To Investigate the Effect of Continuous Versus Interrupted Subcutaneous Fat Closure in Reducing Surgical Site Infection Among Over-weight or Obese Women Who Are Undergoing Elective Caesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 266
- 主要终点
- Surgical Site infection
研究概览
简要总结
This research aims to clarify the best way to perform subcutaneous tissue closure in overweight and obese patients undergoing caesarean section to reduce the occurrence of surgical site infections. This Study seeks to get some local perspective on the need for and type of subcutaneous fat closure in obese women undergoing cesarean section, thereby reducing Surgical Site Infection. This is a pilot; double- blinded randomized control trial, with balanced randomization (1:1) and parallel grouped study. The sample size calculated by Raosoft Sample Size Calculator Software determined that based on a margin of error of 5%, there would need to be 266 participants to give 90% confidence level to detect a significant difference between both arms of the study. Patients who are immune-compromised, those with anemia, requiring transfusion will be excluded from the study, also any mother who wishes not to participate. Patients will be reviewed 7 days post operatively. Wound complications will be identified by a questionnaire by telephone at 4 weeks and 3 months post operatively. Data will be collected from Specific closed answer questions. Data extraction sheet will be used to collect data for the patient. This information will be collected either from the docket, direct review or examination of the study participants. The research will be done at Victoria Jubilee Hospital. The Research will last six months.
详细描述
Background and Rationale for the study
Caesarean Section is the most common abdominal operation performed worldwide. At the Victoria Jubilee Hospital, the C-Section rate is 23.2% for 2021. Wound complications are encountered in about 3-15% (5) of women undergoing C- section and this includes: hematomas, seromas and wound infections. Given the trend of rising C-Section rate, the associated complications also increase. Obesity has a direct effect on wound complication rate. Obesity is a complex medical disorder characterized by an excess of total body fat. A body max index (BMI) of 25 kg/m2 to < 30 kg/m2 constitutes overweight and obesity with a BMI of 30 kg/m2.Data from the 2016/17 Jamaica Health and Lifestyle Survey showed that one in two Jamaicans or 54% were overweight or obese. The data further revealed that women are more affected by overweight/obesity, with two-thirds of Jamaican women 15 years or older being overweight or obese (4).
Abdominal wall closure is performed traditionally by using a 3 layer technique in which the parietal peritoneum with the posterior rectus sheath, anterior rectus sheath and skin are individually and sequentially closed. Camper's fascia provides a potential space for hematoma and seroma formation. The vascular supply to subcutaneous fat is relatively poor making the tissue susceptible to infection. A good surgical technique is the one that eliminates the dead space in subcutaneous tissue and approximates edges without tension. The suturing of subcutaneous tissue aims to reduce the risk of formation of fluid reservoirs theoretically reducing the rate of postoperative hematoma and seroma development.
A Meta-Analysis of 6 studies showed that suturing reduces the risk of wound complications by 34% in subcutaneous tissue greater than 2cm. Only a small number of research studies evaluated the impact of various subcutaneous tissue closure methods at C-Section (1).
A Retrospetive study between 2008 to 2018 compared surgical site infections (SSI) between continuous versus interrupted subcutaneous tissue closure during cesarean delivery in women with fat thickness > 2cm. The study concluded that continuous subcutaneous tissue closure yielded a lower rate of surgical site infection complications compared to interrupted subcutaneous tissue closure (2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Overweight/Obese Women > 25kg/m2, measured in the first trimester
- •Single Fetus
- •Gestational Age (37-41) week calculated by sure dates and confirmed by first trimester ultrasound
- •Elective Lower Segment Cesarean Section
排除标准
- •Patients who are immune-compromised e.g. Known Diabetes Mellitus or HIV positive mothers
- •Patients who are on long term Steroid use: e.g. SLE, Rheumatoid Arthritis
- •Multifetal Pregnancy
- •Those with anemia, requiring transfusion
- •Obstetric Complications: e.g. Placenta Previa
- •Any mother who wishes not to participate in the study
结局指标
主要结局
Surgical Site infection
时间窗: 12 weeks
Patients will be reviewed on Day 3 post-operatively on the surgical ward. The patients will also be reviewed on Day 7. During Week 4 and Week 12 post-operatively they will be reviewed via a telephone conversation and asked specific closed answer questions regarding the incision site to assess any thought of SSI when being reviewed.
次要结局
未报告次要终点