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BlistersNCT01627769

Evaluation and Comparison of Keloids and Second Degree Burns Blisters Fluid

An observational study of Blisters and Second Degree Burns, run by Carmel Medical Center at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Blisters, Second Degree Burns, Wounds
How many people
20 participants
Where
1 siteIsrael
Study dates
Jul 2012to Jul 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

yaron har-shai, Md contact

050-7866206

yaron07@yahoo.com

nir gal or, Md contact

054-5454636

nirgalor@gmail.com

Israel1 site, 1 recruiting
  • Carmel Medical Center

    Haifa, Haifa District

    yaron har-shai, Md, 050-7866206, yaron07@yahoo.com

    nir gal or, Md, 054-5454636, nirgalor@gmail.com

    Recruiting

Other trials in Israel

About this study

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.

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.

Read the detailed description

Skin is the most frequently injured tissue, and millions of people worldwide acquire scars every year. Clinical experience shows that patients want less noticeable scars, with color and texture that closely resemble their normal skin.

Few humans reach adulthood without experiencing a wound to the skin that result in a scar. Scars range from fine lines to raised, hard, red, pruritic and painful hypertrophic or keloid scars, which are severely disfiguring and cause significant morbidity. In addition to physical complications, the appearance of scars can be a major concern for both physicians and their patients. Published literature shows that wide demographic groups, across gender, age, ethnicity and geographical region, have similar concerns about scarring and that patients, in particular, value even small improvements in scarring. It is well established that severe and disfiguring scarring can be associated with significant psychological stress and impairment of quality of life .

It is well documented that following thermal burns injury the development of hypertrophic scars and keloid (HSK) ranges between 40 to 90%.

In the second degree burn the exudate accumulates locally between the epidermis and the dermis of skin, forming blisters. Burn exudate (blister) forms as a result of changed capillary permeability when the damaging agent locally affects the capillaries, as it generally does in inflammatory reactions.

The chemical composition of exudate is very like that of plasma, the protein concentration depending on the degree of damage in capillaries. Further, exudate contains material from damaged and disintegrated cells such as protein degradation products, enzymes etc. By puncturing blisters it should be possible to follow the changes in their content during the healing process.

Only few studies were published in the medical literature in which the blister fluid composition was evaluated following a second degree burn. Nanto and Viljanto at 1962 were the first to publish the chemical composition of blister fluid. They have demonstrated that the albumin-globulin ratio, the phosphorus content and the quantity of purines and pyrimidine derivatives in the blister fluid can be indicators of the local severity of second degree burn.

Heggers et al in 1980 have found that blister fluid, following burn, contained all substances found in the body, including parenterally administered penicillin. In addition the elevation of potassium and the cation to anion imbalance is primarily due to the Na/K cellular pump malfunction, and the destruction of the permeability of the cell membrane is most likely a direct result of complement and other cellular enzymes, which include prostaglandins and thromboxane. Elevated SGOT, CPK, and LDH enzymes indicate severe trauma to the cells. The presence of immunoglobulins indicate that high molecular-weight proteins diffuse equally well during this edematous phase.

In 1986 Deitch et al. studied early protein alteration in the blister fluid and serum associated with burn injury. It was found that local changes in the blister fluid may adversely affect local immunity and predispose the patient to burn wound sepsis.

Lately, a significant improvement in protein identification employing proteomic profiling technology has been documented. The model which is used is the suction blister fluid which is compared with protein expression in pathological skin conditions such as psoriasis and toxic epidermal necrolysis.

However, the evaluation of the blister fluid components on cutaneous scarring has not been investigated.

In 1982, Shepherd and Dawber were the first to apply cryosurgery as a monotherapy regimen for treating Hypertrophic scars and keloids (HSK). Mende, Zouboulis and Orfanos and others showed that repeated surface/spray cryosurgical sessions can have a beneficial effect on HSK (between 68% - 81% remission), with almost no recurrence (2%).

Recently, an intralesional cryosurgery technology has been developed to treat HSK (CryoShape, Etgar Group International Ltd., Kefar Saba, Israel approved by the Israel ministry of Health) (14-21). A specially designed cryoneedle is inserted into the core of the HSK so as to maximize the volume of the HSK to be frozen. The cryoneedle is connected by an adaptor to a cryogun filled with liquid nitrogen, which is introduced into the cryoprobe thereby freezing the HSK. After the HSK is completely frozen, the cryoprobe defrosts and is withdrawn.

Following the cryotreatment a blister is formed. It has been demonstrated that an average of 51 % of scar volume reduction was achieved following a single intralesional cryosurgery treatment. Specifically, for auricular and lobular HSK the average volume reduction was 67% and for upper back and shoulders HSK 60%. These obtained clinical results are significant superior to any other treatment modalities which exist now-days to treat HSK.

Scientific studies which have been executed following the intralesional cryosurgery treatment have demonstrated rejuvenation of the treated scars, i.e., parallelization, and a more organized architecture of the collagen fibers when compared to the pre-treated scars. In addition, histological analysis revealed that after intralesional cryosurgery the collagen bundles lost their swirl structure, the thickness of the collagen layer decreased, and the bundles became more compact with less space between the fibers. A clear distinct transition zone separated the treated from the unaffected area. The frozen tissue was devoid of proliferating cells and of mast cells whereas the number of blood vessels remained unaltered. Most of the fibroblasts expressed all tested myofibroblast markers although some of them exclusively expressed one and not the other. Almost no mast cells were found following the cryo-treatment. Thus, Intralesional cryosurgery treatment resulted in major changes in collagen structure and organization. In addition, the treatment reduced the numbers of proliferated cells in general and myofibroblasts and of mast cells in particular.

It is well documented that cryosurgery wounds generally heal with minimal tissue contraction, resulting in good cosmetic results and with minimal complications.

However, following an extensive medical literature search it has been evident that the evaluation of the blister fluid components following skin cryosurgery for the treatment of HSK has not yet been studied as well as the specific evaluation of post-cryosurgery blister components on cutaneous scarring/anti-scarring effect.

Keywords
scars, blisters, second degree burns, cryosurgery, keloid scars, hypertrophic scars
Medical subject headings
Blister, Wounds and Injuries, Cicatrix, Keloid, Cicatrix, Hypertrophic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01627769
Study groupRoleWhat they receive
second degree blisters patientsblister fluids of second degree burns
cryotherapy blistersblister fluids of cryosurgery wounds

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: at time of sampling.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionJun 2018 (estimated)
  4. Study completionJul 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01627769
Sponsor's protocol ID
CMC-12-0050-CTIL
Status last verified
Feb 2017
First submitted
22 Jun 2012
Last updated
16 Feb 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Blisters and Second Degree Burns, run by Carmel Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact yaron har-shai, Md (050-7866206, yaron07@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2017.

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