Evaluation and Comparison of Keloids and Second Degree Burns Blisters Fluid

NCT01627769 | Unknown DMC

• 1 other identifier: CMC-12-0050-CTIL
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Blisters; Second Degree Burns; Wounds

Keywords

scars; blisters; second degree burns; cryosurgery; keloid scars; hypertrophic scars

Outcome Measures

Primary Outcomes (1)

• comparison of inflamation cells and proteins (proteomic evaluation) between blisters caused by heat and blisters caused by cryo injury

  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.

  at time of sampling.

Study Arms (2)

second degree blisters patients

blister fluids of second degree burns

cryotherapy blisters

blister fluids of cryosurgery wounds

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• subject agrees to enroll in the research
• subject provides written authorization for use and disclosure of protected health information
• subject provides written informed consent
• 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
• 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

You may not qualify if:

• subject who has a blister exudate that is culture positive
• subject who has any signs of infection in and/or around the blister
• subject with blisters present more then 24 hours (after which samples will not be taken)

Sponsors & Collaborators

• Carmel Medical Center: lead

Study Sites (1)

Carmel Medical Center

Haifa, Haifa District, Israel

RECRUITING

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

MeSH Terms

Conditions

Blister; Wounds and Injuries; Cicatrix; Keloid; Cicatrix, Hypertrophic

Condition Hierarchy (Ancestors)

Skin Diseases, Vesiculobullous; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Fibrosis; Pathologic Processes; Collagen Diseases; Connective Tissue Diseases

Study Officials

• yaron har-shai, Md

  carmel medical center- ISRAEL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yaron har-shai, Md

CONTACT

050-7866206; yaron07@yahoo.com

nir gal or, Md

CONTACT

054-5454636; nirgalor@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 22, 2012
• First Posted: June 26, 2012
• Study Start: July 1, 2012
• Primary Completion: June 1, 2018
• Study Completion: July 1, 2018
• Last Updated: February 16, 2017

Record last verified: 2017-02

Locations

IL (1)