Keloid ScarNCT01176877
Assessing and Improving Patient Knowledge About Keloid Scars (Keloids)
A study testing Scripted lecture ("educational information talk") in people with Keloid Scar, run by Northwestern University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keloid Scar
- What is being tested?
- Scripted lecture ("educational information talk")
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Sep 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with a clinical diagnosis of keloid scarring
- Subjects over the age of 18
Who cannot join
- That which does not fit the inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, 60611
About this study
Official title: 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
Read the 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.
- Conditions
- Keloid Scar
- Being tested
- Scripted lecture ("educational information talk")
- Medical subject headings
- Keloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scripted lecture ("educational information talk")Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| keloid scar | Other | Those with a diagnosis of keloid scar. Receives: Behavioral: Scripted lecture ("educational information talk") |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: before and 3 months after a 5 minute educational lecture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Keloid ScarStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roopal Kundu, Northwestern University
- Investigators
- Roopal V Kundu, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01176877
- Sponsor's protocol ID
- STU32316
- Status last verified
- Nov 2012
- First submitted
- 30 Jul 2010
- Last updated
- 3 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Juckett G, Hartman-Adams H. Management of keloids and hypertrophic scars. Am Fam Physician. 2009 Aug 1;80(3):253-60.
PubMed 19621835Sclafani 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.
PubMed 8646474Shaffer 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.
PubMed 11807470Shinchuk 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.
PubMed 19966558
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing and Improving Patient Knowledge About Keloids
- ClinicalTrials.gov ID
- NCT01176877
- Acronym / sponsor ID
- STU32316
- Conditions
- Keloid Scar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 6 Aug 2010 (estimated)
- Results
- Posted 3 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| keloid scar | Other | Behavioral: Scripted lecture ("educational information talk")Those with a diagnosis of keloid scar. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects with a clinical diagnosis of keloid scarring
- Subjects over the age of 18
Key exclusion criteria (1 listed)
- That which does not fit the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scripted lecture ("educational information talk")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. | Behavioural | keloid scar |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19621835Juckett G, Hartman-Adams H. Management of keloids and hypertrophic scars. Am Fam Physician. 2009 Aug 1;80(3):253-60.
- Background: PubMed 8646474Sclafani 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.
- Background: PubMed 11807470Shaffer 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.
- Background: PubMed 19966558Shinchuk 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.
- Northwestern University Department of Dermatology Actively Enrolling Research TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roopal V Kundu, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scripted lecture ("educational information talk") in people with Keloid Scar, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01176877, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2013.