Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT04276818
Status:
COMPLETED
Last Update Posted:
2020-11-02
First Post:
2020-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of Platelet-rich Plasma in Second-degree Superficial Burns
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-30', 'studyFirstSubmitDate': '2020-02-17', 'studyFirstSubmitQcDate': '2020-02-18', 'lastUpdatePostDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PRP use in second degree burn treatment', 'timeFrame': '01.03.2020-30.04.2020', 'description': 'In the study, the effectiveness of burn treatment in both groups will be determined by recording the day of epithelialization.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PRP', 'Burn'], 'conditions': ['Burns Degree Second']}, 'referencesModule': {'references': [{'pmid': '26822695', 'type': 'BACKGROUND', '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.'}, {'pmid': '20079572', 'type': 'BACKGROUND', '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.'}, {'pmid': '32048887', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nPRP 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.\n\nInvestigators planned a prospective randomized controlled and multicenter study to investigate the positive effects of PRP in the treatment of second-degree superficial burn.", 'detailedDescription': '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.\n\nPatients hospitalized with a second degree superficial burn and treated with PRP will be included in the study.\n\nPrimary 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.\n\nIn 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.\n\nPatients 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.\n\nThe 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.\n\nThe primary endpoint of the study was determined as the day when the burn was epithelialized 100%.\n\nSecondary endpoints are the deepening of the wound and the application of other treatment modalities, including surgery, or an infection in the burn area.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* having a second-degree superficial burn\n* To be over the age of 16.\n\nExclusion Criteria:\n\n* Patients under 16\n* Patients with a burn of more than 30% of the total body surface area.\n* Patients with additional trauma with a burn wound.\n* Diabetes mellitus, renal failure requiring dialysis and having decompensated heart disease\n* Being pregnant and breastfeeding.\n* The patient does not want to participate in the study.'}, 'identificationModule': {'nctId': 'NCT04276818', 'briefTitle': 'Use of Platelet-rich Plasma in Second-degree Superficial Burns', 'organization': {'class': 'OTHER', 'fullName': 'Konya Meram State Hospital'}, 'officialTitle': 'Use of Platelet-Rich Plasma in Second-Degree Superficial Burns; Multicentric Prospective Randomized Study', 'orgStudyIdInfo': {'id': 'SBU Konya EAH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PRP group', 'description': 'Second-degree superficial burn group treated with PRP', 'interventionNames': ['Procedure: PRP group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conventional treatment group', 'description': 'second-degree superficial burn group treated with cream containing silver sulfadiazine', 'interventionNames': ['Procedure: conventional treatment group']}], 'interventions': [{'name': 'PRP group', 'type': 'PROCEDURE', 'description': 'Demonstrating the effectiveness of dressing with PRP in the treatment of second-degree burns', 'armGroupLabels': ['PRP group']}, {'name': 'conventional treatment group', 'type': 'PROCEDURE', 'description': 'The effectiveness of conventional dressing containing silver sulfadiazine in the treatment of burns will be compared with the method of dressing with PRP.', 'armGroupLabels': ['conventional treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42090', 'city': 'Konya', 'country': 'Turkey (Türkiye)', 'facility': 'Konya Training and Research Hospital', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'I do not plan to share if it is not necessary'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Konya Meram State Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Alpaslan Şahin', 'investigatorAffiliation': 'Konya Meram State Hospital'}}}}