Burns Degree SecondNCT04276818
Use of Platelet-rich Plasma in Second-degree Superficial Burns
A study testing PRP group and conventional treatment group in people with Burns Degree Second, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
Trial summary
Platelet-rich plasma (PRP) obtained from the patient's blood has been used in many clinical and experimental studies, primarily wound healing, and successful results have been achieved. PRP has been used in various studies in the treatment of burn wounds, and positive results have been obtained. Read more about this study
- Who is it for?
- Ages 16 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Burns Degree Second
- What is being tested?
- PRP group and conventional treatment group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2020to 23 Oct 2020
- 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 16 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- having a second-degree superficial burn
- To be over the age of 16.
Who cannot join
- Patients under 16
- Patients with a burn of more than 30% of the total body surface area.
- Patients with additional trauma with a burn wound.
- Diabetes mellitus, renal failure requiring dialysis and having decompensated heart disease
- Being pregnant and breastfeeding.
- The patient does not want to participate in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Konya Training and Research Hospital
Konya, 42090
About this study
Official title: Use of Platelet-Rich Plasma in Second-Degree Superficial Burns; Multicentric Prospective Randomized Study
Platelet-rich plasma (PRP) obtained from the patient's blood has been used in many clinical and experimental studies, primarily wound healing, and successful results have been achieved.
PRP has been used in various studies in the treatment of burn wounds, and positive results have been obtained. However, investigators did not find any study or publication about the use of PRP in second-degree superficial burns in our screening.
Investigators planned a prospective randomized controlled and multicenter study to investigate the positive effects of PRP in the treatment of second-degree superficial burn.
Read the detailed description
The study was planned to be performed between 01.03.2020 and 01.04.2020 in Health Sciences University Konya Training and Research Hospital Burn Unit and Health Sciences University Mogadishu-Somalia Recep Tayyip Erdogan Training and Research Hospital General Surgery Clinics.
Patients hospitalized with a second degree superficial burn and treated with PRP will be included in the study.
Primary purpose: To investigate the effectiveness of platelet-rich plasma in burn treatment Secondary purpose: None. Platelet-rich plasma has recently been used in medicine for the treatment of various diseases.
In our study, patients hospitalized in our clinic with the diagnosis of second-degree superficial burn were randomized and divided into two equal groups. It was planned to treat the first group with PRP, and the second group to be treated with a conventional method of dressing containing silver sulfadiazine cream.
Patients will be given clear and understandable information about the study. Patients who agree to participate in the study will receive a consent form explaining that they have participated in the study voluntarily.
The secretary will do randomization with the help of a computer program. A note stating which group the patient is in will be placed in a closed envelope. A randomization envelope will be opened in each patient before starting treatment.
The primary endpoint of the study was determined as the day when the burn was epithelialized 100%.
Secondary endpoints are the deepening of the wound and the application of other treatment modalities, including surgery, or an infection in the burn area.
In our power analysis, investigators found the number of patients as 80% power and 28 patients with an alpha value of 0.05. Assuming that 10% of patients will be excluded during the study, investigators calculated that a total of 31 patients should be studied.
- Conditions
- Burns Degree Second
- Being tested
- PRP group, conventional treatment group
- Keywords
- PRP, Burn
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP groupProcedure or surgery
Demonstrating the effectiveness of dressing with PRP in the treatment of second-degree burns
conventional treatment groupProcedure or surgery
The effectiveness of conventional dressing containing silver sulfadiazine in the treatment of burns will be compared with the method of dressing with PRP.
| Study group | Role | What they receive |
|---|---|---|
| PRP group | Active comparator | Second-degree superficial burn group treated with PRP Receives: Procedure: PRP group |
| conventional treatment group | Active comparator | second-degree superficial burn group treated with cream containing silver sulfadiazine Receives: Procedure: conventional treatment group |
What is being measured
The primary outcome is the main question the study is designed to answer.
PRP use in second degree burn treatment
In the study, the effectiveness of burn treatment in both groups will be determined by recording the day of epithelialization.
Measured: 01.03.2020-30.04.2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start1 Mar 2020
- Primary completion30 Sep 2020
- Study completion23 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Burns Degree SecondStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya Meram State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alpaslan Şahin, Konya Meram State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04276818
- Sponsor's protocol ID
- SBU Konya EAH
- Status last verified
- Oct 2020
- First submitted
- 17 Feb 2020
- Last updated
- 2 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I do not plan to share if it is not necessary
Publications
Venter NG, Marques RG, Santos JS, Monte-Alto-Costa A. Use of platelet-rich plasma in deep second- and third-degree burns. Burns. 2016 Jun;42(4):807-14. doi: 10.1016/j.burns.2016.01.002. Epub 2016 Jan 25.
PubMed 26822695Grippaudo FR, Carini L, Baldini R. Procutase versus 1% silver sulphadiazine in the treatment of minor burns. Burns. 2010 Sep;36(6):871-5. doi: 10.1016/j.burns.2009.10.021. Epub 2010 Jan 15.
PubMed 20079572Zheng W, Zhao DL, Zhao YQ, Li ZY. Effectiveness of platelet rich plasma in burn wound healing: a systematic review and meta-analysis. J Dermatolog Treat. 2022 Feb;33(1):131-137. doi: 10.1080/09546634.2020.1729949. Epub 2020 Feb 21.
PubMed 32048887
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Platelet-Rich Plasma in Second-Degree Superficial Burns; Multicentric Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT04276818
- Acronym / sponsor ID
- SBU Konya EAH
- Conditions
- Burns Degree Second
- Keywords
- PRP, Burn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Konya Meram State HospitalUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 23 Oct 2020 (actual)
- First posted
- 19 Feb 2020 (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.
Platelet-rich plasma (PRP) obtained from the patient's blood has been used in many clinical and experimental studies, primarily wound healing, and successful results have been achieved.
PRP has been used in various studies in the treatment of burn wounds, and positive results have been obtained. However, investigators did not find any study or publication about the use of PRP in second-degree superficial burns in our screening.
Investigators planned a prospective randomized controlled and multicenter study to investigate the positive effects of PRP in the treatment of second-degree superficial burn.
Detailed description
The study was planned to be performed between 01.03.2020 and 01.04.2020 in Health Sciences University Konya Training and Research Hospital Burn Unit and Health Sciences University Mogadishu-Somalia Recep Tayyip Erdogan Training and Research Hospital General Surgery Clinics.
Patients hospitalized with a second degree superficial burn and treated with PRP will be included in the study.
Primary purpose: To investigate the effectiveness of platelet-rich plasma in burn treatment Secondary purpose: None. Platelet-rich plasma has recently been used in medicine for the treatment of various diseases.
In our study, patients hospitalized in our clinic with the diagnosis of second-degree superficial burn were randomized and divided into two equal groups. It was planned to treat the first group with PRP, and the second group to be treated with a conventional method of dressing containing silver sulfadiazine cream.
Patients will be given clear and understandable information about the study. Patients who agree to participate in the study will receive a consent form explaining that they have participated in the study voluntarily.
The secretary will do randomization with the help of a computer program. A note stating which group the patient is in will be placed in a closed envelope. A randomization envelope will be opened in each patient before starting treatment.
The primary endpoint of the study was determined as the day when the burn was epithelialized 100%.
Secondary endpoints are the deepening of the wound and the application of other treatment modalities, including surgery, or an infection in the burn area.
In our power analysis, investigators found the number of patients as 80% power and 28 patients with an alpha value of 0.05. Assuming that 10% of patients will be excluded during the study, investigators calculated that a total of 31 patients should be studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRP group | Active comparator | Procedure: PRP groupSecond-degree superficial burn group treated with PRP |
| conventional treatment group | Active comparator | Procedure: conventional treatment groupsecond-degree superficial burn group treated with cream containing silver sulfadiazine |
Who may qualify
- Ages
- 16 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- having a second-degree superficial burn
- To be over the age of 16.
Key exclusion criteria (6 listed)
- Patients under 16
- Patients with a burn of more than 30% of the total body surface area.
- Patients with additional trauma with a burn wound.
- Diabetes mellitus, renal failure requiring dialysis and having decompensated heart disease
- Being pregnant and breastfeeding.
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 groupDemonstrating the effectiveness of dressing with PRP in the treatment of second-degree burns | Procedure or surgery | PRP group |
| conventional treatment groupThe effectiveness of conventional dressing containing silver sulfadiazine in the treatment of burns will be compared with the method of dressing with PRP. | Procedure or surgery | conventional treatment group |
Primary outcome
PRP use in second degree burn treatment
Time frame: 01.03.2020-30.04.2020
In the study, the effectiveness of burn treatment in both groups will be determined by recording the day of epithelialization.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
- Background: PubMed 26822695Venter NG, Marques RG, Santos JS, Monte-Alto-Costa A. Use of platelet-rich plasma in deep second- and third-degree burns. Burns. 2016 Jun;42(4):807-14. doi: 10.1016/j.burns.2016.01.002. Epub 2016 Jan 25.
- Background: PubMed 20079572Grippaudo FR, Carini L, Baldini R. Procutase versus 1% silver sulphadiazine in the treatment of minor burns. Burns. 2010 Sep;36(6):871-5. doi: 10.1016/j.burns.2009.10.021. Epub 2010 Jan 15.
- Background: PubMed 32048887Zheng W, Zhao DL, Zhao YQ, Li ZY. Effectiveness of platelet rich plasma in burn wound healing: a systematic review and meta-analysis. J Dermatolog Treat. 2022 Feb;33(1):131-137. doi: 10.1080/09546634.2020.1729949. Epub 2020 Feb 21.
- Individual participant dataSharing planned: No. I do not plan to share if it is not necessary
Related trials for Burns Degree Second
Not yet recruiting
Impact of Range of Motion Exercises on Pain and Functional Ability
Impact of ROM Exercises on Pain and Functional Ability in Patients With Second -Degree Burns
Not yet recruitingObservational study
Phoenixin and Pain in Pediatric Burn Patients
Children, Acute Pain
Not yet recruitingObservational study
The Use of Cultured (Dermal) Epithelial Autografts in Severely Burned Patients
Burn Degree Second, Burn Degree Third
Not yet recruiting
Development and Clinical Study of Burn Wound Nursing Dressing Based on Sodium Hyaluronate Carbomer Composite Hydrogel
Burn, Burn Contracture of Skin
Not yet recruitingObservational study
Cell Suspension With Biologic Dressing for Burn Wounds
Wound Healing
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRP group and conventional treatment group in people with Burns Degree Second, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
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 6 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: finished, as of the sponsor's last update on 2 Nov 2020. 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 Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
PRP use in second degree burn treatment (time frame: 01.03.2020-30.04.2020). 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 NCT04276818, which also lists 3 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 2 Nov 2020.