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

Sponsor
Konya Meram State Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04276818
Collaborator
(none)
62
1
2
7.8
8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: PRP group
  • Procedure: conventional treatment group
N/A

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

Study Type:
Interventional
Actual Enrollment :
62 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Use of Platelet-Rich Plasma in Second-Degree Superficial Burns; Multicentric Prospective Randomized Study
Actual Study Start Date :
Mar 1, 2020
Actual Primary Completion Date :
Sep 30, 2020
Actual Study Completion Date :
Oct 23, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. PRP use in second degree burn treatment [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Konya Training and Research Hospital Konya Turkey 42090

Sponsors and Collaborators

  • Konya Meram State Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Alpaslan Şahin, Principal Investigator, Konya Meram State Hospital
ClinicalTrials.gov Identifier:
NCT04276818
Other Study ID Numbers:
  • SBU Konya EAH
First Posted:
Feb 19, 2020
Last Update Posted:
Nov 2, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Alpaslan Şahin, Principal Investigator, Konya Meram State Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 2, 2020