Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2026-01-04 @ 4:56 PM
Study NCT ID:
NCT02246192
Status:
COMPLETED
Last Update Posted:
2015-03-19
First Post:
2014-08-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Plasma Rich in Growth Factors (PRGF) in Pilonidal Sinus Excision
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010864', 'term': 'Pilonidal Sinus'}], 'ancestors': [{'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-18', 'studyFirstSubmitDate': '2014-08-13', 'studyFirstSubmitQcDate': '2014-09-19', 'lastUpdatePostDateStruct': {'date': '2015-03-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'postoperative bleeding', 'timeFrame': '1 week'}, {'measure': 'surgical site infection rate', 'timeFrame': '1 month'}, {'measure': 'sinus recurrence rate', 'timeFrame': '4 years'}, {'measure': 'quality of life', 'timeFrame': '6 months', 'description': 'this measure is assessed asking the possibility of standing in Water closet(WC) or walking correctly.'}], 'primaryOutcomes': [{'measure': 'healing time(days) of pilonidal sinus wound excision', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'postoperative pain', 'timeFrame': '1 month', 'description': 'using VAS to assess postoperative pain'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pilonidal Sinus']}, 'descriptionModule': {'briefSummary': 'The use of plasma rich in growth factors in wound excision pilonidal sinus could improve the healing process of the wound, when compared with the usual technique of daily local healing. The investigators propose the objective of evaluating the efficacy of intra- and postoperative application of plasma rich in growth factors, to reduce healing time and complications, arising from its removal, compared to the standard surgical treatment.', 'detailedDescription': 'prospective randomized control trial, comparing PRGF application vs daily local care(betadine +saline) in sinus pilonidal wound excision. PRGF is extracted from de patient blood and infiltrated in the pilonidal wound every week. this treatment is compared with betadine and saline wound care in terms of wound healing time, pospoperative pain and other complications.\n\nthis study try to keeps the advantages of using open technique for pilonidal desease( low recurrence rate and surgical site infections) and improving the disadvantages (high wound healing time and postperative pain with wore quality of life) when it´s compared with direct closure or flap techniques.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients among 13 and 65 years old\n* Possibility of observation during the follow-up period\n* Patients who have read and signed informed consent\n\nExclusion Criteria:\n\n* Abscessed pilonidal sinus\n* Recurrent pilonidal sinus\n* Patients treated with immunosuppressive drugs or anticoagulants'}, 'identificationModule': {'nctId': 'NCT02246192', 'briefTitle': 'Use of Plasma Rich in Growth Factors (PRGF) in Pilonidal Sinus Excision', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Quiron Sagrado Corazon'}, 'officialTitle': 'Application of PRGF (Plasma Rich in Growth Factors) to Reduce the Healing Time After Pilonidal Sinus Excision. A Randomized 5-years Prospective Controlled Trial.', 'orgStudyIdInfo': {'id': 'Sinusprgf'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'control group', 'description': 'sinus pilonidal excision and standard cares', 'interventionNames': ['Procedure: sinus pilonidal excision and standard cares']}, {'type': 'EXPERIMENTAL', 'label': 'PRGF group', 'description': 'sinus pilonidal excision+ PRGF', 'interventionNames': ['Procedure: sinus pilonidal excision+ PRGF']}], 'interventions': [{'name': 'sinus pilonidal excision+ PRGF', 'type': 'PROCEDURE', 'description': 'open sinus pilonidal excision and plasma rich grow factor infiltration intra and postoperatively', 'armGroupLabels': ['PRGF group']}, {'name': 'sinus pilonidal excision and standard cares', 'type': 'PROCEDURE', 'description': 'sinus pilonidal excision and postoperative standard care with povidone daily', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Juan Bellido Luque', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Quirón Sagrado Corazón Hospital, Seville, Spain'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Quiron Sagrado Corazon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ph.D', 'investigatorFullName': 'Juan Bellido Luque.MD', 'investigatorAffiliation': 'Hospital Quiron Sagrado Corazon'}}}}