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

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.

Study Overview

• Status: Completed
• Conditions: Burns Degree Second
• Intervention / Treatment: Procedure: PRP group; Procedure: conventional treatment group

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 Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Konya, Turkey, 42090
    • Konya Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PRP group; Second-degree superficial burn group treated with PRP	Procedure: PRP group; Demonstrating the effectiveness of dressing with PRP in the treatment of second-degree burns
Active Comparator: conventional treatment group; second-degree superficial burn group treated with cream containing silver sulfadiazine	Procedure: conventional treatment group; The effectiveness of conventional dressing containing silver sulfadiazine in the treatment of burns will be compared with the method of dressing with PRP.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	01.03.2020-30.04.2020

Collaborators and Investigators

• Sponsor: Konya Meram State Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): September 30, 2020
• Study Completion (Actual): October 23, 2020

Study Registration Dates

• First Submitted: February 17, 2020
• First Submitted That Met QC Criteria: February 18, 2020
• First Posted (Actual): February 19, 2020

Study Record Updates

• Last Update Posted (Actual): November 2, 2020
• Last Update Submitted That Met QC Criteria: October 30, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: PRP; Burn
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: SBU Konya EAH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: I do not plan to share if it is not necessary

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No