Assessing the Effects of Air-cooling on Capillary Malformations

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2012 by National Health Service, United Kingdom
Sponsor:
Information provided by (Responsible Party):
Dr Irving Ling, NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier:
NCT01735734
First received: November 24, 2012
Last updated: November 25, 2012
Last verified: November 2012
  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 National Health Service, United Kingdom:

Primary Outcome Measures:
  • To study the effects of cutaneous air cooling on blood vessel diameter in capillary malformation [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: November 24, 2012
Last Updated: November 25, 2012
Health Authority: United Kingdom: National Health Service
United Kingdom: National Institute for Health Research
United Kingdom: Research Ethics Committee

Keywords provided by National Health Service, United Kingdom:
Skin disease
Capillary Malformation
Laser therapy

Additional relevant MeSH terms:
Congenital Abnormalities
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014