Assessing the Effects of Air-cooling on Capillary Malformations

November 25, 2012 updated by: Dr Irving Ling, National Health Service, United Kingdom

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • Glasgow, United Kingdom, G4 0SF
        • Canniesburn Plastic Surgery Unit, Glasgow Royal Infirmary
        • Principal Investigator:
          • Irving Ling, MBBS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Capillary Malformation identified through our department database

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients less than 16 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Capillary malformation
Device: Air cooling to CM site

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To study the effects of cutaneous air cooling on blood vessel diameter in capillary malformation
Time Frame: 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.
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Anticipated)

November 1, 2013

Study Completion (Anticipated)

November 1, 2013

Study Registration Dates

First Submitted

November 24, 2012

First Submitted That Met QC Criteria

November 25, 2012

First Posted (Estimate)

November 28, 2012

Study Record Updates

Last Update Posted (Estimate)

November 28, 2012

Last Update Submitted That Met QC Criteria

November 25, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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