Retrospective Study of Keloid Disorder

NCT02923596 | Unknown

• 1 other identifier: Tirgan 16-01
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Keloid

Keywords

Keloid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Rate of poor aesthetic outcome after ear surgery

  1-5 years after surgery

Study Arms (3)

Patients with Ear Keloids

Records of Patients with Ear Keloids will be reviewed. Data and photographs will be analysed.

Procedure: History of prior Surgery; Radiation: History of 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; Radiation: History of 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; Radiation: History of Radiation Therapy

Interventions

History of prior Surgery PROCEDURE

History of prior Surgery will be reviewed

Also known as: Surgery

Patients with Ear Keloids; Patients with Neck Keloids; Patients with Scalp Keloids

History of Radiation Therapy RADIATION

History of prior radiation therapy will be reviewed

Also known as: Radiation Therapy

Patients with Ear Keloids; Patients with Neck Keloids; Patients with Scalp Keloids

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients with a diagnosis of keloid

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tirgan, Michael H., M.D.: lead

Study Sites (2)

Michael H. Tirgan MD

New York, New York, 10024, United States

RECRUITING

Texas Institute of Dermatology

San Antonio, Texas, 78257, United States

RECRUITING

MeSH Terms

Conditions

Keloid

Interventions

Surgical Procedures, Operative; Radiotherapy

Condition Hierarchy (Ancestors)

Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Michael H Tirgan, MD

  Keloid Research Foundation

  STUDY CHAIR

Central Study Contacts

Michael H Tirgan, MD

CONTACT

212 874 4200; htirgan@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2016
• First Posted: October 4, 2016
• Study Start: September 1, 2016
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2023
• Last Updated: October 4, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

US (2)