and olive oil ointment placement will assess and compare the wound healing in both sides. adhesions will be scored as following: 0: No adhesions observed. 1. Mild adhesions, limited to small areas. 2. Moderate adhesions, affecting larger areas but without complete obstruction. 3. Severe adhesions, causing significant obstruction and impaired sinus drainage. 0 is the lowest score meaning no adhesions are formed while 3 is the highest score meaning severe adhesions are formed.
Determining the effectiveness of Thymoquinone (0.5%) and olive oil on Wound healing after Endoscopic sinus surgery regarding granulation formation by Endoscopic examination
时间窗: Patients will attend routine follow-up at 1, 2,3,4,8 and 12 weeks after surgery
Endoscopic data regarding the health of the Sino nasal mucosa will be collected. An independent investigator blinded to the side of TQ, and olive oil ointment placement will assess and compare the wound healing in both sides. Granulations will be scored as following: 0: No granulations observed. 1. Mild granulation tissue, with minimal vascularity and minimal elevation. 2. Moderate granulation tissue, with moderate vascularity and noticeable elevation. 3. Severe granulation tissue, with marked vascularity and significant elevation. 0 is the lowest score meaning no granulation tissue is formed while 3 is the highest score meaning severe granulation tissue are formed.
Determining the effectiveness of Thymoquinone (0.5%) and olive oil on Wound healing after Endoscopic sinus surgery regarding infection by Endoscopic examination.
时间窗: Patients will attend routine follow-up at 1, 2,3,4,8 and 12 weeks after surgery
Endoscopic data regarding the health of the Sino nasal mucosa will be collected. An independent investigator blinded to the side of TQ, and olive oil ointment placement will assess and compare the wound healing in both sides. Infection will be scored as following: 0: No signs or symptoms of infection observed. 1. Mild infection, mucopurulent discharge limited to small area of the ethmoidal cavity. 2. Moderate infection, mucopurulent discharge filling one sinus. 3. Severe infection, mucopurulent discharge filling more than one sinus. 0 is the lowest score meaning there is no infection while 3 is the highest score meaning there is severe infection.
次要结局
- Evaluation of symptoms of CRS and NP after Endoscopic Sinus Surgery using SNOT22 questionnaire.(Patients will attend routine follow-up at 1, 2,3,4,8 and 12 weeks after surgery)
研究者
Tarek Ashraf Abdelhasib
Principal Investigator
Assiut University