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.
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.
Israel1 site, 1 recruiting
- 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
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.
- Conditions
- Blisters, Second Degree Burns, Wounds
- 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 group | Role | What they receive |
|---|---|---|
| second degree blisters patients | blister fluids of second degree burns | |
| cryotherapy blisters | blister fluids of cryosurgery wounds |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted26 Jun 2012 (estimated)
- Study startJul 2012
- Primary completionJun 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BlistersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yaron Har-Shai, Carmel Medical Center
- Investigators
- yaron har-shai, Md, Principal investigator, carmel medical center- ISRAEL
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01627769
- Acronym / sponsor ID
- CMC-12-0050-CTIL
- Conditions
- Blisters, Second Degree Burns, Wounds
- Keywords
- scars, blisters, second degree burns, cryosurgery, keloid scars, hypertrophic scars
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 26 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| second degree blisters patients | – | –blister fluids of second degree burns |
| cryotherapy blisters | – | –blister fluids of cryosurgery wounds |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with second degree burns patients status post cryosurgery treatment for keloid scars with post treatment blisters
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
yaron har-shai, Md principal investigator
carmel medical center- ISRAEL
1 site in 1 country: see every site and its status.
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.