Study on the Protective Effect of a Flexible Sleeve Penis Protection Device on Penis After Circumcision

Not Applicable

• Conditions: Circumcision, Male
• Interventions: Other: wrapped with the Flexible Sleeve Penis Protection Device; Other: wrapped with traditional gauze

• Registration Number: NCT05764889
• Lead Sponsor: Liu Zhuo

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2023-02-09
• Study First Submitted QC: 2023-02-28
• Status Verified: 2023-03
• Study First Posted: 2023-03-13
• Study Start: 2023-03-15
• Last Update Submitted: 2023-03-29
• Last Update Posted: 2023-03-31
• Primary Completion: 2023-06-30
• Study Completion: 2023-07-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

1. Diagnosed redundant prepuce and circumcised at Peking University Third Hospital.
2. Male patients aged between 12 and 60 years (inclusive).
3. The person or guardian fully understands and signs the informed consent form.

Exclusion Criteria

1. Acute urinary and genital infections, such as acute urethritis, acute prostatitis, acute epididymitis, etc., or trauma.
2. Abnormal blood clotting function.
3. Those who are allergic to the materials used in the manufacture of the product.
4. Patients who are mentally incapable or unable to understand the requirements for participation in the study and have difficulty in cooperating.
5. Subjects who, in the opinion of the investigator, are unable to comply with follow-up, compromising the scientific validity and integrity of the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	wrapped with the Flexible Sleeve Penis Protection Device	Patients in the experimental group were wrapped with the Flexible Sleeve Penis Protection Device post-operatively.
Control group	wrapped with traditional gauze	Patients in the control group were wrapped with traditional gauze after operation.

Primary Outcome Measures

Name	Time	Method
Healing time	through study completion, an average of 12weeks	Time for sutures to come off completely and time for wound healing
Post-operative complication	through study completion, an average of 12weeks	Assessing the incidence of post-operative complications
Foreskin edema score	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

Secondary Outcome Measures

Name	Time	Method
Wound pain assessment	through study completion, an average of 12weeks	Using the Visual analogue scale ，which includes 0-10 points. A higher score means more pain
Comfort and convenience assessment	through study completion, an average of 12weeks	Comfort and convenience assessed by questionnaire

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China