Burn WoundNCT03675568
Non-cultured Autologous Keratinocyte Suspension Versus Traditional Split Skin Graft for Burn Wounds Treatment
A study testing Non-cultured keratinocyte suspension and Split skin Graft in people with Burn Wound, run by Assiut University.
Trial summary
A study comparing effect of non-cultured autologous keratinocyte suspension on burn wounds treatment compared with traditional split skin graft Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Burn Wound
- What is being tested?
- Non-cultured keratinocyte suspension and Split skin Graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2018to 31 Mar 2021
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Deep dermal burns more than 10% total body surface area which require surgical debridement and epidermal replacement.
- Post-burn raw area more than 10% total body surface area
Who cannot join
- Presence of pre-existing local and systemic bacterial infections.
- Pre-existing medical conditions that would interfere with wound healing (uncontrolled diabetes mellitus, malignancy, congestive heart failure, autoimmune disease, renal failure, corticosteroids and immunosuppressive drugs).
About this study
Official title: Non-cultured Autologous Keratinocyte Suspension for Treatment of Deep Dermal Burn and Post-Burn Raw Area Versus Traditional Split Skin Graft
A study comparing effect of non-cultured autologous keratinocyte suspension on burn wounds treatment compared with traditional split skin graft
Read the detailed description
Burn injuries are complicated wounds to manage with a relative high mortality rate in especially large area burns and elderly patients.
Substantial tissue damage and extensive fluid loss can cause impaired vital functions of the skin. When healing is delayed, the potential short term common complications include wound infection affecting the local healing process or systemic inflammatory and immunological responses which subsequently can cause life threatening sepsis and multi-organ failure.
Fortunately, survival rates have improved drastically over the last century due to advancements in burn care such as early surgical intervention, critical care support and wound care.
For many years the "gold standard" for treating wounds of burn patients has been transplantation with an autologous split skin graft. In patients with extensive burn wounds donor sites may be limited. In order to cover all the wounds, the patients often need multiple operations and/or the skin had to be expanded as much as possible.
However, the current different expansion techniques and treatments [mesh and Meek-Wall] frequently lead to scar formation, especially in the large mesh inter-sites.
The rate of wound closure depends on how quickly epidermal cells migrate out of the meshed auto graft and/ or wound edges to close the wound. Accelerating re-epithelialization could potentially improve the outcome of the healing process in terms of reducing granulation tissue formation, reducing the healing time, and thereby reducing the risk of colonization and infection, as well as scar formation.
Since clinical cases were first successfully treated with cultured epithelial layers, keratinocyte sheets have become an important tool in burn wound treatment. However, the clinical application can be limited by long culture time and fragility of the keratinocyte sheets. There is, therefore, a clinical demand for other options to cover large areas of burn wounds in the absence of viable donor sites.
A novel concept consists of treating wounds with epithelial cell suspensions. In 1998, Fraulin et al. developed a method of spreading cell suspension on to wounds using an aerosol spray in a porcine model.
The use of non-cultured keratinocyte suspensions was first reported by Hunyadi et al., showing that a group of patients with burn wounds or chronic leg ulcers, treated with a fibrin matrix containing keratinocytes, healed completely, as opposed to the control group.
In porcine wound models, non-cultured keratinocyte suspensions have been shown to accelerate wound healing, improve quality of epithelialization, and restore melanocyte population, compared to the respective control group.
Major advantages in the use of non-cultured cell suspensions are a drastic reduction of preparation time and possibly easier handling compared to keratinocyte sheets. Particularly, scar quality may be improved by enhancing the speed of epithelialization and fading of mesh patterns in split skin grafts.
In this study, we will compare the results of treating both deep dermal burn wound -following early excision- and post-burn raw area using non-cultured autologous keratinocyte suspension and traditional split skin graft.
- Conditions
- Burn Wound
- Being tested
- Non-cultured keratinocyte suspension, Split skin Graft
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-cultured keratinocyte suspensionProcedure or surgery
A new method for treatment of burn wounds
Split skin GraftProcedure or surgery
A traditional method for treatment of burn wounds
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | Non-Cultured autologous keratinocyte suspension Receives: Procedure: Non-cultured keratinocyte suspension |
| Control group | Active comparator | Split skin Graft Receives: Procedure: Split skin Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean Hospital stay
Number of days patient stays admitted
Measured: 1 month
Secondary outcomes (1)
mean healing time
Number of days until 95% healing
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start1 Nov 2018 (estimated)
- Primary completion30 Sep 2020 (estimated)
- Study completion31 Mar 2021 (estimated)
Why it stopped: Subject changed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Burn WoundStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Diefy Salem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03675568
- Sponsor's protocol ID
- NCAKS
- Status last verified
- Oct 2018
- First submitted
- 17 Sep 2018
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jackson PC, Hardwicke J, Bamford A, Nightingale P, Wilson Y, Papini R, Moiemen N. Revised estimates of mortality from the Birmingham Burn Centre, 2001-2010: a continuing analysis over 65 years. Ann Surg. 2014 May;259(5):979-84. doi: 10.1097/SLA.0b013e31829160ca.
PubMed 23598383Osler T, Glance LG, Hosmer DW. Simplified estimates of the probability of death after burn injuries: extending and updating the baux score. J Trauma. 2010 Mar;68(3):690-7. doi: 10.1097/TA.0b013e3181c453b3.
PubMed 20038856McGwin G Jr, Cross JM, Ford JW, Rue LW 3rd. Long-term trends in mortality according to age among adult burn patients. J Burn Care Rehabil. 2003 Jan-Feb;24(1):21-5. doi: 10.1097/00004630-200301000-00006.
PubMed 12543987Deitch EA, Wheelahan TM, Rose MP, Clothier J, Cotter J. Hypertrophic burn scars: analysis of variables. J Trauma. 1983 Oct;23(10):895-8.
PubMed 6632013Hefton JM, Madden MR, Finkelstein JL, Shires GT. Grafting of burn patients with allografts of cultured epidermal cells. Lancet. 1983 Aug 20;2(8347):428-30. doi: 10.1016/s0140-6736(83)90392-6.
PubMed 6135914Fraulin FO, Bahoric A, Harrop AR, Hiruki T, Clarke HM. Autotransplantation of epithelial cells in the pig via an aerosol vehicle. J Burn Care Rehabil. 1998 Jul-Aug;19(4):337-45. doi: 10.1097/00004630-199807000-00012.
PubMed 9710733Hunyadi J, Farkas B, Bertenyi C, Olah J, Dobozy A. Keratinocyte grafting: a new means of transplantation for full-thickness wounds. J Dermatol Surg Oncol. 1988 Jan;14(1):75-8. doi: 10.1111/j.1524-4725.1988.tb03343.x.
PubMed 2447135
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-cultured Autologous Keratinocyte Suspension for Treatment of Deep Dermal Burn and Post-Burn Raw Area Versus Traditional Split Skin Graft
- ClinicalTrials.gov ID
- NCT03675568
- Acronym / sponsor ID
- NCAKS
- Conditions
- Burn Wound
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Subject changed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (estimated)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 18 Sep 2018 (actual)
- 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.
A study comparing effect of non-cultured autologous keratinocyte suspension on burn wounds treatment compared with traditional split skin graft
Detailed description
Burn injuries are complicated wounds to manage with a relative high mortality rate in especially large area burns and elderly patients.
Substantial tissue damage and extensive fluid loss can cause impaired vital functions of the skin. When healing is delayed, the potential short term common complications include wound infection affecting the local healing process or systemic inflammatory and immunological responses which subsequently can cause life threatening sepsis and multi-organ failure.
Fortunately, survival rates have improved drastically over the last century due to advancements in burn care such as early surgical intervention, critical care support and wound care.
For many years the "gold standard" for treating wounds of burn patients has been transplantation with an autologous split skin graft. In patients with extensive burn wounds donor sites may be limited. In order to cover all the wounds, the patients often need multiple operations and/or the skin had to be expanded as much as possible.
However, the current different expansion techniques and treatments [mesh and Meek-Wall] frequently lead to scar formation, especially in the large mesh inter-sites.
The rate of wound closure depends on how quickly epidermal cells migrate out of the meshed auto graft and/ or wound edges to close the wound. Accelerating re-epithelialization could potentially improve the outcome of the healing process in terms of reducing granulation tissue formation, reducing the healing time, and thereby reducing the risk of colonization and infection, as well as scar formation.
Since clinical cases were first successfully treated with cultured epithelial layers, keratinocyte sheets have become an important tool in burn wound treatment. However, the clinical application can be limited by long culture time and fragility of the keratinocyte sheets. There is, therefore, a clinical demand for other options to cover large areas of burn wounds in the absence of viable donor sites.
A novel concept consists of treating wounds with epithelial cell suspensions. In 1998, Fraulin et al. developed a method of spreading cell suspension on to wounds using an aerosol spray in a porcine model.
The use of non-cultured keratinocyte suspensions was first reported by Hunyadi et al., showing that a group of patients with burn wounds or chronic leg ulcers, treated with a fibrin matrix containing keratinocytes, healed completely, as opposed to the control group.
In porcine wound models, non-cultured keratinocyte suspensions have been shown to accelerate wound healing, improve quality of epithelialization, and restore melanocyte population, compared to the respective control group.
Major advantages in the use of non-cultured cell suspensions are a drastic reduction of preparation time and possibly easier handling compared to keratinocyte sheets. Particularly, scar quality may be improved by enhancing the speed of epithelialization and fading of mesh patterns in split skin grafts.
In this study, we will compare the results of treating both deep dermal burn wound -following early excision- and post-burn raw area using non-cultured autologous keratinocyte suspension and traditional split skin graft.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Procedure: Non-cultured keratinocyte suspensionNon-Cultured autologous keratinocyte suspension |
| Control group | Active comparator | Procedure: Split skin GraftSplit skin Graft |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Deep dermal burns more than 10% total body surface area which require surgical debridement and epidermal replacement.
- Post-burn raw area more than 10% total body surface area
Key exclusion criteria (2 listed)
- Presence of pre-existing local and systemic bacterial infections.
- Pre-existing medical conditions that would interfere with wound healing (uncontrolled diabetes mellitus, malignancy, congestive heart failure, autoimmune disease, renal failure, corticosteroids and immunosuppressive drugs).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-cultured keratinocyte suspensionA new method for treatment of burn wounds | Procedure or surgery | study group |
| Split skin GraftA traditional method for treatment of burn wounds | Procedure or surgery | Control group |
Primary outcome
mean Hospital stay
Time frame: 1 month
Number of days patient stays admitted
1 secondary outcome
mean healing time
Time frame: 1 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
- Background: PubMed 23598383Jackson PC, Hardwicke J, Bamford A, Nightingale P, Wilson Y, Papini R, Moiemen N. Revised estimates of mortality from the Birmingham Burn Centre, 2001-2010: a continuing analysis over 65 years. Ann Surg. 2014 May;259(5):979-84. doi: 10.1097/SLA.0b013e31829160ca.
- Background: PubMed 20038856Osler T, Glance LG, Hosmer DW. Simplified estimates of the probability of death after burn injuries: extending and updating the baux score. J Trauma. 2010 Mar;68(3):690-7. doi: 10.1097/TA.0b013e3181c453b3.
- Background: PubMed 12543987McGwin G Jr, Cross JM, Ford JW, Rue LW 3rd. Long-term trends in mortality according to age among adult burn patients. J Burn Care Rehabil. 2003 Jan-Feb;24(1):21-5. doi: 10.1097/00004630-200301000-00006.
- Background: PubMed 6632013Deitch EA, Wheelahan TM, Rose MP, Clothier J, Cotter J. Hypertrophic burn scars: analysis of variables. J Trauma. 1983 Oct;23(10):895-8.
- Background: PubMed 6135914Hefton JM, Madden MR, Finkelstein JL, Shires GT. Grafting of burn patients with allografts of cultured epidermal cells. Lancet. 1983 Aug 20;2(8347):428-30. doi: 10.1016/s0140-6736(83)90392-6.
- Background: PubMed 9710733Fraulin FO, Bahoric A, Harrop AR, Hiruki T, Clarke HM. Autotransplantation of epithelial cells in the pig via an aerosol vehicle. J Burn Care Rehabil. 1998 Jul-Aug;19(4):337-45. doi: 10.1097/00004630-199807000-00012.
- Background: PubMed 2447135Hunyadi J, Farkas B, Bertenyi C, Olah J, Dobozy A. Keratinocyte grafting: a new means of transplantation for full-thickness wounds. J Dermatol Surg Oncol. 1988 Jan;14(1):75-8. doi: 10.1111/j.1524-4725.1988.tb03343.x.
- Individual participant dataSharing planned: No
Related trials for Burn Wound
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Sepsis, Sepsis-induced Coagulopathy
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
Not yet recruiting
Effect of Short-Video Distraction During Burn Dressing on Anxiety, Pain, and Fear in Children
Burn Injury, Procedural Anxiety
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Peer Bullying Intervention, Vodcast
RecruitingPhase 2
Dupixent in Adults With Refractory Post-Burn Pruritus in an Ambulatory Clinic
Pruritis
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Non-cultured keratinocyte suspension and Split skin Graft in people with Burn Wound, run by Assiut University.
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 2 inclusion and 2 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: withdrawn, as of the sponsor's last update on 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean Hospital stay (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03675568, which also lists 7 linked publications.
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 17 Oct 2018.