Circumcision, MaleNCT05764889
Study on the Protective Effect of a Flexible Sleeve Penis Protection Device on Penis After Circumcision
A study testing wrapped with the Flexible Sleeve Penis Protection Device and wrapped with traditional gauze in people with Circumcision, Male, run by Liu Zhuo at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 60 years, men only
- Conditions the study is for
- Circumcision, Male
- What is being tested?
- wrapped with the Flexible Sleeve Penis Protection Device and wrapped with traditional gauze
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2023to 30 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 60 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
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.
Read the 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.
- Conditions
- Circumcision, Male
- Being tested
- wrapped with the Flexible Sleeve Penis Protection Device, wrapped with traditional gauze
- Keywords
- Circumcision, Postoperative complications, Protection devices
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wrapped with the Flexible Sleeve Penis Protection DeviceOther
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.
wrapped with traditional gauzeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Patients in the experimental group were wrapped with the Flexible Sleeve Penis Protection Device post-operatively. Receives: Other: wrapped with the Flexible Sleeve Penis Protection Device |
| Control group | Other | Patients in the control group were wrapped with traditional gauze after operation. Receives: Other: wrapped with traditional gauze |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative complication
Assessing the incidence of post-operative complications
Measured: 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
Measured: through study completion, an average of 12weeks
Healing time
Time for sutures to come off completely and time for wound healing
Measured: through study completion, an average of 12weeks
Secondary outcomes (2)
Wound pain assessment
Using the Visual analogue scale ，which includes 0-10 points. A higher score means more pain
Measured: through study completion, an average of 12weeks
Comfort and convenience assessment
Comfort and convenience assessed by questionnaire
Measured: through study completion, an average of 12weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start15 Mar 2023
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Circumcision, MaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients in the experimental group were wrapped with this device postoperatively Patients in the control group were wrapped with traditional gauze postoperatively.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liu Zhuo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Liu Zhuo, Peking University Third Hospital
- Investigators
- Zhuo Liu, MD, Study director, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05764889
- Sponsor's protocol ID
- M2022628
- Status last verified
- Mar 2023
- First submitted
- 9 Feb 2023
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mu J, Fan L, Liu D, Zhu D. A Comparative Study on the Efficacy of Four Types of Circumcision for Elderly Males with Redundant Prepuce. Urol J. 2020 May 16;17(3):301-305. doi: 10.22037/uj.v0i0.4973.
PubMed 31364098Abara EO. Prepuce health and childhood circumcision: Choices in Canada. Can Urol Assoc J. 2017 Jan-Feb;11(1-2Suppl1):S55-S62. doi: 10.5489/cuaj.4447.
PubMed 28265321Soltany S, Ardestanizadeh A. The study of the factors affecting the time of ring fall off in circumcision using Plastibell. J Family Med Prim Care. 2020 Jun 30;9(6):2736-2740. doi: 10.4103/jfmpc.jfmpc_1261_19. eCollection 2020 Jun.
PubMed 32984117van den Dungen IAL, Rynja SP, Bosch JLHR, de Jong TPVM, de Kort LMO. Comparison of preputioplasty and circumcision in distal hypospadias correction: long-term follow-up. J Pediatr Urol. 2019 Feb;15(1):47.e1-47.e9. doi: 10.1016/j.jpurol.2018.08.001. Epub 2018 Aug 20.
PubMed 30270101
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Protective Effect of a Flexible Sleeve Penis Protection Device on Penis After Circumcision
- ClinicalTrials.gov ID
- NCT05764889
- Acronym / sponsor ID
- M2022628
- Conditions
- Circumcision, Male
- Keywords
- Circumcision, Postoperative complications, Protection devices
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Liu ZhuoUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jul 2023 (estimated)
- First posted
- 13 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients in the experimental group were wrapped with this device postoperatively Patients in the control group were wrapped with traditional gauze postoperatively.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: wrapped with the Flexible Sleeve Penis Protection DevicePatients in the experimental group were wrapped with the Flexible Sleeve Penis Protection Device post-operatively. |
| Control group | Other | Other: wrapped with traditional gauzePatients in the control group were wrapped with traditional gauze after operation. |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| wrapped with the Flexible Sleeve Penis Protection DevicePatients 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. | Other | Experimental group |
| wrapped with traditional gauzePatients 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. | Other | Control group |
Primary outcome
Post-operative complication
Time frame: through study completion, an average of 12weeks
Assessing the incidence of post-operative complications
Foreskin edema score
Time frame: 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
Healing time
Time frame: through study completion, an average of 12weeks
Time for sutures to come off completely and time for wound healing
2 secondary outcomes
Wound pain assessment
Time frame: through study completion, an average of 12weeks
Comfort and convenience assessment
Time frame: through study completion, an average of 12weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Background: PubMed 31364098Mu J, Fan L, Liu D, Zhu D. A Comparative Study on the Efficacy of Four Types of Circumcision for Elderly Males with Redundant Prepuce. Urol J. 2020 May 16;17(3):301-305. doi: 10.22037/uj.v0i0.4973.
- Background: PubMed 28265321Abara EO. Prepuce health and childhood circumcision: Choices in Canada. Can Urol Assoc J. 2017 Jan-Feb;11(1-2Suppl1):S55-S62. doi: 10.5489/cuaj.4447.
- Background: PubMed 32984117Soltany S, Ardestanizadeh A. The study of the factors affecting the time of ring fall off in circumcision using Plastibell. J Family Med Prim Care. 2020 Jun 30;9(6):2736-2740. doi: 10.4103/jfmpc.jfmpc_1261_19. eCollection 2020 Jun.
- Background: PubMed 30270101van den Dungen IAL, Rynja SP, Bosch JLHR, de Jong TPVM, de Kort LMO. Comparison of preputioplasty and circumcision in distal hypospadias correction: long-term follow-up. J Pediatr Urol. 2019 Feb;15(1):47.e1-47.e9. doi: 10.1016/j.jpurol.2018.08.001. Epub 2018 Aug 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhuo Liu, MD study director
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wrapped with the Flexible Sleeve Penis Protection Device and wrapped with traditional gauze in people with Circumcision, Male, run by Liu Zhuo at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative complication (time frame: through study completion, an average of 12weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05764889, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2023.