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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-15

Study Completion Date

2023-07-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Circumcision, Male

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients in the experimental group were wrapped with this device postoperatively Patients in the control group were wrapped with traditional gauze postoperatively.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Experimental group

Patients in the experimental group were wrapped with the Flexible Sleeve Penis Protection Device post-operatively.

Group Type EXPERIMENTAL

wrapped with the Flexible Sleeve Penis Protection Device

Intervention Type OTHER

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.

Control group

Patients in the control group were wrapped with traditional gauze after operation.

Group Type OTHER

wrapped with traditional gauze

Intervention Type OTHER

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.

Interventions

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wrapped with the Flexible Sleeve Penis Protection Device

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.

Intervention Type OTHER

wrapped with traditional gauze

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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No