Assessing the Effects of Air-cooling on Capillary Malformations

• Conditions: Capillary Malformation; Skin Cooling; Laser
• Interventions: Device: Air cooling to CM site

• Registration Number: NCT01735734
• Lead Sponsor: National Health Service, United Kingdom

Brief Summary

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

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.

Study Timeline

• Status Verified: 2012-11
• Study First Submitted: 2012-11-24
• Study First Submitted QC: 2012-11-25
• Last Update Submitted: 2012-11-25
• Study First Posted: 2012-11-28
• Last Update Posted: 2012-11-28
• Study Start: 2013-02
• Primary Completion: 2013-11
• Study Completion: 2013-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Capillary malformation	Air cooling to CM site	-

Primary Outcome Measures

Name	Time	Method
To study the effects of cutaneous air cooling on blood vessel diameter in capillary malformation	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.

Trial Locations

Locations (1)

Canniesburn Plastic Surgery Unit, Glasgow Royal Infirmary; 🇬🇧 Glasgow, United Kingdom