Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-30 @ 1:10 AM
Study NCT ID:
NCT00931567
Status:
COMPLETED
Last Update Posted:
2012-03-20
First Post:
2009-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Efficiency of Autologous Platelet Gel (Platelet Rich Fibrin) Obtained From Own Patients' Blood Versus Vaselitulle in Dupuytren's Disease Postoperative Wound Healing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004387', 'term': 'Dupuytren Contracture'}], 'ancestors': [{'id': 'D005350', 'term': 'Fibroma'}, {'id': 'D018218', 'term': 'Neoplasms, Fibrous Tissue'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D003286', 'term': 'Contracture'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-19', 'studyFirstSubmitDate': '2009-06-30', 'studyFirstSubmitQcDate': '2009-07-01', 'lastUpdatePostDateStruct': {'date': '2012-03-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time duration between the operation and the complete wound healing.', 'timeFrame': '18 months'}], 'secondaryOutcomes': [{'measure': "-The pain during the dressings' change using a visual scale going from 0 to 10. -The bleeding of the wound.", 'timeFrame': '18 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ["Dupuytren's Contracture"]}, 'referencesModule': {'references': [{'pmid': '23190833', 'type': 'DERIVED', 'citation': 'Chignon-Sicard B, Georgiou CA, Fontas E, David S, Dumas P, Ihrai T, Lebreton E. Efficacy of leukocyte- and platelet-rich fibrin in wound healing: a randomized controlled clinical trial. Plast Reconstr Surg. 2012 Dec;130(6):819e-829e. doi: 10.1097/PRS.0b013e31826d1711.'}]}, 'descriptionModule': {'briefSummary': 'This study is a clinical, multicentric, randomised open trial. The objective is to evaluate the efficiency, in terms of wound healing speed, of peroperative application of autologous platelets gel versus standardized wound dressing. The wound Healing model used in this study is the " open palm " surgical treatment of Dupuytren\'s disease.\n\nDupuytren\'s disease is a fibroproliferative disease of the palmar and digital fascia of the hand that may lead to a fixed flexion contracture of the fingers.\n\nThe main indication for surgery is the loss of finger extension. In some cases of palmar Dupuytren\'s disease the surgical removal of diseased tissues may lead to a cutaneous loss of substance (" open palm technique "). This loss of substance is treated using vaseline dressing and the wound healing is obtained in 4 weeks.\n\nAutologous platelets gel (Platelet Rich Fibrin) is obtained from the patient\'s own blood. Some recent studies have shown that it speeds up the wound healing and enhances the quality of the scar.\n\nPRF belongs to a new generation of autologous platelet gel that are easily obtained after centrifugation of patient\'s own blood.\n\nThe Platelet Rich Fibrin (PRF) contains many wound healing factors : Three pro inflammatory cytokines ( IL1,IL6, TNF-alpha) , one anti-inflammatory cytokine (IL4) and a growth factor (VEGF).\n\nThe study will be running on 60 days, starting from the operation day. The wound healing evaluation will be achieved at day1, day2, day7, day14, day 21 day 28 and day 60.\n\nThe inclusion criteria are : age over 18, Dupuytren\'s disease with an indication of surgical treatment using the open palm technique, patients having signed the agreement form.\n\n80 patients will be included in the study and divided into 2 groups . The first group of patients will receive PRF and the other group will receive vaseline dressings.\n\nThe speed and the quality of wound healing will be compared.We will also compare the number of patients with a complete wound healing at day 21 . Moreover,we will evaluate the pain during the dressings\' change and the bleeding of the palmar wound.\n\nFor the wound healing speed , a difference of 7 days between the two groups will be considered as statistically significant.\n\nStatistical analysis will be achieved using Chi2 test and Logrank test.', 'detailedDescription': 'Main evaluation criteria :\n\nTime duration between the operation and the complete wound healing. The wound healing is considered complete when the skin is closed and when the patient do not need to have dressings. A picture of the wound at the end of the wound healing process is taken for each patient.\n\nSecondary criteria of evaluation :\n\nAt day 1, day7, day 14, day 21 and day 28 two data will be collected :\n\n* The pain during the dressings\' change using a visual scale going from 0 (no pain) to 10 (very painful).\n* The bleeding (and "exudate") of the wound which can be absent, low, moderate or abundant.\n\nThe investigators will collect all the side effects described by the patients for each wound healing technique.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age \\> 18\n* Patient with Dupuytren's disease with an indication of surgical treatment using the open palm technique.\n* Agreement form signed\n* patient affiliated to the national health system.\n\nExclusion Criteria:\n\n* Patients allergic to one of the components of the dressings used in this study.\n* Patients with insulin-requiring diabetes\n* Patients sustaining anti-cancer treatment.\n* Pregnant women.\n* Patients included in another study.\n* Patients who cannot come to the follow up visits."}, 'identificationModule': {'nctId': 'NCT00931567', 'briefTitle': "Evaluation of the Efficiency of Autologous Platelet Gel (Platelet Rich Fibrin) Obtained From Own Patients' Blood Versus Vaselitulle in Dupuytren's Disease Postoperative Wound Healing", 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': "Evaluation of the Efficiency of Autologous Platelet Gel (Platelet Rich Fibrin) Obtained From Own Patients' Blood Versus Vaselitulle in Dupuytren's Disease Postoperative Wound Healing", 'orgStudyIdInfo': {'id': '01-APR-07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Vaselitulle', 'description': 'after surgery, the loss of substance is treated using vaseline dressing', 'interventionNames': ['Device: Vaselitulle']}, {'type': 'EXPERIMENTAL', 'label': 'Autologous platelets gel', 'description': 'after surgery, the loss of substance is treated with Autologous platelets gel', 'interventionNames': ['Biological: Autologous platelets gel']}], 'interventions': [{'name': 'Autologous platelets gel', 'type': 'BIOLOGICAL', 'description': 'Application of autologous platelets gel (Platelet Rich Fibrin) after the " open palm " surgical treatment of Dupuytren\'s disease.', 'armGroupLabels': ['Autologous platelets gel']}, {'name': 'Vaselitulle', 'type': 'DEVICE', 'description': 'application of standardized wound dressing after the " open palm " surgical treatment of Dupuytren\'s disease.', 'armGroupLabels': ['Vaselitulle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13385', 'city': 'Marseille', 'state': 'Cedex 05', 'country': 'France', 'facility': 'CHU Hôpital de la Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '06000', 'city': 'Nice', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Nice Hôpital de Cimiez', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Marseille', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}