Viewing Study NCT04512664



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Last Modification Date: 2024-10-26 @ 1:42 PM
Study NCT ID: NCT04512664
Status: COMPLETED
Last Update Posted: 2020-08-13
First Post: 2019-11-25

Brief Title: Different Cold Application Times on Ecchmosis Edema and Pain After Rhinoplasty
Sponsor: University of Beykent
Organization: University of Beykent

Study Overview

Official Title: Principal Investigator
Status: COMPLETED
Status Verified Date: 2020-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The aim of this study is to investigate the effects of different cold application times with cold gel pads after rhinoplasty on eyelid edema eye ecchymosis and pain A total of 60 patients undergoing rhinoplasty were divided into two groups by simple randomization method Cold application applied to short term group for 4 hours and to long term group for 48 hours Cold application was applied around both eyes with cold gel pads for 20 minutes per hour Pain was evaluated with the Visuel Analog Scale ecchymosis with eyelid ecchymosis score and edema with eye-edema score Edema and ecchymosis were evaluated on the 1st and 4th hours and 2nd day Pain conditions were evaluated before and after analgesics for 1 4 hours and 2 times daily
Detailed Description: The research was carried out between January 2015 and March 2017 in an education and research hospital with a capacity of 26 beds The research was suspended between July 2015 and January 2016 Patients who underwent rhinoplasty septorhinoplasty operation between January 2015 and March 2017 with open or closed technique were included in the study The study included patients who were 18 years of age or older who underwent a rhinoplasty septorhinoplasty operation voluntarily Patients who had cold allergy refused to participate applied outside of the research protocol and required re-operation in the early postoperative period due to complications were excluded from the study All patients were provided with training and brochures for preoperative intraoperative and postoperative periods The cold application was done with gel pads of the same size and weight 13 cm x 13 cm-approximately 100 g for 20 minutes per hour Cold application was performed by the researcher in both groups for the first 4 hours The patients in the short-term cold application group were given cold application by the researcher for 4 hours and 20 minutes per hour and the cold application was terminated In the long-term application group the first 4 hours of cold application were done by the researcher Cold application after 4 hours jel pads was applied at home by the patients relative in accordance with the training given on the cold application protocol

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None