Viewing Study NCT04856605



Ignite Creation Date: 2024-05-06 @ 4:04 PM
Last Modification Date: 2024-10-26 @ 2:02 PM
Study NCT ID: NCT04856605
Status: COMPLETED
Last Update Posted: 2024-03-06
First Post: 2021-04-14

Brief Title: Umblical Pilonidal Sinus Evaluation
Sponsor: Istanbul Medeniyet University
Organization: Istanbul Medeniyet University

Study Overview

Official Title: The Factors Associated With Occurrence and Healing Of Umbilical Pilonidal Sinus Disease
Status: COMPLETED
Status Verified Date: 2024-03
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: Purpose Pilonidal sinus disease PSD is a chronic inflammatory condition of skin due to implanted loose hair PSD is commonly seen in sacrococcygeal region but can also be seen in axilla perineum suprapubic regions on hands and umbilicus The aim of this project was to find factors influencing the development and treatment of umbilical pilonidal sinus

Material and methods In this cross-sectional prospective study the investigators evaulated 82 19 female 63 male patients with a history of umbilical pilonidal disease eg predisposing factors treatment modalities between 2012 and 2020
Detailed Description: In this study participants were volunteer patients admitted to Erzincan University Medical Faculty to the General Surgery Outpatient Clinic between March of 2012 and December of 2020 with umbilical symptoms such as umbilical discharge and umbilical pain All patients were diagnosed by physical examination confirmed with ultrasonography Patients with diseases other than umbilical sinus were excluded from the study Examined patients characteristics include age gender intergluteal sinus disease history family history belly shaving histoy daily shower treatment modality and healing status There were 3 treatment modalities conservative approach daily shower shaving antibitics if infected topical silver nitrate treatment surgical operation for umbilical sinus as excracting the hairs from the sinus excising the sinus To determine if healed the investigators followed up our patients ensuring no symptoms for a minimum 2 years

Chi-square tests were conducted to compare the distribution of categorical variables Age was analyzed as a continuous variable with a t-test Univariable and multivariable logistic regression models were used to calculate odds ratios and 95 confidence intervals P-values of less than 005 were considered statistically significant Statistical analyses were conducted with R version of 361 R Foundation for Statistical Computing Vienna Austria httpswwwr-projectorg software packages

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