Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2025-12-26 @ 7:07 AM
Study NCT ID:
NCT05140161
Status:
UNKNOWN
Last Update Posted:
2021-12-01
First Post:
2021-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hemostasis Assesment After Application of Lyophilisate Collagen in Nail Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009263', 'term': 'Nails, Ingrown'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D009260', 'term': 'Nail Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 98}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-12-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2022-02-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-17', 'studyFirstSubmitDate': '2021-10-17', 'studyFirstSubmitQcDate': '2021-11-17', 'lastUpdatePostDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Recovery time', 'timeFrame': '3 weeks after surgery', 'description': 'Recovery time clinical indicators will be considered when there is absence of drainage, when granulation tissue is covered by a scab, when there were no signs of erythematous tissue without evidence of infection'}], 'primaryOutcomes': [{'measure': 'Bleeding', 'timeFrame': '72 hours after surgery', 'description': 'The polypropylene non-stick dressing together with 5 gauze pads from the same manufacturer will be weighed using a precision scale. 72 hours after surgery once the cohesive bandage has been removed, the gauze and the non-stick dressing in contact with the wounds will be weighed equally.'}], 'secondaryOutcomes': [{'measure': 'Postoperative pain', 'timeFrame': '72 hours after surgery', 'description': 'To measure the postoperative pain, an analog chromatic visual scale for self-evaluation of pain (scale from 0 =absence of pain to 10 =unbearable pain) will be used'}, {'measure': 'Postoperative inflammation', 'timeFrame': '72 hours after surgery', 'description': 'The digital circumference (in millimeters) will be measured using a flexible millimeter ruler at the level of the proximal nail fold'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['collagen', 'nail', 'ingrown', 'bleeding', 'surgery'], 'conditions': ['Nails, Ingrown', 'Coagulation Defect; Bleeding']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the hemostatic capacity of two types of collagen hemostatic sponges in nail surgery.\n\nIt is a randomized triple-blind clinical trial with two experimental groups (medium porosity collagen and high porosity collagen) and control group ( non collagen).', 'detailedDescription': 'To evaluate bleeding, all patients with onychocryptosis will be operated on with the same technique.\n\nIn the experimental groups, once the surgical procedure has been completed on both edges of the nail, hemostatic collagen will be applied in the experimental groups (experimental group 1- medium porosity collagen and experimental group 2-high porosity collagen) In all groups, including the control, once the intervention was finished, the same bandage was performed with the same number of gauze pads.\n\nAt 72 hours, the gauze set will be removed to weigh it using a precision balance and quantitatively evaluate the amount of bleeding.\n\nIn this way, a comparative study can be carried out between the 3 groups and determine if there are statistically significant differences or not, and can determine if lyophilized hemostatic collagen is useful in nail surgery and if there are significant differences between both experimental groups, determining if the percentage of porosity in a hemostatic is relevant in the hemostatic effect.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* STADIUM I, II, or III (Kline classification) without infective onychocryptosis (cellulitis) on both edges of the Hallux\n* Susceptible to phenol-alcohol technique with Suppan I modification\n\nExclusion Criteria:\n\n* Platelet Antiplatelet Therapy\n* Oral Anticoagulant Therapy\n* History of congenital or acquired Hemorrhagic Syndrome\n* Alteration in the following parameters (platelet count, prothrombin time, activated thromboplastin time, and plasma fibrinogen)'}, 'identificationModule': {'nctId': 'NCT05140161', 'briefTitle': 'Hemostasis Assesment After Application of Lyophilisate Collagen in Nail Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Seville'}, 'officialTitle': 'Hemostasis Assesment After Application of Lyophilisate Collagen in Nail Surgery: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '1206-N-15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Collagen 1', 'description': 'Medium porosity collagen sponge is used in the operated nail grooves. The hallux is covered with a non-stick dressing, five gauze surrounding it and a cohesive bandage', 'interventionNames': ['Device: collagen']}, {'type': 'EXPERIMENTAL', 'label': 'Collagen 2', 'description': 'High porosity collagen sponge is used in the operated nail grooves. The hallux is covered with a non-stick dressing, five gauze surrounding it and a cohesive bandage', 'interventionNames': ['Device: collagen']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'No hemostatic device is used in the nail grooves. No hemostatic device is used in the nail grooves. Only non-stick dressing, five gauze pads and cohesive bandage are used'}], 'interventions': [{'name': 'collagen', 'type': 'DEVICE', 'description': 'use of hemostatic device in order to reduce bleeding in nail surgery', 'armGroupLabels': ['Collagen 1', 'Collagen 2']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'ANTONIO CÓRDOBA FERNÁNDEZ, PHD', 'role': 'CONTACT', 'email': 'acordoba@us.es', 'phone': '+34 685860512'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'participant data will only be available to the principal researcher'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Seville', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD, Principal Investigator, Clinical Professor', 'investigatorFullName': 'Antonio Córdoba-Fernández PhD', 'investigatorAffiliation': 'University of Seville'}}}}