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A clinical test on the safety and effect on periauricular sensation of a CPCG500 in patients who underwent parotidectomy: prospective, multicenter, randomized double-blind study

The safety and effectiveness of a CPCG500 on periaruicular sensation in patients who underwent parotidectomy: prospective, multicenter, randomized double-blind study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0002026
Enrollment
98
Registered
2016-08-26
Start date
2016-09-14
Completion date
Unknown
Last updated
2019-03-11

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

Conditions

None listed

Interventions

Drug : For the patients of the study group, an commercial anti-adhesive agent GCP500(Mediclo) is applied around the greater auricular nerve after the parotidectomy. For the patients of the control gro

Sponsors

The Catholic University of Korea, Seoul St. Mary's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Subject who satisfy all the conditions below 1) Age between 20 and 80 male or female 2) Patients who are planned to undergo parotidectomy 3) Patients who agree to participate in the study spontaneously and receive written consent.

Exclusion criteria

Exclusion criteria: Subject who satisfy at least one condition below 1) Patients who undergo bilateral parotidectomy 2) Patients who are diagnosed as malignant tumor before or after the surgery 3) Patients who have a history of chemotherapy or radiation therapy 4) Patients who have trauma history near the auricle 5) Patients who have central/peripheral nervous disorders or psychiatric diseases 6) Pregnant or lactating women. Patients who are planning to be pregnant during the period of study 7) Patients who have taken other medicines or medical devices by participating another clinical trials 8) Patients who are considered to be improper by the examiner

Design outcomes

Primary

MeasureTime frame
sensation of periauricular area;questionnaire for quality of life

Secondary

MeasureTime frame
postoperative amount of bleeding

Countries

Korea, Republic of

Contacts

Public ContactInn-chul Nam

The Catholic University of Korea, Incheon St. Mary's Hospital

Outcome results

None listed

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