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Evaluation of efficacy and safety of Collagen Sponge in promoting wound repair in after loop electrosurgical excision procedure: a prospective, randomized, controlled, single-blinded, multicenter, exploratory study

Evaluation of efficacy and safety of Collagen Sponge in promoting wound repair in after loop electrosurgical excision procedure: a prospective, randomized, controlled, single-blinded, multicenter, exploratory study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000041341
Enrollment
Unknown
Registered
2020-12-23
Start date
2021-01-01
Completion date
Unknown
Last updated
2021-03-08

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

Conditions

Cervical high grade squamous intraepithelial lesions/Cervical intraepithelial neoplasia

Interventions

Trial Group:Collagen Sponge (Trauer)
Positive control group:Collagen Sponge (Yierkang)
Control group:Nil

Sponsors

Guangzhou Women and Children's Medical Center
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years and premenopausal women; 2. Patients with high-grade cervical squamous epithelial lesions (HSIL) or uterine intraepithelial neoplasia CIN2/CIN3 diagnosed pathologically and undergoing LEEP surgery.

Exclusion criteria

Exclusion criteria: 1. Subjects with a history of severe allergy; 2. Subjects with acute reproductive tract infection; 3. Patients with serious systemic diseases, including anemia, systemic infection, malignant tumor, autoimmune diseases, coagulation disorders, mental diseases, diabetes, etc.; 4. Pregnant and lactating women; 5. Subjects who participated in other clinical trials 30 days before enrollment; 6. There are other situations that the researchers think it is not suitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Time of complete repair;

Secondary

MeasureTime frame
Vaginal bleeding;Vaginal infections;

Countries

China

Contacts

Public ContactFan Jiaying

Guangzhou Women and Children's Medical Center

fanjiaying@gwcmc.org+86 13527721758

Outcome results

None listed

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