Ignite Creation Date:
2025-12-24 @ 9:38 PM
Ignite Modification Date:
2026-01-02 @ 12:50 PM
Study NCT ID:
NCT06849232
Status:
COMPLETED
Last Update Posted:
2025-02-27
First Post:
2025-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparative Study of Platelet-Rich Plasma and Normal Saline Dressings in the Treatment of Chronic Wounds (PRP-NS Wound T)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 156}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-24', 'studyFirstSubmitDate': '2025-02-08', 'studyFirstSubmitQcDate': '2025-02-24', 'lastUpdatePostDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wound Healing Rate', 'timeFrame': 'April 17, 2024, to October 16, 2024'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Wound Healing']}, 'descriptionModule': {'briefSummary': "This study aims to compare the effectiveness of Platelet-Rich Plasma (PRP) dressings versus Normal Saline dressings in the treatment of chronic wounds. Chronic wounds are slow-healing wounds that can cause significant discomfort, increase the risk of infections, and impact a patient's quality of life.\n\nPlatelet-Rich Plasma (PRP) is derived from the patient's own blood and contains growth factors that may help promote faster wound healing. On the other hand, Normal Saline dressings are commonly used as a standard wound care approach.\n\nParticipants in this study will be randomly assigned to receive either PRP dressings or normal saline dressings. The healing progress of their wounds will be monitored over a specified period to determine which treatment leads to better and faster healing.\n\nThe findings from this study may help improve wound care management and provide evidence for using PRP as an effective treatment for chronic wounds."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18-60 years of either gender were included if they had a chronic wound persisting for at least six weeks and with a size of at least 2 × 2 cm.\n\nExclusion Criteria:\n\n* Patients were excluded if their wounds had existed for less than six weeks, if they had a previous history of PRP dressing use, or if they had documented hypersensitivity to PRP.'}, 'identificationModule': {'nctId': 'NCT06849232', 'acronym': 'PRP-NS Wound T', 'briefTitle': 'A Comparative Study of Platelet-Rich Plasma and Normal Saline Dressings in the Treatment of Chronic Wounds (PRP-NS Wound T)', 'organization': {'class': 'OTHER', 'fullName': 'Quaid-e-Azam Medical College'}, 'officialTitle': 'A COMPARATIVE STUDY of PLATELET-RICH PLASMA and NORMAL SALINE DRESSINGS in the TREATMENT of CHRONIC WOUNDS', 'orgStudyIdInfo': {'id': '2381/DME/QAMC Bahawalpur'}, 'secondaryIdInfos': [{'id': '2381/DME/QAMC', 'type': 'OTHER', 'domain': 'Department of medical education, QAMC Bahawalpur'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PRP Dressing Group', 'description': "wounds were first cleaned with normal saline, followed by the injection of PRP, prepared from the patient's own blood by the hematology department, into the surrounding wound area twice weekly", 'interventionNames': ['Procedure: Platelet-Rich Plasma (PRP) Injections']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Normal Saline Dressing Group', 'interventionNames': ['Procedure: Platelet-Rich Plasma (PRP) Injections']}], 'interventions': [{'name': 'Platelet-Rich Plasma (PRP) Injections', 'type': 'PROCEDURE', 'description': "wounds were first cleaned with normal saline, followed by the injection of PRP, prepared from the patient's own blood by the hematology department, into the surrounding wound area twice weekly", 'armGroupLabels': ['Normal Saline Dressing Group', 'PRP Dressing Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63100', 'city': 'Bahawalpur', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Bahawal Victoria Hospital', 'geoPoint': {'lat': 29.39779, 'lon': 71.6752}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Quaid-e-Azam Medical College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Surgery', 'investigatorFullName': 'Shahid Hussain', 'investigatorAffiliation': 'Quaid-e-Azam Medical College'}}}}