NCT01176877

Brief Summary

The purpose of this study is:

  • to identify how knowledge about keloid scars and self-treatments differs between patients who use the Internet as a source of information and patients who do not
  • to determine if patients who are at a high risk of developing additional keloid scars are more or less likely to change their behavior based on an educational information talk about keloid scar prevention

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2010

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 6, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

January 3, 2013

Completed
Last Updated

January 3, 2013

Status Verified

November 1, 2012

Enrollment Period

1.1 years

First QC Date

July 30, 2010

Results QC Date

August 29, 2012

Last Update Submit

November 30, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • To Assess the Impact of an Educational Lecture on Knowledge About Keloid Scars by Comparing Mean Scores Between Knowledge Assessment Questionnaires Administered Before an Educational Lecture and Immediately After an Educational Lecture

    All subjects completed a written questionnaire to assess knowledge about keloid scars before an educational lecture about keloids, immediately after the educational lecture about keloids, and 3 months after the educational lecture about keloids. This written questionnaire to assess knowledge about keloid scars contained 19 questions related to risk factors for developing keloid scars, keloid scar prevention, and keloid scar treatment. A correct response to a question was awarded 1 point and all correct responses were summed to achieve a total score. Possible total score ranged from 0 to 19. A score of 0 is associated with worse knowledge about keloid scars and a score of 19 is associated with better knowledge about keloid scars.

    immediately before and after a 5 minute educational lecture

Secondary Outcomes (1)

  • To Assess the Impact of an Educational Lecture on Long-term Knowledge Retention About Keloid Scars by Comparing Mean Scores Between Knowledge Assessment Questionnaires Administered Before an Educational Lecture and 3 Months After an Educational Lecture

    before and 3 months after a 5 minute educational lecture

Study Arms (1)

keloid scar

OTHER

Those with a diagnosis of keloid scar.

Behavioral: Scripted lecture ("educational information talk")

Interventions

This scripted lecture will be approximately 5 minutes in length and will include 3 picture examples of keloid and hypertrophic scarring as well as an opportunity to ask questions.

keloid scar

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with a clinical diagnosis of keloid scarring
  • Subjects over the age of 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, 60611, United States

Location

Related Publications (4)

  • Juckett G, Hartman-Adams H. Management of keloids and hypertrophic scars. Am Fam Physician. 2009 Aug 1;80(3):253-60.

    PMID: 19621835BACKGROUND
  • Sclafani AP, Gordon L, Chadha M, Romo T 3rd. Prevention of earlobe keloid recurrence with postoperative corticosteroid injections versus radiation therapy: a randomized, prospective study and review of the literature. Dermatol Surg. 1996 Jun;22(6):569-74. doi: 10.1111/j.1524-4725.1996.tb00376.x.

    PMID: 8646474BACKGROUND
  • Shaffer JJ, Taylor SC, Cook-Bolden F. Keloidal scars: a review with a critical look at therapeutic options. J Am Acad Dermatol. 2002 Feb;46(2 Suppl Understanding):S63-97. doi: 10.1067/mjd.2002.120788.

    PMID: 11807470BACKGROUND
  • Shinchuk LM, Chiou P, Czarnowski V, Meleger AL. Demographics and attitudes of chronic-pain patients who seek online pain-related medical information: implications for healthcare providers. Am J Phys Med Rehabil. 2010 Feb;89(2):141-6. doi: 10.1097/PHM.0b013e3181c56938.

    PMID: 19966558BACKGROUND

Related Links

MeSH Terms

Conditions

Keloid

Condition Hierarchy (Ancestors)

Collagen DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesCicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

limitation of the study is the accrual of a majority of participants from keloid patients at a single academic center.

Results Point of Contact

Title
Dr. Steven Nwe, Clinical Research Fellow
Organization
Northwestern University, Feinberg School of Medicine, Department of Dermatology

Study Officials

  • Roopal V Kundu, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Dermatology

Study Record Dates

First Submitted

July 30, 2010

First Posted

August 6, 2010

Study Start

August 1, 2010

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

January 3, 2013

Results First Posted

January 3, 2013

Record last verified: 2012-11

Locations