Assessing the Effects of Air-cooling on Capillary Malformations
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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 |
- 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 |
Patients with Capillary Malformation identified through our department database
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| Contact: Irving Ling, MBBS | irvingling@nhs.net |
| United Kingdom | |
| Canniesburn Plastic Surgery Unit, Glasgow Royal Infirmary | Not yet recruiting |
| Glasgow, United Kingdom, G4 0SF | |
| Principal Investigator: Irving Ling, MBBS | |
| 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 Port-Wine Stain Skin Abnormalities Skin Diseases |
ClinicalTrials.gov processed this record on May 23, 2013