Assessing the Effects of Air-cooling on Capillary Malformations

Laser Clinical Trial

Official title:

An Observational Study as to the Effects of Cutaneous Air-cooling on Blood Vessel Diameter in Capillary Malformations

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01735734
• Other study ID #: GN
• Status: Not yet recruiting
• Phase: N/A
• First received: November 24, 2012
• Last updated: November 25, 2012
• Start date: February 2013
• Est. completion date: November 2013

Study information

• Verified date: November 2012
• Source: National Health Service, United Kingdom
• Contact: Irving Ling, MBBS
• Email: irvingling[@]nhs.net
• Is FDA regulated: No
• Health authority: United Kingdom: National Health ServiceUnited Kingdom: National Institute for Health ResearchUnited Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

The purpose of this observational study is to ascertain the effects of cutaneous air cooling on vessel diameter within Capillary Malformations (CM).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 35
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Adult more than 16 years of age

• Patient diagnosed with Capillary Malformation

Exclusion Criteria:

• Patients less than 16 years of age

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Capillary Malformation
• Congenital Abnormalities
• Laser
• Port-Wine Stain
• Skin Cooling
• Vascular Malformations

Intervention

Device:
• Air cooling to CM site

Locations

Country	Name	City	State
United Kingdom	Canniesburn Plastic Surgery Unit, Glasgow Royal Infirmary	Glasgow

Sponsors (1)

Lead Sponsor	Collaborator
National Health Service, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To study the effects of cutaneous air cooling on blood vessel diameter in capillary malformation	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.	10 minutes	No