Granulated Sucrose as a Standard in Cesarean Section Surgical Wound Healing to Reduce Hospital Time. Single-blind Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Changes of in-hospital days
研究概览
简要总结
It is a randomized, single-blind clinical trial, whose population to be studied will be randomized patients with a diagnosis of dehiscence and infection of a cesarean surgical wound who meet the inclusion and exclusion criteria.
H0: Sucrose does not reduce hospital days in patients with surgical wound dehiscence.
HA: Sucrose reduces hospital days in patients with surgical wound dehiscence.
详细描述
Cesarean section is one of the most performed surgical interventions at the Maternal and Child Hospital. Infection and dehiscence of the surgical site are some of the most common complications in post-cesarean section patients. The Honduran population, like those around the world, is susceptible to surgical site infections due to several risk factors and depends on each patient. Regarding the patients treated at the Maternal and Child Hospital, a surgical site risk of approximately 2-3% is estimated. Therefore, the investigators consider it beneficial to look for alternatives to treating surgical infections that help to reduce hospital time. Granulated sucrose has previously been used as a method for treating surgical wounds, however, no trial has been conducted to determine the benefits of its use.
Therefore, the investigators consider that it will be beneficial for the Gynecology and Obstetrics service of the Maternal and Child Hospital, especially the Septic ward, to carry out a study that helps to determine if the use of granulated sucrose reduces the hospitalization time of patients with infection and dehiscence of the surgical site due to cesarean section, as well as replacing the use of other methods that must be paid for by the patients.
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)
盲法说明
Both the patients and 3 researchers will know the intervention, however, the groups will be listed and during the analysis phase, the analyst researcher will not know which group each patient corresponds to.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Delivery of a signed and dated informed consent form.
- •Declared willingness to comply with all study procedures and availability for the duration of the study.
- •Women from 18 to 45 years old
- •Enjoy good general health, as demonstrated by your medical history, and have been diagnosed with post-cesarean surgical wound dehiscence and fascia integra.
- •Ability to take oral medication and be willing to comply with the sucrose regimen.
- •Agreement to comply with Lifestyle Considerations
排除标准
- •Known allergic reactions to sucrose components.
- •Treatment with another investigational drug or other intervention within the previous 7 days.
- •Current smoker or tobacco consumption within the previous 3 months.
- •Treatment with antibiotics at least 2 weeks before hospitalization
- •Reinterventions before hospitalization
结局指标
主要结局
Changes of in-hospital days
时间窗: from the first intervention to delayed primary closure (by third intention), on average less than 14 days
from the intervention days
次要结局
- Change of Satisfaction scale for scar assessment(3 months)
研究者
Ricardo A Gutierrez Ramirez, MD, MSc, FACOG
Professor, research coordinator of the postgraduate course in gynecology and obstetrics
Universidad Nacional Autonoma de Honduras