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

Not Applicable

Recruiting

• Conditions: Not Applicable

• Registration Number: KCT0002026
• Lead Sponsor: The Catholic University of Korea, Seoul St. Mary's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 98

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

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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
sensation of periauricular area;questionnaire for quality of life

Secondary Outcome Measures

Name	Time	Method
postoperative amount of bleeding