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Assessing the Effects of Air-cooling on Capillary Malformations

NCT ID: NCT01735734

Last Updated: 2012-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Capillary Malformation Laser Skin Cooling

Keywords

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Skin disease Capillary Malformation Laser therapy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Capillary malformation

Air cooling to CM site

Intervention Type DEVICE

Interventions

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Air cooling to CM site

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patients less than 16 years of age
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Health Service, United Kingdom

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr Irving Ling

Academic Foundation Doctor, Honorary Clinical Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Irving Ling, MBBS

Role: PRINCIPAL_INVESTIGATOR

NHS Greater Glasgow and Clyde

Adam Gilmour, MBChB, MRCS (Ed)

Role: STUDY_CHAIR

NHS Greater Glasgow and Clyde

Iain Mackay, MBChb, MRCS, FRCS (plast)

Role: STUDY_DIRECTOR

NHS Greater Glasgow and Clyde

Locations

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Canniesburn Plastic Surgery Unit, Glasgow Royal Infirmary

Glasgow, , United Kingdom

Site Status

Countries

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United Kingdom

Central Contacts

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Irving Ling, MBBS

Role: CONTACT

Email: [email protected]

Other Identifiers

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GN

Identifier Type: -

Identifier Source: org_study_id