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Assessing the Effects of Air-cooling on Capillary Malformations

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2012 by Dr Irving Ling, NHS Greater Glasgow and Clyde.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01735734
First Posted: November 28, 2012
Last Update Posted: November 28, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr Irving Ling, NHS Greater Glasgow and Clyde
  Purpose
The purpose of this observational study is to ascertain the effects of cutaneous air cooling on vessel diameter within Capillary Malformations (CM).

Condition Intervention
Capillary Malformation Laser Skin Cooling Device: Air cooling to CM site

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: An Observational Study as to the Effects of Cutaneous Air-cooling on Blood Vessel Diameter in Capillary Malformations

Resource links provided by NLM:


Further study details as provided by Dr Irving Ling, NHS Greater Glasgow and Clyde:

Primary Outcome Measures:
  • To study the effects of cutaneous air cooling on blood vessel diameter in capillary malformation [ Time Frame: 10 minutes ]
    In a temperature controlled room, the participant's capillary diameter/depth and skin/core temperatures will be taken from their CM prior to cooling the skin. The patients' CM will be cooled for a duration of 1 minute. The above measurements will be repeated immediately after 1 minute of cooling.


Estimated Enrollment: 35
Study Start Date: February 2013
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Capillary malformation Device: Air cooling to CM site

Detailed Description:
Capillary malformation (CM) is the most common vascular malformation occurring in approximately 0.3% of all newborn. The standard treatment for facial or aesthetically sensitive CM's is flashlamp Pulsed Dye Laser. Skin cooling prior to laser treatment of CMs is standard practice within our department. The effects of skin cooling on the vasculature within CMs are poorly understood. Previous studies by our department have shown that raising ambient temperature increases CM vessel size. It has been postulated that by increasing CM vessel size, it may also increase the effectiveness of treatment. We hypothesize that cooling the skin during laser treatment may cause vasconstriction of the superficial vessels within the CM. This may have an impact on treatment success.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with Capillary Malformation identified through our department database
Criteria

Inclusion Criteria:

  • Adult more than 16 years of age
  • Patient diagnosed with Capillary Malformation

Exclusion Criteria:

  • Patients less than 16 years of age
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01735734


Contacts
Contact: Irving Ling, MBBS irvingling@nhs.net

Locations
United Kingdom
Canniesburn Plastic Surgery Unit, Glasgow Royal Infirmary Not yet recruiting
Glasgow, United Kingdom, G4 0SF
Principal Investigator: Irving Ling, MBBS         
Sponsors and Collaborators
National Health Service, United Kingdom
Investigators
Principal Investigator: Irving Ling, MBBS NHS Greater Glasgow and Clyde
Study Chair: Adam Gilmour, MBChB, MRCS (Ed) NHS Greater Glasgow and Clyde
Study Director: Iain Mackay, MBChb, MRCS, FRCS (plast) NHS Greater Glasgow and Clyde
  More Information

Responsible Party: Dr Irving Ling, Academic Foundation Doctor, Honorary Clinical Fellow, NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT01735734     History of Changes
Other Study ID Numbers: GN
First Submitted: November 24, 2012
First Posted: November 28, 2012
Last Update Posted: November 28, 2012
Last Verified: November 2012

Keywords provided by Dr Irving Ling, NHS Greater Glasgow and Clyde:
Skin disease
Capillary Malformation
Laser therapy

Additional relevant MeSH terms:
Congenital Abnormalities
Port-Wine Stain
Vascular Malformations
Skin Abnormalities
Skin Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases