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Evaluation and Comparison of Keloids and Second Degree Burns Blisters Fluid

This study is currently recruiting participants.
Verified February 2013 by Carmel Medical Center
Sponsor:
Information provided by (Responsible Party):
Yaron Har-Shai, Carmel Medical Center
ClinicalTrials.gov Identifier:
NCT01627769
First received: June 22, 2012
Last updated: February 14, 2013
Last verified: February 2013
History of Changes
  Purpose

It is well documented that following thermal burns injury the development of hypertrophic scars and keloid (HSK) ranges between 40 to 90%. on the other hand It is well documented that cryosurgery wounds generally heal with minimal tissue contraction, resulting in good cosmetic results and with minimal complications.

The Aim of the study is To specify the burn and cryosurgery blister fluid for proteins, cytokines and cells and To compare between the above data regarding possible proteins, cytokines and cells, in regard to their possible effect on scarring and wound healing.

Also to Identify those components which are present only in the cryosurgery blister and which might have an anti-scarring effect and to characterize them biochemically.


Condition
Blisters
Second Degree Burns
Wounds

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Comparison of the Blister Fluid Components of Second Degree Burned Patients With the Blister Fluid Components Following Intralesional Cryosurgery of Keloid Scars - A Feasibility Study.

Resource links provided by NLM:

MedlinePlus related topics: Burns Scars
U.S. FDA Resources

Further study details as provided by Carmel Medical Center:

Primary Outcome Measures:
  • comparison of inflamation cells and proteins (proteomic evaluation) between blisters caused by heat and blisters caused by cryo injury [ Time Frame: at time of sampling. ] [ Designated as safety issue: No ]

    the protein evaluation and comparison is achieved by the use of proteomic study which evaluate the quantity of about 700 different proteins in the fluid of the different blisters (heat blisters compared to "cryo" blisters).

    we also evaluate the differences in quntities between the inflamation cells in each sample.



Biospecimen Retention:   Samples With DNA

blister fluid of kryosurgery and second degree burns


Estimated Enrollment: 20
Study Start Date: July 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
second degree blisters patients
blister fluids of second degree burns
cryotherapy blisters
blister fluids of cryosurgery wounds

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

patients with second degree burns patients status post cryosurgery treatment for keloid scars with post treatment blisters

Criteria

Inclusion Criteria:

  1. subject agrees to enroll in the research
  2. subject provides written authorization for use and disclosure of protected health information
  3. subject provides written informed consent
  4. subject who suffer a second degree burn with intact blisters from hot water or liquid within 24 hours, and have been admitted to the emergency room at Carmel Medical center
  5. subject suffering from keloids and are treated at the Department of Plastic Surgery , Linn Medical Center, by the intralesional cryosurgery method within the last 24 hours and have developed an intact blister

Exclusion Criteria:

  1. subject who has a blister exudate that is culture positive
  2. subject who has any signs of infection in and/or around the blister
  3. subject with blisters present more then 24 hours (after which samples will not be taken)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01627769

Contacts
Contact: yaron har-shai, Md 050-7866206 yaron07@yahoo.com
Contact: nir gal or, Md 054-5454636 nirgalor@gmail.com

Locations
Israel
Carmel Medical Center Recruiting
Haifa, Israel
Contact: yaron har-shai, Md     050-7866206     yaron07@yahoo.com    
Contact: nir gal or, Md     054-5454636     nirgalor@gmail.com    
Principal Investigator: yaron har-shai, Md            
Sponsors and Collaborators
Carmel Medical Center
Investigators
Principal Investigator: yaron har-shai, Md carmel medical center- ISRAEL
  More Information

No publications provided

Responsible Party: Yaron Har-Shai, Professor, Carmel Medical Center
ClinicalTrials.gov Identifier: NCT01627769     History of Changes
Other Study ID Numbers: CMC-12-0050-CTIL
Study First Received: June 22, 2012
Last Updated: February 14, 2013
Health Authority: Israel: Ethics Commission

Keywords provided by Carmel Medical Center:
scars
blisters
second degree burns
 cryosurgery
keloid scars
hypertrophic scars

Additional relevant MeSH terms:
Blister
Burns
Keloid
Skin Diseases, Vesiculobullous
Skin Diseases
Pathological Conditions, Anatomical
 Wounds and Injuries
Collagen Diseases
Connective Tissue Diseases
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013