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Use of Platelet-rich Plasma in Second-degree Superficial Burns

Primary Purpose

Burns Degree Second

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
PRP group
conventional treatment group
Sponsored by
Konya Meram State Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns Degree Second focused on measuring PRP, Burn

Eligibility Criteria

16 Years - 90 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • having a second-degree superficial burn
  • To be over the age of 16.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Konya Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

PRP group

conventional treatment group

Arm Description

Second-degree superficial burn group treated with PRP

second-degree superficial burn group treated with cream containing silver sulfadiazine

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 17, 2020
Last Updated
October 30, 2020
Sponsor
Konya Meram State Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04276818
Brief Title
Use of Platelet-rich Plasma in Second-degree Superficial Burns
Official Title
Use of Platelet-Rich Plasma in Second-Degree Superficial Burns; Multicentric Prospective Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
October 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Konya Meram State Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns Degree Second
Keywords
PRP, Burn

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PRP group
Arm Type
Active Comparator
Arm Description
Second-degree superficial burn group treated with PRP
Arm Title
conventional treatment group
Arm Type
Active Comparator
Arm Description
second-degree superficial burn group treated with cream containing silver sulfadiazine
Intervention Type
Procedure
Intervention Name(s)
PRP group
Intervention Description
Demonstrating the effectiveness of dressing with PRP in the treatment of second-degree burns
Intervention Type
Procedure
Intervention Name(s)
conventional treatment group
Intervention Description
The effectiveness of conventional dressing containing silver sulfadiazine in the treatment of burns will be compared with the method of dressing with PRP.
Primary Outcome Measure Information:
Title
PRP use in second degree burn treatment
Description
In the study, the effectiveness of burn treatment in both groups will be determined by recording the day of epithelialization.
Time Frame
01.03.2020-30.04.2020

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: having a second-degree superficial burn To be over the age of 16. Exclusion Criteria: 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.
Facility Information:
Facility Name
Konya Training and Research Hospital
City
Konya
ZIP/Postal Code
42090
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
I do not plan to share if it is not necessary
Citations:
PubMed Identifier
26822695
Citation
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.
Results Reference
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PubMed Identifier
20079572
Citation
Grippaudo 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.
Results Reference
background
PubMed Identifier
32048887
Citation
Zheng 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.
Results Reference
background

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Use of Platelet-rich Plasma in Second-degree Superficial Burns

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