Split Thickness Skin GraftPhase 1/2CICAFASTNCT03334656
Controlled Comparison of a Traditional Dressing Versus a Biologic Dressing Composed of Fetal Fibroblasts and Keratinocytes in Association With a Collagen Matrix on Skin Donor Sites
A Phase 1/2 study testing biological dressing and Paraffin gauze dressing in people with Split Thickness Skin Graft and Wound Healing, run by Nantes University Hospital at 2 sites in France.
Trial summary
Cell-based engineered skin substitutes are promising to treat difficult-to-heal acute and chronic wounds such as large/deep burns, ulcers resistant to conventional therapies or surgical wounds. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Split Thickness Skin Graft, Wound Healing
- What is being tested?
- biological dressing and Paraffin gauze dressing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesFrance
- Study dates
- 16 May 2018to 15 Jul 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or male aged ≥18 years old
- For potentially childbearing female, only those with effective contraception (contraception pill, implant and intrauterine device) could be included
- Patient who need skin graft ( height equal to or greater than 100cm2 and thickness 1.2mm) after surgery excision
- Patients with social security
- Patients able to understand and follow the trial instructions
- Patients who have signed an informed consent
Who cannot join
- Patients with an history of cancers except basal and squamous cell, cutaneous carcinoma.
- Patients suffering from uncontrolled metabolic disease (for instance diabete), from a psychiatric disorder not treated, with severe arteritis of lower and/or upper limbs, treated with anticoagulant (unless treatment stops 7 days before the surgery), with severe venous insufficiency, suffering of severe polyneuropathy, with known allergy to antibiotics,
- Patients with an allergic predisposition or known allergy to bovine collagen or silicone
- Patients receiving corticosteroids, immunosuppressive or cytotoxic agents unless treatment stops 4 weeks before the surgery
- Patients contraindicated with local anesthetic used in STSG process of his investigator center
- Patients with systemic infection (all grade defined by CTCAE Common Terminology Criteria for Adverse Event V4.03) at surgery visit will not be included in this trial because of the contraindication of the surgical gesture.
Show all 13Show fewer
- Patient intolerant to the conventional treatment (JELONET®)
- Patient intolerant to URGO TUL®
- Patient intolerant to TELFA®
- Patient intolerant to the stretchable strip (HYPAFIX® or NYLEX®)
- Pregnant or breast-feeding women
- Patients participating in clinical trial
- Vulnerable people: persons deprived of liberty; under trusteeship or under curatorship
Trial locations and contacts
2 sites in 1 country.
About this study
Cell-based engineered skin substitutes are promising to treat difficult-to-heal acute and chronic wounds such as large/deep burns, ulcers resistant to conventional therapies or surgical wounds. Cultured autologous epidermal cell-based therapy is used for more than two decades as permanent wound coverage for large burns. Although this technique has been shown to improve outcomes in patients with large burn injuries, its clinical use is limited by the creation of a second wound at the donor site, the three-week delay needed to obtain sufficient amounts of cells, and the absence of a dermal component resulting in low graft take and wound contraction.
Concurrently, allogeneic cell-based engineered skin substitutes have been proposed. Where they offer off-the-shelf temporary wound coverage acting as biologically active dressings releasing growth factors, cytokines and extra cellular matrix components essential for proper wound healing, they are susceptible of immune rejection that is their major weakness Fetal skin, before the third trimester of gestational age, heals rapidly without scar formation conversely to adult skin. Minimal inflammation, specific cytokine and growth factor profiles, and faster and organized deposit and turnover of Extra Cellular Matrix (ECM) components during fetal wound healing have been proposed to explain the absence of scar formation. Because of their low immunogenicity, and their unique regeneration properties, fetal skin cells represent an attractive alternative to the commonly used autologous and allogenic cutaneous grafts.
Read more
The investigators developed a new healing dressing constituted by a collagen sponge seeded with a specific ratio of active fetal fibroblasts and keratinocytes producing a variety of wound healing growth factors and cytokines which increase the speed of wound healing, induce an immunotolerant state, with a low inflammatory reaction.
This prospective randomized controlled study aims to compare wound healing of CICAFAST versus conventional treatment (JELONET®) in the treatment of split-thickness skin graft donor site at D8. The patient will be his own control.
- Conditions
- Split Thickness Skin Graft, Wound Healing
- Being tested
- biological dressing, Paraffin gauze dressing
- Keywords
- Split thickness skin graft donor site, wound healing, Fetal skin bioconstruct, Fibroblasts, Keratinocytes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biological dressingBiological
to test a biological dressing on the wound healing of the split-thickness skin graft donor site
Paraffin gauze dressingOther
standard intervention : Paraffin gauze dressing on the wound healing
| Study group | Role | What they receive |
|---|---|---|
| Biological Dressing | Experimental | It is a cellularized dressing of 100 cm² composed of fetal skin cells associated to a bovine collagen matrix:
* Fetal skin cells were obtained from a single fetal skin sample and consist in two clinical grade banks of keratinocytes (reference BKF07 K CB1) and fibroblasts (reference BKF07 WCB F d P3) produced at the UTCG. These two clinical grade cells banks were fully characterized and secure.
* The matrix is a customized type I calf collagen produced by the company Symatese. Symatese's collagen is in compliance with the European requirements Receives: Biological: biological dressing |
| Paraffin Gauze Dressing | Active comparator | It is a low-adherent, sterile paraffin Tulle Gras dressing made from open weave gauze. The gauze has interlocking threads which minimize fraying when the dressing is cut to shape. JELONET® dressings are non-medicated and are used as a primary wound contact layer with paraffin present to reduce the adherence of the product to the surface of a granulating wound.
JELONET® is a product of Smith-Nephew, it has the CE-mark (n°0086) and the class of this medical device is IIa.
The features of this dressing are: Soft paraffin base, Sterile leno weave presentation, Comprehensive size range. Receives: Other: Paraffin gauze dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound healing
The number of complete healing at D8 judged by physician observer. Healing is defined as 80% or more wound closure.
Measured: Day 8
Secondary outcomes (6)
concordance between the healing at D8 (or D11 and D15) judged by physician observer and by another physician using photographs
The healing at D8 (or D11 or D15 if the healing is not completed) judged by an expert physician on picture. Healing is defined as 80% or more wound closure.
Measured: Day 8 (or D11 and D15 if the healing is not completed)
wound healing's rapidity of CICAFAST versus conventional treatment (JELONET®) in the treatment of STSG donor site.
Time to healing (in days) judged by physician observer
Measured: D8 And D11 (if the healing is not completed) and D15 (if the healing is not completed)
tolerance of CICAFAST versus the conventional treatment (JELONET®)
- AE notification: case of infection: patients with grade 1 or 2 infections may be controlled by antibiotherapy. Patients with grade 3 or 4 infection or with biological dressing (CICAFAST) rejection will have CICAFAST dressing removed. However they will stay in the study. Immunological monitoring will be performed to follow a CICAFAST reject of the patient at donor site level.
Measured: 6 months
pain of the wound healing with CICAFAST versus conventional treatment (JELONET®)
Number of painful day/wound from the surgery until the complete healing
Measured: Day 8 And D11 (if the healing is not completed) and D15 (if the healing is not completed)
quality of the wound healing with CICAFAST versus conventional treatment (JELONET®)
Evaluation of the quality of the wound healing by an observer (physician who will not do the patient surgery) at M3 and M6, OSAS (observer scar assessment scale ; 1= normal skin, 10= worst imaginable scar) will be used. By the patient PSAS (patient scar assessment scale ; 1= normal skin, 10= very different) will be used and expertise on picture by 2 external experts (Visual Analogue Scale 10 the worst scar to 1 like normal skin). A second evaluation of complete healing will be performed by two exterior independent experts evaluating the photographs taken until complete healing (Healing is defined as 80% or more wound closure)
Measured: 6 months
quality of the wound healing with CICAFAST versus conventional treatment (JELONET®) for the patient who will have confocal microscopy
Results of scars confocal microscopy at M3
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start16 May 2018
- Primary completion15 Jul 2024
- Study completion15 Jul 2024
Why it stopped: It was decided to terminate the study prematurely due to insufficient enrolment, despite extensions to the enrolment period.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Split Thickness Skin GraftStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brigitte Dréno, Pr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03334656
- Sponsor's protocol ID
- RC16_0019
- Acronym
- CICAFAST
- Status last verified
- Aug 2024
- First submitted
- 30 Oct 2017
- Last updated
- 12 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Poinas A, Perrot P, Lorant J, Nerriere O, Nguyen JM, Saiagh S, Frenard C, Leduc A, Malard O, Espitalier F, Duteille F, Chiffoleau A, Vrignaud F, Khammari A, Dreno B. CICAFAST: comparison of a biological dressing composed of fetal fibroblasts and keratinocytes on a split-thickness skin graft donor site versus a traditional dressing: a randomized controlled trial. Trials. 2019 Oct 28;20(1):612. doi: 10.1186/s13063-019-3718-4.
PubMed 31661012
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Comparison of a Traditional Dressing Versus a Biologic Dressing Composed of Fetal Fibroblasts and Keratinocytes in Association With a Collagen Matrix on Skin Donor Sites
- ClinicalTrials.gov ID
- NCT03334656
- Acronym / sponsor ID
- CICAFAST / RC16_0019
- Conditions
- Split Thickness Skin Graft, Wound Healing
- Keywords
- Split thickness skin graft donor site, wound healing, Fetal skin bioconstruct, Fibroblasts, Keratinocytes
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: It was decided to terminate the study prematurely due to insufficient enrolment, despite extensions to the enrolment period.
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 16 May 2018 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 7 Nov 2017 (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.
Cell-based engineered skin substitutes are promising to treat difficult-to-heal acute and chronic wounds such as large/deep burns, ulcers resistant to conventional therapies or surgical wounds. Cultured autologous epidermal cell-based therapy is used for more than two decades as permanent wound coverage for large burns. Although this technique has been shown to improve outcomes in patients with large burn injuries, its clinical use is limited by the creation of a second wound at the donor site, the three-week delay needed to obtain sufficient amounts of cells, and the absence of a dermal component resulting in low graft take and wound contraction.
Concurrently, allogeneic cell-based engineered skin substitutes have been proposed. Where they offer off-the-shelf temporary wound coverage acting as biologically active dressings releasing growth factors, cytokines and extra cellular matrix components essential for proper wound healing, they are susceptible of immune rejection that is their major weakness Fetal skin, before the third trimester of gestational age, heals rapidly without scar formation conversely to adult skin. Minimal inflammation, specific cytokine and growth factor profiles, and faster and organized deposit and turnover of Extra Cellular Matrix (ECM) components during fetal wound healing have been proposed to explain the absence of scar formation. Because of their low immunogenicity, and their unique regeneration properties, fetal skin cells represent an attractive alternative to the commonly used autologous and allogenic cutaneous grafts.
The investigators developed a new healing dressing constituted by a collagen sponge seeded with a specific ratio of active fetal fibroblasts and keratinocytes producing a variety of wound healing growth factors and cytokines which increase the speed of wound healing, induce an immunotolerant state, with a low inflammatory reaction.
This prospective randomized controlled study aims to compare wound healing of CICAFAST versus conventional treatment (JELONET®) in the treatment of split-thickness skin graft donor site at D8. The patient will be his own control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biological Dressing | Experimental | Biological: biological dressingIt is a cellularized dressing of 100 cm² composed of fetal skin cells associated to a bovine collagen matrix: * Fetal skin cells were obtained from a single fetal skin sample and consist in two clinical grade banks of keratinocytes (reference BKF07 K CB1) and fibroblasts (reference BKF07 WCB F d P3) produced at the UTCG. These two clinical grade cells banks were fully characterized and secure. * The matrix is a customized type I calf collagen produced by the company Symatese. Symatese's collagen is in compliance with the European requirements |
| Paraffin Gauze Dressing | Active comparator | Other: Paraffin gauze dressingIt is a low-adherent, sterile paraffin Tulle Gras dressing made from open weave gauze. The gauze has interlocking threads which minimize fraying when the dressing is cut to shape. JELONET® dressings are non-medicated and are used as a primary wound contact layer with paraffin present to reduce the adherence of the product to the surface of a granulating wound. JELONET® is a product of Smith-Nephew, it has the CE-mark (n°0086) and the class of this medical device is IIa. The features of this dressing are: Soft paraffin base, Sterile leno weave presentation, Comprehensive size range. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female or male aged ≥18 years old
- For potentially childbearing female, only those with effective contraception (contraception pill, implant and intrauterine device) could be included
- Patient who need skin graft ( height equal to or greater than 100cm2 and thickness 1.2mm) after surgery excision
- Patients with social security
- Patients able to understand and follow the trial instructions
Key exclusion criteria (13 listed)
- Patients with an history of cancers except basal and squamous cell, cutaneous carcinoma.
- Patients suffering from uncontrolled metabolic disease (for instance diabete), from a psychiatric disorder not treated, with severe arteritis of lower and/or upper limbs, treated with anticoagulant (unless treatment stops 7 days before the surgery), with severe venous insufficiency, suffering of severe polyneuropathy, with known allergy to antibiotics,
- Patients with an allergic predisposition or known allergy to bovine collagen or silicone
- Patients receiving corticosteroids, immunosuppressive or cytotoxic agents unless treatment stops 4 weeks before the surgery
- Patients contraindicated with local anesthetic used in STSG process of his investigator center
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 |
|---|---|---|
| biological dressingto test a biological dressing on the wound healing of the split-thickness skin graft donor site | Biological | Biological Dressing |
| Paraffin gauze dressingstandard intervention : Paraffin gauze dressing on the wound healing | Other | Paraffin Gauze Dressing |
Primary outcome
wound healing
Time frame: Day 8
The number of complete healing at D8 judged by physician observer. Healing is defined as 80% or more wound closure.
6 secondary outcomes
concordance between the healing at D8 (or D11 and D15) judged by physician observer and by another physician using photographs
Time frame: Day 8 (or D11 and D15 if the healing is not completed)
wound healing's rapidity of CICAFAST versus conventional treatment (JELONET®) in the treatment of STSG donor site.
Time frame: D8 And D11 (if the healing is not completed) and D15 (if the healing is not completed)
tolerance of CICAFAST versus the conventional treatment (JELONET®)
Time frame: 6 months
pain of the wound healing with CICAFAST versus conventional treatment (JELONET®)
Time frame: Day 8 And D11 (if the healing is not completed) and D15 (if the healing is not completed)
quality of the wound healing with CICAFAST versus conventional treatment (JELONET®)
Time frame: 6 months
quality of the wound healing with CICAFAST versus conventional treatment (JELONET®) for the patient who will have confocal microscopy
Time frame: 3 months
Results and safety
The study was stopped early (reason given: It was decided to terminate the study prematurely due to insufficient enrolment, despite extensions to the enrolment period.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Derived from this study: PubMed 31661012Poinas A, Perrot P, Lorant J, Nerriere O, Nguyen JM, Saiagh S, Frenard C, Leduc A, Malard O, Espitalier F, Duteille F, Chiffoleau A, Vrignaud F, Khammari A, Dreno B. CICAFAST: comparison of a biological dressing composed of fetal fibroblasts and keratinocytes on a split-thickness skin graft donor site versus a traditional dressing: a randomized controlled trial. Trials. 2019 Oct 28;20(1):612. doi: 10.1186/s13063-019-3718-4.
Related trials for Split Thickness Skin Graft
Not yet recruiting
Autologous Skin Cell Suspension (RECELL®) for Accelerated Healing of Split-Thickness Skin Graft Donor Sites: A Randomized, Intra-Patient (Split-Site) Controlled Trial
Skin Graft Donor Site, Wound Healing
Recruiting
Lower Extremity Graft Study (LEGS): A Multicentre Randomised Controlled Trial of Negative Pressure Wound Therapy Versus Conventional Dressings for Split-thickness Skin Grafts After Lower Leg Skin Tumour Excision
Skin Transplantation, Skin Grafting
Enrolling by invitation
Clinical Effectiveness of a Patient-tailored Orthosis Based on 3-dimensional (3D) Scanner Modeling and 3D Printing Technology for Microstomia Caused by Burns : Pilot Study
Burn, 3D Printing
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.
Brigitte Dréno, Pr principal investigator
Nantes University Hospital
2 sites 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 biological dressing and Paraffin gauze dressing in people with Split Thickness Skin Graft and Wound Healing, run by Nantes University Hospital at 2 sites in France.
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 6 inclusion and 13 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 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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: It was decided to terminate the study prematurely due to insufficient enrolment, despite extensions to the enrolment period.). 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 healing (time frame: Day 8). 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 NCT03334656, which also lists 1 linked publication.
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 12 Aug 2024; AzTrials last refreshed its copy on 2 Nov 2026.