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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
60
Patients in the experimental group were wrapped with the Flexible Sleeve Penis Protection Device post-operatively. Patients in the control group were wrapped with traditional gauze post-operatively.
Patients in the experimental group were wrapped with the Flexible Sleeve Penis Protection Device post-operatively. Patients in the control group were wrapped with traditional gauze post-operatively.
Peking University Third Hospital
Beijing, Beijing Municipality, China
Post-operative complication
Assessing the incidence of post-operative complications
Time frame: through study completion, an average of 12weeks
Foreskin edema score
Assessment of foreskin oedema which includes 0-6 points. A higher score means a more severe case of penile foreskin oedema
Time frame: through study completion, an average of 12weeks
Healing time
Time for sutures to come off completely and time for wound healing
Time frame: through study completion, an average of 12weeks
Wound pain assessment
Using the Visual analogue scale ，which includes 0-10 points. A higher score means more pain
Time frame: through study completion, an average of 12weeks
Comfort and convenience assessment
Comfort and convenience assessed by questionnaire
Time frame: through study completion, an average of 12weeks
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