Skin BurnNCT05996614
Evaluation of Platelet Rich Plasma in Skin Graft Take for Patients With Post Burn Raw Areas
A study testing PRP in skin grafts and conventional methods in skin grafts in people with Skin Burn, run by Assiut University.
Trial summary
1. To evaluate the effect of the platelet rich plasma on the take of split thickness skin graft and its early and late results in resurfacing of post burn raw areas. 2. To evaluate the effect of PRP on wound healing on skin graft donor site. Read more about this study
- Who is it for?
- Ages 15 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Burn
- What is being tested?
- PRP in skin grafts and conventional methods in skin grafts
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to Feb 2025
- 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 15 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age (15- 60 years).
- Post burn Raw area less than 10 % of total body surface area .
- Selected donor sites.
Who cannot join
- Raw area due to other causes ( trauma, ischemia,..etc)
- Patients with bleeding tendency.
- Patients with comorbidities(diabetes, malignancy,..etc)
Trial locations and contacts
No sites are listed yet.
About this study
- To evaluate the effect of the platelet rich plasma on the take of split thickness skin graft and its early and late results in resurfacing of post burn raw areas.
- To evaluate the effect of PRP on wound healing on skin graft donor site.
Read the detailed description
Burn injuries involve tissue destruction due to energy transfer,The burn injuries can be caused by heat from hot liquids, solids or fire, an less common causes are friction, heat, chemical or electric sources The treatment of burns is complex due to the combination of hypermetabolic physiological response and the need for good functional and cosmetic recovery. Split thickness skin grafts (STSGs) are commonly used to resurface large areas of Post burn raw areas.
The time to complete wound healing ranged from 2 to 75 days. Factors that significantly affected time to complete wound healing were graft loss by seroma, presence of hypergranulation tissue, premorbid conditions, and total body surface area burned.
Generally, skin graft undertakes three steps for healing: anchorage, inosculation, and maturation. Haematoma, shearing, and infection on recipient sites of skin graft can reduce skin graft take, and even lead to skin graft loss.
Platelet-rich plasma (PRP) is an autologous blood-derived biomaterial that is enriched with a 2- to 6-fold concentration of platelets in comparison to normal human platelet concentration. Multiple growth factors and bioactive proteins are stored in α-granules of platelets. These growth factors can promote proliferation of endothelial cells, epithelial cells as well as fibroblasts, and increase angiogenesis. The potential clinical application of PRP in skin graft might rely on its haemostasis, adhesive, antibacterial and healing properties.
- Conditions
- Skin Burn
- Being tested
- PRP in skin grafts, conventional methods in skin grafts
- Medical subject headings
- Paresthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP in skin graftsProcedure or surgery
topical application of platelet rich plasma before resurfacing with STSG in Post burn raw areas
conventional methods in skin graftsProcedure or surgery
fixation of the graft with stitches and staplers
| Study group | Role | What they receive |
|---|---|---|
| group with PRP | Experimental | Group of patients with post burn raw areas treated with application of platelet rich plasma Receives: Procedure: PRP in skin grafts |
| group without PRP | Experimental | Group of patients with post burn raw areas treated with conventional methods Receives: Procedure: conventional methods in skin grafts |
What is being measured
The primary outcome is the main question the study is designed to answer.
histopathological biopsy from both groups by punch Biopsy (vancouver scale )
pigmentation (0-2) ,normal 0, Hypopigmentation 1 ,Hyperpigmentation 2 Vascularity (0-3) ,Normal 0, Pink 1, Red 2, Purple 3 Pliability (0-5) Normal 0 ,Supple 1 ,Yielding 2,Firm 3, Banding 4, Contracture 5 Height (0-3) Normal(flat)0 ,(0-2mm)1,(2-5mm)2,(>5mm)3
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 posted18 Aug 2023
- Study start1 Oct 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionFeb 2025 (estimated)
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 Skin BurnStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Ragab Ibrahim ali, Assiut University
- Investigators
- Mostafa Elsonbaty, prof, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05996614
- Sponsor's protocol ID
- PRP in skin grafts
- Status last verified
- Aug 2023
- First submitted
- 7 Oct 2022
- Last updated
- 18 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Garcia-Sanchez JM, Mirabet Lis V, Ruiz-Valls A, Perez-Plaza A, Sepulveda Sanchis P, Perez-Del-Caz MD. Platelet rich plasma and plasma rich in growth factors for split-thickness skin graft donor site treatment in the burn patient setting: A randomized clinical trial. Burns. 2022 Nov;48(7):1662-1670. doi: 10.1016/j.burns.2021.10.001. Epub 2021 Oct 22.
PubMed 34952738
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Platelet Rich Plasma in Skin Graft Take for Patients With Post Burn Raw Areas
- ClinicalTrials.gov ID
- NCT05996614
- Acronym / sponsor ID
- PRP in skin grafts
- Conditions
- Skin Burn
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 18 Aug 2023 (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.
- To evaluate the effect of the platelet rich plasma on the take of split thickness skin graft and its early and late results in resurfacing of post burn raw areas.
- To evaluate the effect of PRP on wound healing on skin graft donor site.
Detailed description
Burn injuries involve tissue destruction due to energy transfer,The burn injuries can be caused by heat from hot liquids, solids or fire, an less common causes are friction, heat, chemical or electric sources The treatment of burns is complex due to the combination of hypermetabolic physiological response and the need for good functional and cosmetic recovery. Split thickness skin grafts (STSGs) are commonly used to resurface large areas of Post burn raw areas.
The time to complete wound healing ranged from 2 to 75 days. Factors that significantly affected time to complete wound healing were graft loss by seroma, presence of hypergranulation tissue, premorbid conditions, and total body surface area burned.
Generally, skin graft undertakes three steps for healing: anchorage, inosculation, and maturation. Haematoma, shearing, and infection on recipient sites of skin graft can reduce skin graft take, and even lead to skin graft loss.
Platelet-rich plasma (PRP) is an autologous blood-derived biomaterial that is enriched with a 2- to 6-fold concentration of platelets in comparison to normal human platelet concentration. Multiple growth factors and bioactive proteins are stored in α-granules of platelets. These growth factors can promote proliferation of endothelial cells, epithelial cells as well as fibroblasts, and increase angiogenesis. The potential clinical application of PRP in skin graft might rely on its haemostasis, adhesive, antibacterial and healing properties.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group with PRP | Experimental | Procedure: PRP in skin graftsGroup of patients with post burn raw areas treated with application of platelet rich plasma |
| group without PRP | Experimental | Procedure: conventional methods in skin graftsGroup of patients with post burn raw areas treated with conventional methods |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age (15- 60 years).
- Post burn Raw area less than 10 % of total body surface area .
- Selected donor sites.
Key exclusion criteria (3 listed)
- Raw area due to other causes ( trauma, ischemia,..etc)
- Patients with bleeding tendency.
- Patients with comorbidities(diabetes, malignancy,..etc)
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 |
|---|---|---|
| PRP in skin graftstopical application of platelet rich plasma before resurfacing with STSG in Post burn raw areas | Procedure or surgery | group with PRP |
| conventional methods in skin graftsfixation of the graft with stitches and staplers | Procedure or surgery | group without PRP |
Primary outcome
histopathological biopsy from both groups by punch Biopsy (vancouver scale )
Time frame: 3 months
pigmentation (0-2) ,normal 0, Hypopigmentation 1 ,Hyperpigmentation 2 Vascularity (0-3) ,Normal 0, Pink 1, Red 2, Purple 3 Pliability (0-5) Normal 0 ,Supple 1 ,Yielding 2,Firm 3, Banding 4, Contracture 5 Height (0-3) Normal(flat)0 ,(0-2mm)1,(2-5mm)2,(>5mm)3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
- Results publication: PubMed 34952738Garcia-Sanchez JM, Mirabet Lis V, Ruiz-Valls A, Perez-Plaza A, Sepulveda Sanchis P, Perez-Del-Caz MD. Platelet rich plasma and plasma rich in growth factors for split-thickness skin graft donor site treatment in the burn patient setting: A randomized clinical trial. Burns. 2022 Nov;48(7):1662-1670. doi: 10.1016/j.burns.2021.10.001. Epub 2021 Oct 22.
- 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.
Mostafa Elsonbaty, prof study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing PRP in skin grafts and conventional methods in skin grafts in people with Skin Burn, 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 3 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 18 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ibrahim Ragab Ibrahim, master (00201060865454, himo_nimo9@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
histopathological biopsy from both groups by punch Biopsy (vancouver scale ) (time frame: 3 months). 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 NCT05996614, 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 18 Aug 2023.