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Contact Information:

Mr NSM Moiemen


Study Location:

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Be Part of Research - Trial Details - Investigation of dermal metabolism in burned and unburned human skin using the microdialysis method to quantify peripheral resuscitation following burn injury

Investigation of dermal metabolism in burned and unburned human skin using the microdialysis method to quantify peripheral resuscitation following burn injury

Not Recruiting

Open to: All Genders

Age: Adult

Medical Conditions

Burn injury


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Not provided at time of registration

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

02 Feb 2006 02 Feb 2008

Interventional

Intervention Type : Other
Intervention Description : Three studies are proposed:

Study 1: Normal Volunteers -12 healthy volunteers will be recruited. Each volunteer will be asked to attend the Burns Unit for a 4-hour period at their convenience. Once informed consent is obtained, a topical anaesthetic cream will be applied to a site on the forearm. This will be left in place for 30 minutes until anaesthesia has been achieved. The skin will be cleaned, and a microdialysis probe inserted into the skin using a needle (1.4 mm diameter). The needle is the same size as a standard intravenous cannula. The needle and the probe are sterile. The needle will be removed and the flexible probe left in the skin. This will be secured in place with tape. The probe is connected to a small pump, the size of a mobile phone. This pumps sterile, neutral fluid at a very low rate through the probe (less than 1ml per hour), and a sample is collected from the other end of the probe into a small plastic vial which will be changed every 10 minutes. After placement, the volunteer will be asked to rest for 90 minutes in a room at 20 degrees Celsius. The temperature will then be raised to 30 degrees Celsius for 30 minutes. Following this the room will be cooled to 17 degrees Celsius for 30 minutes. The volunteer will then be asked to exercise on an exercise bicycle for 20 - 30 minutes. The volunteer will then be allowed to rest for 30 minutes. At the end of this period, the probe will be removed, and a small dressing placed over the site. The volunteer will be allowed to leave, and will not be required for further input.

Study 2: Small burns - Twelve patients will be recruited. Any patient admitted to the Burns Unit at Selly Oak Hospital with total burn less than 15% body surface area, and including arm or leg in the burn distribution will be considered for inclusion. Once initial assessment has been completed and therapy commenced, the study will be started. Details of the distribution and depth of the burns will be recorded for correlation with the results. Zone of stasis will be determined by application of a blood pressure cuff on the limb above the burned area. The cuff will be inflated for a maximum of 3 minutes until the zone of stasis is defined. The zone of stasis will be marked with a skin marking pen, then the cuff will be released. A local anaesthetic injection will be given at two of the three areas to be studied: the zone of stasis (as defined above) and the normal area of unburned skin. The zone of coagulation (centre of burn) has no feeling, so anaesthesia is unnecessary. Once anaesthesia is attained (approximately 5 minutes), a microdialysis probe will be placed in the skin at each of these sites. The probe will be perfused with solution via the pump. Dressings will be standardised: Jelonet, gauze and crepe. This is currently the standard dressing for the first 48 hours. Microdialysis samples will be taken every 30 minutes throughout the first 36 hours following injury. Patient activity, medical intervention and events will be noted throughout the study period. Medical notes will also be reviewed subsequent to patient discharge, and events in relation to surgical procedures, skin grafting and wound healing will be noted.

Study 3: Large Burns - Twelve patients will be recruited. Any patient admitted to the Burns Unit or Intensive Care Unit at Selly Oak Hospital with total burn greater than 30% body surface area, will be considered for inclusion. Once initial assessment has been completed and therapy commenced, the study will be started. Details of the distribution and depth of the burns will be recorded for correlation with the results. Zone of stasis will be determined using the cuff method as above. Three microdialysis probes will be inserted under local anaesthesia as above. Samples will be collected every 30 minutes. A gastric probe will be inserted through the nostril to the stomach. This probe is equivalent to the standard nasal feeding tube routinely inserted to feed patients with extensive burn wounds. Measurements are recorded via a bedside machine. Urine samples will be collected every 30 minutes from a standard urinary catheter for measurement of microalbumin. Details of fluid therapy, urine output, gastric tonometry and urine microalbuminuria will be collected and noted. Medical notes will be reviewed subsequent to discharge and surgical procedures, skin grafting, wound healing and patient outcome will be noted. At the end of the 36 hour period, the probes will be removed and the study will be concluded. Patients will receive treatment as per standard protocol in the burns unit. Treatment will not be altered as a result of measurements taken during the study.




You can take part if:



You may not be able to take part if:


Study 1:1.1. Pre-existing skin or other medical conditions (these may interfere with the assessment of normal values)1.2. Alcohol intake in past 6 hours (alcohol may affect metabolism)

Study 2:2.1. Pre-existing skin or other medical conditions2.2. Coexisting trauma (trauma can exacerbate the inflammatory response leading to a false reading)2.3. Alcohol intake in past 6 hours

Study 3:3.1. Pre-existing skin or other medical conditions3.2. Coexisting trauma3.3. Alcohol intake in past 6 hours


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Selly Oak Hospital
    Birmingham
    B29 6JD

This information has not yet been provided by the study team. You'll have an opportunity to discuss any risks and benefits that may be associated with this study prior to consenting to taking part.

Mr NSM Moiemen



The study is sponsored by Record Provided by the NHSTCT Register - 2006 Update - Department of Health and funded by University Hospital Birmingham NHS Trust (UK) - NHS R&D Support Funding.




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Read full details for Trial ID: ISRCTN21069375
Last updated 24 August 2015

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