- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01176877
Assessing and Improving Patient Knowledge About Keloid Scars (Keloids)
November 30, 2012 updated by: Roopal Kundu, Northwestern University
Assessing and Improving Patient Knowledge About Keloids
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Keloids scars differ from other scar types in that they grow beyond the borders of the injury that caused them.
Patients with darker pigmented skin are more likely to develop keloids, and blacks are especially predisposed to keloid formation.
Treatment options for keloids are limited in that new keloids often form at the treated location.
The limited efficacy of professional treatment options and the harmless appearance of small keloid scars may lead a patient to try to manage their keloid scars on their own.
One source of information that patients may turn to for self-treatment advice is the Internet.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern University Feinberg School of Medicine, Department of Dermatology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects with a clinical diagnosis of keloid scarring
- Subjects over the age of 18
Exclusion Criteria:
- That which does not fit the inclusion criteria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: keloid scar
Those with a diagnosis of keloid scar.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: immediately before and after a 5 minute 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: before and 3 months after a 5 minute 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.
|
before and 3 months after a 5 minute educational lecture
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Roopal V Kundu, MD, Northwestern University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Juckett G, Hartman-Adams H. Management of keloids and hypertrophic scars. Am Fam Physician. 2009 Aug 1;80(3):253-60.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2010
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
July 30, 2010
First Submitted That Met QC Criteria
August 4, 2010
First Posted (Estimate)
August 6, 2010
Study Record Updates
Last Update Posted (Estimate)
January 3, 2013
Last Update Submitted That Met QC Criteria
November 30, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU32316
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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