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Evaluation and Comparison of Keloids and Second Degree Burns Blisters Fluid

This study is currently recruiting participants.
Verified February 2017 by Yaron Har-Shai, Carmel Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01627769
First Posted: June 26, 2012
Last Update Posted: February 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Yaron Har-Shai, Carmel Medical Center
  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: Observational Model: Other
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:


Further study details as provided by Yaron Har-Shai, 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. ]

    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 Following the results of the above study a further extension of the study is progressing in which the identification of the cell population in the blister fluid following intralesional cryosurgery of keloid scars is examined

Estimated Enrollment: 20
Study Start Date: July 2012
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: June 2018 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Yaron Har-Shai, Professor, Carmel Medical Center
ClinicalTrials.gov Identifier: NCT01627769     History of Changes
Other Study ID Numbers: CMC-12-0050-CTIL
First Submitted: June 22, 2012
First Posted: June 26, 2012
Last Update Posted: February 16, 2017
Last Verified: February 2017

Keywords provided by Yaron Har-Shai, Carmel Medical Center:
scars
blisters
second degree burns
cryosurgery
keloid scars
hypertrophic scars

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