Retrospective Study of Keloid Disorder

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.

Study Overview

• Status: Recruiting
• Conditions: Keloid
• Intervention / Treatment: Procedure: History of prior Surgery; Radiation: History of Radiation Therapy

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.

• Study Type: Observational
• Enrollment (Anticipated): 5000

Contacts and Locations

• Study Contact: Name: Michael H Tirgan, MD; Phone Number: 212 874 4200; Email: htirgan@gmail.com

Study Locations

• United States
  • New York
    • New York, New York, United States, 10024
      • Recruiting
      • Michael H. Tirgan MD
      • Contact: Michael H Tirgan, MD; Phone Number: 212-874-4200; Email: htirgan@aol.com
      • Principal Investigator: Michael H Tirgan, MD
  • Texas
    • San Antonio, Texas, United States, 78257
      • Recruiting
      • Texas Institute of Dermatology
      • Contact: Reza Ghohestani, MD, PhD; Phone Number: 210-698-6777; Email: ghohestani@gmail.com
      • Principal Investigator: Reza Ghohestani, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients with a diagnosis of keloid

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with Ear Keloids; Records of Patients with Ear Keloids will be reviewed. Data and photographs will be analysed.	Procedure: History of prior Surgery; History of prior Surgery will be reviewed; Other Names: Surgery; Radiation: History of Radiation Therapy; History of prior radiation therapy will be reviewed; Other Names: Radiation Therapy
Patients with Neck Keloids; Records of Patients with Neck area Keloids will be reviewed. Data and photographs will be analysed.	Procedure: History of prior Surgery; History of prior Surgery will be reviewed; Other Names: Surgery; Radiation: History of Radiation Therapy; History of prior radiation therapy will be reviewed; Other Names: Radiation Therapy
Patients with Scalp Keloids; Records of Patients with Scalp Keloids will be reviewed. Data and photographs will be analysed.	Procedure: History of prior Surgery; History of prior Surgery will be reviewed; Other Names: Surgery; Radiation: History of Radiation Therapy; History of prior radiation therapy will be reviewed; Other Names: Radiation Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of development of massive, semi-massive and large Keloids	Keloid 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	1-5 years after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of poor aesthetic outcome after ear surgery	Surgical 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.	1-5 years after surgery

Collaborators and Investigators

• Sponsor: Tirgan, Michael H., M.D.
• Investigators: Study Chair: Michael H Tirgan, MD, Keloid Research Foundation

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: September 12, 2016
• First Submitted That Met QC Criteria: October 1, 2016
• First Posted (Estimate): October 4, 2016

Study Record Updates

• Last Update Posted (Estimate): October 4, 2016
• Last Update Submitted That Met QC Criteria: October 1, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Keloid
• Additional Relevant MeSH Terms: Pathologic Processes; Connective Tissue Diseases; Fibrosis; Cicatrix; Collagen Diseases; Keloid
• Other Study ID Numbers: Tirgan 16-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES