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Retrospective Study of Keloid Disorder

Retrospective Study of Keloid Disorder

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02923596
Enrollment
5000
Registered
2016-10-04
Start date
2016-09-30
Completion date
2023-09-30
Last updated
2016-10-04

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

Conditions

Keloid

Keywords

Keloid

Brief summary

Purpose of this retrospective study is to review and analyze the information and data that has been already been generated during the course of routine practice of medicine by the investigators from 2007 up until Sept 1, 2016 from keloid patients who have sought medical care or medical advice for their keloid disorder.

Detailed description

To retrospectively review and analyze clinical data that has already been collected from keloid patients including photographs taken of keloid lesions during routine practice of medicine by the investigators 1) To better understand natural history of keloid disorder (KD), 2)To determine the ethnic incidence and prevalence of keloid, 3) To determine the rate of familial keloids, 4) To determine response to different treatment modalities, 5) To determine risk factors for development and worsening of keloid lesions.

Interventions

PROCEDUREHistory of prior Surgery

History of prior Surgery will be reviewed

RADIATIONHistory of Radiation Therapy

History of prior radiation therapy will be reviewed

Sponsors

Tirgan, Michael H., M.D.
Lead SponsorINDIV

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* All patients must have at least one keloid lesion. * Availability of photographic documentation of keloid lesion(s).

Exclusion criteria

* Lack of photographic documentation of keloid lesion(s) * Lack of demographic data

Design outcomes

Primary

MeasureTime frameDescription
Rate of development of massive, semi-massive and large Keloids1-5 years after surgeryKeloid Recurrence after surgery is a real-world outcome, one that takes time to develop. Study will intend to explore the long term rate of keloid recurrence after surgery. This rate will be reported as percentage of patients who undergo surgery and end up with developing a massive, semi-massive or large recurrent keloid

Secondary

MeasureTime frameDescription
Rate of poor aesthetic outcome after ear surgery1-5 years after surgerySurgical intervention often results in loss of ear tissue and poor aesthetic outcome. Although fully expected, the actual rates of this outcome is unknown. Study intends to report the actual rate of disfigurement and poor aesthetic outcome after ear surgery for removal of keloid lesions.

Countries

United States

Contacts

Primary ContactMichael H Tirgan, MD
htirgan@gmail.com212 874 4200

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026