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Completed

NCT Number: NCT04856605

Umblical Pilonidal Sinus Evaluation

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 (e.g. predisposing factors, treatment modalities) between 2012 and 2020.

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Key information

Age range

15 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

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 0.05 were considered statistically significant. Statistical analyses were conducted with R version of 3.6.1 (R Foundation for Statistical Computing, Vienna, Austria, https://www.r-project.org) software packages.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all patients with umblical pilonidal sinus

Exclusion criteria

  • no disease

Treatment and study plan

Surgery

Procedure

regular surgery

Primary outcomes

  1. healing status

    Time frame: 2 year

    to define the best method for healing. It will be measured by the duration(days) of healing.

Secondary outcomes

  1. recurrence status

    Time frame: 2 year

    to define the best method for recurrence prevention. Recurrence will be noted as purulent discharge over the umblicus.

Other outcomes

  1. duration of wound healing

    Time frame: 2 year

    The investigators will measure the diameter(cm) of the wound everyday.

Sponsors and collaborators

Lead sponsor

Istanbul Medeniyet University

Other

Registry information

Official study title

The Factors Associated With Occurrence and Healing Of Umbilical Pilonidal Sinus Disease

Important dates

Study start
2012
Primary completion
2020
Study completion
2020
First posted
Apr 23, 2021
Registry last updated
Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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