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A prospective, single-center, randomized, parallel controlled, optimal clinical trial to evaluate the safety and efficacy of Photocuring Wound Sealant in the prevention and treatment of prepuce adhesion in children

A prospective, single-center, randomized, parallel controlled, optimal clinical trial to evaluate the safety and efficacy of Photocuring Wound Sealant in the prevention and treatment of prepuce adhesion in children

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500103345
Enrollment
Unknown
Registered
2025-05-28
Start date
2025-05-17
Completion date
Unknown
Last updated
2025-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adherent prepuce

Interventions

Experimental group:Photocuring Wound Sealant

Sponsors

The Second Affiliated Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
5 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1.The subject was confirmed to have prepuce adhesions and the adhesions needed to be removed; 2.The adhesive grade of the foreskin is rated as Class II, III and IV; 3.Subjects were males aged 5-12 years (including boundary values); 4.Subjects who voluntarily participated in this study and signed the informed consent form;

Exclusion criteria

Exclusion criteria: 1.Susceptibility to allergies or scarring; 2.malnutrition; 3.Penile malformations such as hypospadias and penile flexion; 4.An acute attack of hydatitis; 5.Severe urinary tract infection; 6.The condition is serious and life-threatening; 7.Have serious heart, liver, kidney, lung dysfunction and other diseases; 8.There are other underlying diseases; 9.Subjects need topical growth factor products and topical glucocorticoid products; 10.Subjects are in the midst of severe, uncontrolled acute or chronic local or systemic infection; 11.Participants had participated in other clinical trials within the last 3 months; 12.Subject has allergic or hypersensitive reaction to erythromycin; 13.Subjects are allergic to product ingredients; 14.Any medical history that the investigator determines may interfere with the test results or increase the patient's risk; 15.Subjects with grade I foreskin adhesion;

Design outcomes

Primary

MeasureTime frame
The cure rate of prepuce adhesions;

Secondary

MeasureTime frame
The cure rate of prepuce adhesions;The incidence of difficulty in urination;The incidence of redness and swelling of the foreskin;

Countries

China

Contacts

Public ContactZhu Libin

The Second Affiliated Hospital of Wenzhou Medical University

wz.zhulibin@aliyun.com+86 13957754004

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026