The Efficacy of Gentamicin-impregnated collagen (Collatamp®) in the Loop Electrosurgical Excision Procedure

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0005096

Enrollment

Registered

2020-06-08

Start date

2019-11-29

Completion date

Unknown

Last updated

2020-06-15

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

Conditions

None listed

Interventions

Drug : LEEP is performed in the operating room under MAC (Monitored Anesthesia Care) anesthesia. The range to be removed by the Loop electrodes is determined by the distribution of lesions. We send bi

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: - biopsy proven, persistent LSIL or HSIL - biopsy proven CIN II or III - undergoing diagnostic leep in case of an abnormal pap smear result

Exclusion criteria

Exclusion criteria: - In case of pregnancy - Undiagnosed uterine and vaginal bleeding - Past history of the previous LEEP - Invasive cancer - Hypersensitivity to Gentamycin

Design outcomes

Primary

Measure	Time frame
vaginal beeding;vaginal discharge;infection	—

Secondary

Measure	Time frame
Abdominal pain (Visual analogue scale);Colposcopy	—

Countries

Korea, Republic of

Contacts

Public ContactMi Park

Chungnam National University Hospital

Outcome results