Completed

NCT Number: NCT04276818

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

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.

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Key information

Conditions

Burns Degree Second Burns Wounds and Injuries

Age range

16 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Konya Training and Research Hospital

Konya, 42090, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PRP group

Procedure

Demonstrating the effectiveness of dressing with PRP in the treatment of second-degree burns

Conventional Treatment group

Procedure

The effectiveness of conventional dressing containing silver sulfadiazine in the treatment of burns will be compared with the method of dressing with PRP.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Konya Meram State Hospital

Other

Registry information

Official study title

Use of Platelet-Rich Plasma in Second-Degree Superficial Burns; Multicentric Prospective Randomized Study

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: Feb 19, 2020
Registry last updated: Nov 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed