Burn InjuryPhase 1/2Bru_PBBNCT05339490
Use of Progenitor Biological Bandages in Burn Care (Bru_PBB)
A Phase 1/2 study testing Progenitor Biological Bandages and Jelonet in people with Burn Injury, run by Dr Anthony De Buys Roessingh at 1 site in Switzerland.
Trial summary
Skin, as the outermost organ of the human body, serves as a protective layer from microorganisms and external forces, and allows controlling fluid loss among other important functions (sensory, immune and aesthetic functions). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Burn Injury
- What is being tested?
- Progenitor Biological Bandages and Jelonet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2025to 17 Jul 2025
- Phase
- Phase 1/2
- 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
- ≤ 2 years old with ≥5% TBSA
- between 3 and 10 years old with ≥10% TBSA
- between 11 and 18 years old with ≥15% TBSA
- ≥ 18 years old with ≥ 20% TBSA
- ≥ 65 years old with ≥ 10% TBSA
- Any age with burns on the face, hands, genitalia or major joints
Show all 11Show fewer
- Patient with 2nd (superficial to deep) degree burn wounds
- Patient with 3rd degree burns candidate for a skin autograft
- Informed Consent as documented by signature and according to consent in case of emergency situation
- First injury
- Possibility of Follow-up for 5 years after injury
Who cannot join
- Infected wounds
- Vitally unstable patients
- Known allergy or hypersensitivity to product of equine origin
- Refusal of the study by the participants or relatives
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Safety and Effectiveness of Progenitor Biological Bandages in Burn Care
Skin, as the outermost organ of the human body, serves as a protective layer from microorganisms and external forces, and allows controlling fluid loss among other important functions (sensory, immune and aesthetic functions). When the skin is burned, the extent of the depth can be classified in 1rst, 2nd superficial to deep, 3rd and 4th degree burns, according to the different layers of the skin and tissue that are affected in depth. Severity of a burn can also be characterized by total body surface area (TBSA), location of the burn injury, subject characteristics and age according to the European Practice Guidelines for Burn Care. The actual gold standard treatment for 3rd or deep 2nd degree burn wounds is skin autografting that means transplantation of healthy skin taken from an undamaged donor site on the patient to the wound site, therefore creating a donor site wound (DSW).
The Burn Center of the CHUV has developed Progenitor Biological Bandages (PBB), composed of human skin progenitor cells (produced and stored GMP clinical cell bank with the Hospital accredited Cell Production Center, CPC) seeded on a biodegradable collagen scaffold (Resorba®), to support wound healing of DSW, as well as 2nd degree burn wounds. PBB have been applied at the CHUV under emergency circumstances over the last 20 years in children and adults with a TBSA higher than 10% and 20%, respectively.
Read more
These PBB aim to increase the spontaneous healing of 2nd superficial and deep burns to avoid the skin autograft, and therefore prevent the creation of a second wound with the DSW. Furthermore, if skin grafting cannot be avoided, in the case of a 3rd or 2nd degree deep burns that do not close spontaneously, the use of PBB is an advantage for treating DSW in order to accelerate its healing process and therefore use the same donor site for future treatments.
The aim of this study is to demonstrate the efficacy of the PBB treatment of the DSW compared to standard-care treatment (Jelonet®), and therefore verify our hypothesis of higher performance of PBB. The investigators would like also to assess the efficacy of the DSW treatment on short- and long-term periods, as well as to collect observational data on 2nd degree burn wound treated with PBB. Furthermore, another objective of this study is to confirm the safety of the PBB on DSW and 2nd degree burn wounds.
Read the detailed description
Study Product / Intervention:
PBB (Progenitor Biological Bandages) produced at CHUV by the Cell Production Center are single-use therapies, which are applied on 2nd degree burns, defined as superficial to partial-thickness burns, and DSW (Donor Site Wound). They can be applied on complex anatomies (moldable) in adults and children of both genders after cleaning of the wounds through showering and debridement. The application of these PBB is prescribed by a specialized surgeon to a patient incapable of spontaneous burn closure and they are only used by health professionals at the CHUV Burn Center. PBB are composed of human skin progenitor cells (FE002- SK2 cell type) originated from a clinical GMP cell bank and seeded on a biodegradable horse collagen scaffold (9x12 cm, Resorba® Medical). PBB are delivered directly to the surgeon in the operating room after a production period of at least 18 hours. The number of PBB ordered by the physician depends on the burned surface area to be treated. They are maintained in the appropriate medium in controlled conditions until delivery and application. They must be applied no later than 72 hours after the start of production. Treatment duration with PBB is 10-12 days post injury for 2nd degree burn wounds and 15 days post DSW creation for DSW.
Control Intervention (if applicable):
To evaluate the performance of treatment with PBB, the investigators plan to compare in a randomization process the efficacy of PBB against a control intervention with Jelonet®. Jelonet® is the standard treatment for treating a DSW when a skin autograft is needed for 2nd and 3rd degree burned patients. The DSW is performed by using a dermatome (Aesculap®, Braun) to retrieve healthy skin (0.2 mm depth) when a skin graft is required to treat burn wound. The DSW is similar to a 2nd degree superficial burn and is able to heal by treatment with Jelonet® dressings (Paraffin Gauze Dressings, 10cm x 10 cm, Smith \& Nephew, UK). The advantage to compare treatments efficacies on a DSW is due to the homogenous properties of a DSW, in comparison to the heterogeneous aspect of a burn wound. Treatment duration of DSW with Jelonet® is 15 days after the creation of DSW.
Measurements and procedures:
Interventional/Comparative cohort (adult and pediatric patients with 2nd or 3rd degree burns treated with a skin autograft):
- Treatment group "Donor site wound": treatment with PBB
- Control group "Donor site wound": treatment with Jelonet® The participants who will be candidates for a skin autograft and a consequent DSW creation with a dermatome will be randomized for the treatment of DSW between PBB and Jelonet® in order to verify the hypothesis of higher performance of PBB in the skin healing process. As soon as the DSW is created, PBB or Jelonet® will be placed on the wound and maintained in place with the help of classical bandages for a maximum of 15 ± 1 days with dressing's changes at Day 5 ± 1 and Day 10 ± 1. In case of the use of PBB, old bandages will be replaced by new ones according to the procedure. When Jelonet® is used, it may occur that the bandage remains adherent to un-epithelialized area. In that case, the edges of the Jelonet® that have peeled off (i.e. where the wound has re-epithelialized) will be cut and new bandages will be applied. Pictures will be taken at each change and on-site evaluation of the wound healing (% of re-epithelialization) will be done by the investigators. If the DSW is not closed at D15 ± 1, Jelonet® will be used to cover the skin until complete skin closure. If the wound is closed after 15 ± 1 days or before, the scar will then be topically treated with cream as standard treatment. All participants will be followed until 5 years according to the long-term evaluation calendar to monitor long-term skin quality.
Interventional/Observational cohort (adult and pediatric patients with 2nd degree burns treated with PBB):
- Treatment group "Burn wound": treatment with PBB For the participants with 2nd degree burns, a first-line treatment of the wounds with PBB as first cover will be prescribed by the surgeon during the first 10- 12 days post injury with maximum 4 dressings' changes every 2-3 days. Old bandages will be replaced by new ones according to the procedure. Pictures will be taken at each bandage change and on-site evaluation of the wound healing will be done by the investigators (% of re-epithelialization). If after 10-12 days, the wound is not closed (95% re-epithelialization not achieved), then the surgeon will decide to perform a skin autograft to help the healing process. If the wound is closed after 10-12 days or before, the scar will then be topically treated with cream. In the case a 2nd degree burn treated with PBB progresses to a 3rd degree burn, the treatment options will be discussed again during treatment and a skin autograft will be performed. All participants will be followed until 5 years post injury according to the long-term evaluation calendar to monitor long-term skin quality.
- Conditions
- Burn Injury
- Being tested
- Progenitor Biological Bandages, Jelonet
- Keywords
- cell therapies, fetal progenitor cells, regenerative medicine, standardized transplants, wound healing
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progenitor Biological BandagesDrug
Also called PBB
The patients candidates for a skin autograft and a consequent Donor Site Wound (DSW) creation with a dermatome will be randomized between 2 treatment arms. As soon as DSW is created and according to randomization results, PBB will be placed on the wound and maintained in place with the help of classical bandages for a maximum of 15 ± 1 days with dressing's changes at Day 5 ± 1 and Day 10 ± 1. Old PBB will be replaced by new ones according to the local procedure.
Pictures will be taken at each change and on-site evaluation of the wound healing (% of re-epithelialization) will be done by the surgeon. If the DSW is not closed at D15 ± 1, Jelonet® will be used to cover the skin until complete skin closure. If the wound is closed after 15 ± 1 days or before, the scar will then be topically treated with cream as standard treatment. All patients will be followed until 5 years according to the long-term evaluation calendar to monitor long-term skin quality.
JelonetDevice
The patients candidates for a skin autograft and a consequent Donor Site Wound (DSW) creation with a dermatome will be randomized between 2 treatment arms. As soon as DSW is created and according to randomization results, Jelonet, as standard bandages, will be placed on the wound and maintained in place with the help of classical bandages for a maximum of 15 ± 1 days with dressing's changes at Day 5 ± 1 and Day 10 ± 1.
Pictures will be taken at each change and on-site evaluation of the wound healing (% of re-epithelialization) will be done by the surgeon. If the DSW is not closed at D15 ± 1, Jelonet® will be used to cover the skin until complete skin closure. If the wound is closed after 15 ± 1 days or before, the scar will then be topically treated with cream as standard treatment. All patients will be followed until 5 years according to the long-term evaluation calendar to monitor long-term skin quality.
| Study group | Role | What they receive |
|---|---|---|
| Progenitor Biological Bandages | Experimental | Donor Site Wound (DSW) is created with a dermatome. PBB are placed on the wound and maintained in place with the help of classical bandages for a maximum of 15 ± 1 days.
Dressing's changes are performed at Day 5 ± 1 and Day 10 ± 1. Receives: Drug: Progenitor Biological Bandages |
| Jelonet | Active comparator | Donor Site Wound is created with a dermatome. Jelonet® are placed on the wound and maintained in place with the help of classical bandages for a maximum of 15 ± 1 days.
Dressing's changes are performed at Day 5 ± 1 and Day 10 ± 1. Receives: Device: Jelonet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound re-epithelialization assessment at Day 10
95 percent skin re-epithelialization (yes or no) will be assessed 10 days after the start of treatment and creation of the DSW
Measured: Day 10 of treatment
Secondary outcomes (4)
Short-term efficacy of treatment
Percentage of re-epithelialization (percent) by measuring the length (cm) and height (cm) of the wound at each evaluation time point compared to Day 1 of treatment
Measured: Day 5, Day 10, and Day 15 of treatment
Long-term skin quality - Scar appearance (Vancouver Scar Scale)
The Vancouver scale allows to measure scar appearance by evaluation of scores for:
- skin pliability (0=Normal; 1=Supple; 2=Yielding; 3=Firm; 4=Adherent),
- skin vascularization (0=Normal; 1=Pink; 2=Red; 3=Purple)
- skin pigmentation (0=Normal; 1=Hypopigmentation; 2=Mixed; 3=Hyperpigmentation). The quality of the skin is assessed both by vision and touch by medical experts for a better standardization. Higher scores mean a worse outcome.
Measured: From 1 month to 5 years post skin closure
Long-term skin quality - Scar colour
Scar colour will be evaluated with a probe-based skin analysis system from Cortex Technology. The erythema and melanin indexes (EI and MI) are read directly on the device with arbitrary units specific to the device (between 0 and 100).
Measured: From 1 month to 5 years post skin closure
Long-term skin quality - Elastography
Elastic properties of the repaired skin (m/s) using a probe-based skin analysis system from Cortex Technology will be measured and compared to healthy skin.
Measured: From 1 month to 5 years post skin closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start1 Jul 2025
- Primary completion17 Jul 2025
- Study completion17 Jul 2025
Why it stopped: Following issues with the quality of the clinical cell banks used to manufacture the biological dressings, we decided not to implement this research to not compromise neither the patient safety, nor the expected efficacy of the treatment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Burn InjuryStudies 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Anthony De Buys Roessingh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Anthony De Buys Roessingh, Centre Hospitalier Universitaire Vaudois
- Investigators
- Anthony De Buys Roessingh, Principal investigator, Lausanne Burn Center, Lausanne University Hospital CHUV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05339490
- Sponsor's protocol ID
- RA10106
- Other IDs
- 2020-01873, 2020TpP1010
- Acronym
- Bru_PBB
- Status last verified
- Jul 2025
- First submitted
- 4 Apr 2022
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hohlfeld J, de Buys Roessingh A, Hirt-Burri N, Chaubert P, Gerber S, Scaletta C, Hohlfeld P, Applegate LA. Tissue engineered fetal skin constructs for paediatric burns. Lancet. 2005 Sep 3-9;366(9488):840-2. doi: 10.1016/S0140-6736(05)67107-3.
PubMed 16139659De Buys Roessingh AS, Hohlfeld J, Scaletta C, Hirt-Burri N, Gerber S, Hohlfeld P, Gebbers JO, Applegate LA. Development, characterization, and use of a fetal skin cell bank for tissue engineering in wound healing. Cell Transplant. 2006;15(8-9):823-34. doi: 10.3727/000000006783981459.
PubMed 17269452Abdel-Sayed P, Michetti M, Scaletta C, Flahaut M, Hirt-Burri N, de Buys Roessingh A, Raffoul W, Applegate LA. Cell therapies for skin regeneration: an overview of 40 years of experience in burn units. Swiss Med Wkly. 2019 May 19;149:w20079. doi: 10.4414/smw.2019.20079. eCollection 2019 May 6.
PubMed 31104308Abdel-Sayed P, Hirt-Burri N, de Buys Roessingh A, Raffoul W, Applegate LA. Evolution of Biological Bandages as First Cover for Burn Patients. Adv Wound Care (New Rochelle). 2019 Nov 1;8(11):555-564. doi: 10.1089/wound.2019.1037. Epub 2019 Oct 16.
PubMed 31637102Laurent A, Lin P, Scaletta C, Hirt-Burri N, Michetti M, de Buys Roessingh AS, Raffoul W, She BR, Applegate LA. Bringing Safe and Standardized Cell Therapies to Industrialized Processing for Burns and Wounds. Front Bioeng Biotechnol. 2020 Jun 19;8:581. doi: 10.3389/fbioe.2020.00581. eCollection 2020.
PubMed 32637400
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Effectiveness of Progenitor Biological Bandages in Burn Care
- ClinicalTrials.gov ID
- NCT05339490
- Acronym / sponsor ID
- Bru_PBB / RA10106
- Conditions
- Burn Injury
- Keywords
- cell therapies, fetal progenitor cells, regenerative medicine, standardized transplants, wound healing
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Following issues with the quality of the clinical cell banks used to manufacture the biological dressings, we decided not to implement this research to not compromise neither the patient safety, nor the expected efficacy of the treatment.
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Dr Anthony De Buys RoessinghUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 17 Jul 2025 (actual)
- Study completion
- 17 Jul 2025 (actual)
- First posted
- 21 Apr 2022 (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.
Skin, as the outermost organ of the human body, serves as a protective layer from microorganisms and external forces, and allows controlling fluid loss among other important functions (sensory, immune and aesthetic functions). When the skin is burned, the extent of the depth can be classified in 1rst, 2nd superficial to deep, 3rd and 4th degree burns, according to the different layers of the skin and tissue that are affected in depth. Severity of a burn can also be characterized by total body surface area (TBSA), location of the burn injury, subject characteristics and age according to the European Practice Guidelines for Burn Care. The actual gold standard treatment for 3rd or deep 2nd degree burn wounds is skin autografting that means transplantation of healthy skin taken from an undamaged donor site on the patient to the wound site, therefore creating a donor site wound (DSW).
The Burn Center of the CHUV has developed Progenitor Biological Bandages (PBB), composed of human skin progenitor cells (produced and stored GMP clinical cell bank with the Hospital accredited Cell Production Center, CPC) seeded on a biodegradable collagen scaffold (Resorba®), to support wound healing of DSW, as well as 2nd degree burn wounds. PBB have been applied at the CHUV under emergency circumstances over the last 20 years in children and adults with a TBSA higher than 10% and 20%, respectively.
These PBB aim to increase the spontaneous healing of 2nd superficial and deep burns to avoid the skin autograft, and therefore prevent the creation of a second wound with the DSW. Furthermore, if skin grafting cannot be avoided, in the case of a 3rd or 2nd degree deep burns that do not close spontaneously, the use of PBB is an advantage for treating DSW in order to accelerate its healing process and therefore use the same donor site for future treatments.
The aim of this study is to demonstrate the efficacy of the PBB treatment of the DSW compared to standard-care treatment (Jelonet®), and therefore verify our hypothesis of higher performance of PBB. The investigators would like also to assess the efficacy of the DSW treatment on short- and long-term periods, as well as to collect observational data on 2nd degree burn wound treated with PBB. Furthermore, another objective of this study is to confirm the safety of the PBB on DSW and 2nd degree burn wounds.
Detailed description
Study Product / Intervention:
PBB (Progenitor Biological Bandages) produced at CHUV by the Cell Production Center are single-use therapies, which are applied on 2nd degree burns, defined as superficial to partial-thickness burns, and DSW (Donor Site Wound). They can be applied on complex anatomies (moldable) in adults and children of both genders after cleaning of the wounds through showering and debridement. The application of these PBB is prescribed by a specialized surgeon to a patient incapable of spontaneous burn closure and they are only used by health professionals at the CHUV Burn Center. PBB are composed of human skin progenitor cells (FE002- SK2 cell type) originated from a clinical GMP cell bank and seeded on a biodegradable horse collagen scaffold (9x12 cm, Resorba® Medical). PBB are delivered directly to the surgeon in the operating room after a production period of at least 18 hours. The number of PBB ordered by the physician depends on the burned surface area to be treated. They are maintained in the appropriate medium in controlled conditions until delivery and application. They must be applied no later than 72 hours after the start of production. Treatment duration with PBB is 10-12 days post injury for 2nd degree burn wounds and 15 days post DSW creation for DSW.
Control Intervention (if applicable):
To evaluate the performance of treatment with PBB, the investigators plan to compare in a randomization process the efficacy of PBB against a control intervention with Jelonet®. Jelonet® is the standard treatment for treating a DSW when a skin autograft is needed for 2nd and 3rd degree burned patients. The DSW is performed by using a dermatome (Aesculap®, Braun) to retrieve healthy skin (0.2 mm depth) when a skin graft is required to treat burn wound. The DSW is similar to a 2nd degree superficial burn and is able to heal by treatment with Jelonet® dressings (Paraffin Gauze Dressings, 10cm x 10 cm, Smith \& Nephew, UK). The advantage to compare treatments efficacies on a DSW is due to the homogenous properties of a DSW, in comparison to the heterogeneous aspect of a burn wound. Treatment duration of DSW with Jelonet® is 15 days after the creation of DSW.
Measurements and procedures:
Interventional/Comparative cohort (adult and pediatric patients with 2nd or 3rd degree burns treated with a skin autograft):
- Treatment group "Donor site wound": treatment with PBB
- Control group "Donor site wound": treatment with Jelonet® The participants who will be candidates for a skin autograft and a consequent DSW creation with a dermatome will be randomized for the treatment of DSW between PBB and Jelonet® in order to verify the hypothesis of higher performance of PBB in the skin healing process. As soon as the DSW is created, PBB or Jelonet® will be placed on the wound and maintained in place with the help of classical bandages for a maximum of 15 ± 1 days with dressing's changes at Day 5 ± 1 and Day 10 ± 1. In case of the use of PBB, old bandages will be replaced by new ones according to the procedure. When Jelonet® is used, it may occur that the bandage remains adherent to un-epithelialized area. In that case, the edges of the Jelonet® that have peeled off (i.e. where the wound has re-epithelialized) will be cut and new bandages will be applied. Pictures will be taken at each change and on-site evaluation of the wound healing (% of re-epithelialization) will be done by the investigators. If the DSW is not closed at D15 ± 1, Jelonet® will be used to cover the skin until complete skin closure. If the wound is closed after 15 ± 1 days or before, the scar will then be topically treated with cream as standard treatment. All participants will be followed until 5 years according to the long-term evaluation calendar to monitor long-term skin quality.
Interventional/Observational cohort (adult and pediatric patients with 2nd degree burns treated with PBB):
- Treatment group "Burn wound": treatment with PBB For the participants with 2nd degree burns, a first-line treatment of the wounds with PBB as first cover will be prescribed by the surgeon during the first 10- 12 days post injury with maximum 4 dressings' changes every 2-3 days. Old bandages will be replaced by new ones according to the procedure. Pictures will be taken at each bandage change and on-site evaluation of the wound healing will be done by the investigators (% of re-epithelialization). If after 10-12 days, the wound is not closed (95% re-epithelialization not achieved), then the surgeon will decide to perform a skin autograft to help the healing process. If the wound is closed after 10-12 days or before, the scar will then be topically treated with cream. In the case a 2nd degree burn treated with PBB progresses to a 3rd degree burn, the treatment options will be discussed again during treatment and a skin autograft will be performed. All participants will be followed until 5 years post injury according to the long-term evaluation calendar to monitor long-term skin quality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progenitor Biological Bandages | Experimental | Drug: Progenitor Biological BandagesDonor Site Wound (DSW) is created with a dermatome. PBB are placed on the wound and maintained in place with the help of classical bandages for a maximum of 15 ± 1 days. Dressing's changes are performed at Day 5 ± 1 and Day 10 ± 1. |
| Jelonet | Active comparator | Device: JelonetDonor Site Wound is created with a dermatome. Jelonet® are placed on the wound and maintained in place with the help of classical bandages for a maximum of 15 ± 1 days. Dressing's changes are performed at Day 5 ± 1 and Day 10 ± 1. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- ≤ 2 years old with ≥5% TBSA
- between 3 and 10 years old with ≥10% TBSA
- between 11 and 18 years old with ≥15% TBSA
- ≥ 18 years old with ≥ 20% TBSA
- ≥ 65 years old with ≥ 10% TBSA
Key exclusion criteria (4 listed)
- Infected wounds
- Vitally unstable patients
- Known allergy or hypersensitivity to product of equine origin
- Refusal of the study by the participants or relatives
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 |
|---|---|---|
| Progenitor Biological BandagesAlso: PBBThe patients candidates for a skin autograft and a consequent Donor Site Wound (DSW) creation with a dermatome will be randomized between 2 treatment arms. As soon as DSW is created and according to randomization results, PBB will be placed on the wound and maintained in place with the help of classical bandages for a maximum of 15 ± 1 days with dressing's changes at Day 5 ± 1 and Day 10 ± 1. Old PBB will be replaced by new ones according to the local procedure. Pictures will be taken at each change and on-site evaluation of the wound healing (% of re-epithelialization) will be done by the surgeon. If the DSW is not closed at D15 ± 1, Jelonet® will be used to cover the skin until complete skin closure. If the wound is closed after 15 ± 1 days or before, the scar will then be topically treated with cream as standard treatment. All patients will be followed until 5 years according to the long-term evaluation calendar to monitor long-term skin quality. | Drug | Progenitor Biological Bandages |
| JelonetThe patients candidates for a skin autograft and a consequent Donor Site Wound (DSW) creation with a dermatome will be randomized between 2 treatment arms. As soon as DSW is created and according to randomization results, Jelonet, as standard bandages, will be placed on the wound and maintained in place with the help of classical bandages for a maximum of 15 ± 1 days with dressing's changes at Day 5 ± 1 and Day 10 ± 1. Pictures will be taken at each change and on-site evaluation of the wound healing (% of re-epithelialization) will be done by the surgeon. If the DSW is not closed at D15 ± 1, Jelonet® will be used to cover the skin until complete skin closure. If the wound is closed after 15 ± 1 days or before, the scar will then be topically treated with cream as standard treatment. All patients will be followed until 5 years according to the long-term evaluation calendar to monitor long-term skin quality. | Device | Jelonet |
Primary outcome
Wound re-epithelialization assessment at Day 10
Time frame: Day 10 of treatment
95 percent skin re-epithelialization (yes or no) will be assessed 10 days after the start of treatment and creation of the DSW
4 secondary outcomes
Short-term efficacy of treatment
Time frame: Day 5, Day 10, and Day 15 of treatment
Long-term skin quality - Scar appearance (Vancouver Scar Scale)
Time frame: From 1 month to 5 years post skin closure
Long-term skin quality - Scar colour
Time frame: From 1 month to 5 years post skin closure
Long-term skin quality - Elastography
Time frame: From 1 month to 5 years post skin closure
Results and safety
The study was stopped early (reason given: Following issues with the quality of the clinical cell banks used to manufacture the biological dressings, we decided not to implement this research to not compromise neither the patient safety, nor the expected efficacy of the treatment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Background: PubMed 16139659Hohlfeld J, de Buys Roessingh A, Hirt-Burri N, Chaubert P, Gerber S, Scaletta C, Hohlfeld P, Applegate LA. Tissue engineered fetal skin constructs for paediatric burns. Lancet. 2005 Sep 3-9;366(9488):840-2. doi: 10.1016/S0140-6736(05)67107-3.
- Background: PubMed 17269452De Buys Roessingh AS, Hohlfeld J, Scaletta C, Hirt-Burri N, Gerber S, Hohlfeld P, Gebbers JO, Applegate LA. Development, characterization, and use of a fetal skin cell bank for tissue engineering in wound healing. Cell Transplant. 2006;15(8-9):823-34. doi: 10.3727/000000006783981459.
- Background: PubMed 31104308Abdel-Sayed P, Michetti M, Scaletta C, Flahaut M, Hirt-Burri N, de Buys Roessingh A, Raffoul W, Applegate LA. Cell therapies for skin regeneration: an overview of 40 years of experience in burn units. Swiss Med Wkly. 2019 May 19;149:w20079. doi: 10.4414/smw.2019.20079. eCollection 2019 May 6.
- Background: PubMed 31637102Abdel-Sayed P, Hirt-Burri N, de Buys Roessingh A, Raffoul W, Applegate LA. Evolution of Biological Bandages as First Cover for Burn Patients. Adv Wound Care (New Rochelle). 2019 Nov 1;8(11):555-564. doi: 10.1089/wound.2019.1037. Epub 2019 Oct 16.
- Background: PubMed 32637400Laurent A, Lin P, Scaletta C, Hirt-Burri N, Michetti M, de Buys Roessingh AS, Raffoul W, She BR, Applegate LA. Bringing Safe and Standardized Cell Therapies to Industrialized Processing for Burns and Wounds. Front Bioeng Biotechnol. 2020 Jun 19;8:581. doi: 10.3389/fbioe.2020.00581. eCollection 2020.
- Individual participant dataSharing planned: No
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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.
Anthony De Buys Roessingh principal investigator
Lausanne Burn Center, Lausanne University Hospital CHUV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Progenitor Biological Bandages and Jelonet in people with Burn Injury, run by Dr Anthony De Buys Roessingh at 1 site in Switzerland.
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 11 inclusion and 4 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: stopped early, as of the sponsor's last update on 22 Jul 2025. 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 Switzerland. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Following issues with the quality of the clinical cell banks used to manufacture the biological dressings, we decided not to implement this research to not compromise neither the patient safety, nor the expected efficacy of the treatment.). Results are not available in the source record.
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?
Wound re-epithelialization assessment at Day 10 (time frame: Day 10 of treatment). 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 NCT05339490, which also lists 5 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 22 Jul 2025.