Study on the Protective Effect of a Flexible Sleeve Penis Protection Device on Penis After Circumcision
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Healing time
研究概览
简要总结
Circumcision is a common clinical procedure for both circumcision and phimosis, which are common disorders of the male reproductive system. For post-circumcision patients, a flexible sleeve penile protection device was invented as a modification of the traditional gauze bandage. This study investigated the protective effect of the device by recruiting post-circumcision patients to use the device and collecting indicators related to post-operative recovery and patients' experience of using the device.
详细描述
Circumcision is a common clinical procedure for both circumcision and phimosis, which are common disorders of the male reproductive system. Post-circumcision patients remain at risk of gauze detachment, wound pain and post-operative bleeding, leading to serious post-operative adverse effects, including complications such as dehiscence and infection. The investigators have invented a flexible sleeve penile protection device, which consists of two components, a flexible sleeve and a hood, the main function of the flexible sleeve is to stop bleeding with compression and immobilisation, and the main function of the hood is to provide protection to the head of the penis and prevent the wound from rubbing against clothing leading to pain.
The aim of this study was to investigate the protective effect of a flexible sleeve penile protection device on post-circumcision patients in terms of gauze loosening and dislodging, post-operative pain and post-operative bleeding. This study was a prospective randomized controlled trial of patients who underwent circumcision at Peking University Third Hospital from February 2023 to May 2023. Patients in the experimental group were wrapped with this device postoperatively, while patients in the control group were wrapped with traditional gauze postoperatively. Patients were followed up regularly after surgery, and indicators such as complications, pain and recovery time were collected to investigate the protective effect of this device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 60 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosed redundant prepuce and circumcised at Peking University Third Hospital.
- •Male patients aged between 12 and 60 years (inclusive).
- •The person or guardian fully understands and signs the informed consent form.
排除标准
- •Acute urinary and genital infections, such as acute urethritis, acute prostatitis, acute epididymitis, etc., or trauma.
- •Abnormal blood clotting function.
- •Those who are allergic to the materials used in the manufacture of the product.
- •Patients who are mentally incapable or unable to understand the requirements for participation in the study and have difficulty in cooperating.
- •Subjects who, in the opinion of the investigator, are unable to comply with follow-up, compromising the scientific validity and integrity of the study.
结局指标
主要结局
Healing time
时间窗: through study completion, an average of 12weeks
Time for sutures to come off completely and time for wound healing
Post-operative complication
时间窗: through study completion, an average of 12weeks
Assessing the incidence of post-operative complications
Foreskin edema score
时间窗: through study completion, an average of 12weeks
Assessment of foreskin oedema which includes 0-6 points. A higher score means a more severe case of penile foreskin oedema
次要结局
- Wound pain assessment(through study completion, an average of 12weeks)
- Comfort and convenience assessment(through study completion, an average of 12weeks)
研究者
Liu Zhuo
Attending Doctor
Peking University Third Hospital