Retrospective Study of Keloid Disorder

• Conditions: Keloid
• Interventions: Procedure: History of prior Surgery; Radiation: History of Radiation Therapy

• Registration Number: NCT02923596
• Lead Sponsor: Tirgan, Michael H., M.D.

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.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-12
• Status Verified: 2016-10
• Study First Submitted QC: 2016-10-01
• Last Update Submitted: 2016-10-01
• Study First Posted: 2016-10-04
• Last Update Posted: 2016-10-04
• Primary Completion: 2022-09
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Ear Keloids	History of Radiation Therapy	Records of Patients with Ear Keloids will be reviewed. Data and photographs will be analysed.
Patients with Ear Keloids	History of prior Surgery	Records of Patients with Ear Keloids will be reviewed. Data and photographs will be analysed.
Patients with Neck Keloids	History of Radiation Therapy	Records of Patients with Neck area Keloids will be reviewed. Data and photographs will be analysed.
Patients with Neck Keloids	History of prior Surgery	Records of Patients with Neck area Keloids will be reviewed. Data and photographs will be analysed.
Patients with Scalp Keloids	History of prior Surgery	Records of Patients with Scalp Keloids will be reviewed. Data and photographs will be analysed.
Patients with Scalp Keloids	History of Radiation Therapy	Records of Patients with Scalp Keloids will be reviewed. Data and photographs will be analysed.

Primary Outcome Measures

Name	Time	Method
Rate of development of massive, semi-massive and large Keloids	1-5 years after surgery	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

Secondary Outcome Measures

Name	Time	Method
Rate of poor aesthetic outcome after ear surgery	1-5 years after 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.

Trial Locations

Locations (2)

Michael H. Tirgan MD; 🇺🇸 New York, New York, United States

Texas Institute of Dermatology; 🇺🇸 San Antonio, Texas, United States