Investigating the Impact of Topical Insulin on Postoperative Wound Healing in Diabetic and Non-Diabetic Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Calculation of Unit Healing Time index
研究概览
简要总结
This study aimed to investigate the potential effect of applying topical insulin therapy on the management and healing of postoperative wounds in patients known with type 2 diabetes mellitus (T2DM) and in a parallel group without diabetes. Investigators also studied the effect of topical insulin therapy on the expression of e-cadherin and Ki67, as markers for cellular proliferation and wound repair. The levels of IL-6 and the H2O2-induced DNA damage product, 8-hydroxy-2'-deoxyguanosine (8-OHdG), were assessed as markers for inflammation and oxidative stress. Finally, histomorphological assessment of skin biopsies was also carried out.
详细描述
The study participants will be recruited from general surgery department ,all patients with elective surgical procedure who will be admitted at the department for at least one week as it is the minimal duration of postoperative wound healing and the study will be conducted according to the regulations of ethical committee of clinical studies in the Faculty of Medicine, Cairo University
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 (Participant)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both males and females
- •40-60 years old
- •diagnosed with type 2 DM (for the diabetic trial)
- •For the diabetic trial: glycosylated hemoglobin (HBA1c) ≤7.5 %
- •haemoglobin (Hb) ≥ 12 g/dl
- •Patients who had a full thickness post-operative wound of ≥10 cm
排除标准
- •Those with known history of immunodeficiency, keloid formation, or hyperkeratotic skin lesion.
- •Patients who had hypersensitivity to insulin,
- •Patients with severe infection,
- •Patients with any severe organ dysfunction
- •Patients who were admitted to ICU
研究组 & 干预措施
Povidone iodine 10%
干预措施: Povidone-Iodine (Drug)
Topical insulin
干预措施: Insulin (Drug)
结局指标
主要结局
Calculation of Unit Healing Time index
时间窗: Before and after 7 days of therapy
The total healing days and the surface area of the wound will be combined to report unit healing time in units
次要结局
未报告次要终点
研究者
Omnia Azmy Nabeh
Principal investigator
Cairo University