Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2026-03-11 @ 4:30 PM
Study NCT ID:
NCT04276818
Status:
COMPLETED
Last Update Posted:
2020-11-02
First Post:
2020-02-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Platelet-rich Plasma in Second-degree Superficial Burns
Sponsor:
Konya Meram State Hospital
Organization:
Study Overview
Official Title:
Use of Platelet-Rich Plasma in Second-Degree Superficial Burns; Multicentric Prospective Randomized Study
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: