Use of Antibiotic Irrigation to Decrease Wound Infections in Pediatric Perforated Appendicitis
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- wound complications
研究概览
简要总结
The proposed study will investigate whether antibiotic irrigation using a gentamicin/clindamycin solution during laparoscopic appendectomy is superior in preventing postoperative wound infections and IAA in perforated appendicitis compared to suction without irrigation. This will be the first prospective study to compare these two options in pediatric PA.
详细描述
This study is for pediatric patients who are having an appendectomy and have a perforated appendix. The purpose of this study is to see whether antibiotic irrigation using gentamicin, clindamycin and suction during the surgery works better when compared to suction alone when cleaning the stomach cavity.
Arm A patients will have their abdomen irrigated with the antibiotics, gentamycin and clindamycin, and then the wound will be suctioned out. Arm B patients will not have the antibiotic irrigation but will have their wound suctioned.
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)
盲法说明
there is no masking after randomization
入排标准
- 年龄范围
- 0 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age 18 years or younger
- •Scheduled to undergo laparoscopic appendectomy
- •Preoperative or intra-operative diagnosis of perforated appendicitis (PA).
- •Willingness to undergo treatments, provide written informed consent, and participate in follow-up.
排除标准
- •Male or female older than 18 years of age
- •Declined to undergo laparoscopic appendectomy
- •Not willing to provide written informed consent or undergo randomization of treatment
研究组 & 干预措施
Antibiotic irrigation with suction
Group A: You will receive antibiotic irrigation with suction if a PA is found during surgery
干预措施: antibiotic rinse with suction (Drug)
suction only
Group B: You will receive suction alone if a PA is found during surgery
干预措施: suction only (Procedure)
结局指标
主要结局
wound complications
时间窗: 30 days
The overall objective is to change the postoperative wound complications and IAA after laparoscopic appendectomy for perforated appendicitis in pediatric patients. The outcome will be measured by tracking any wound complications that these patients have and comparing the incidence between treatment arms
次要结局
未报告次要终点