Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-01-24 @ 7:50 AM
Study NCT ID:
NCT02011802
Status:
COMPLETED
Last Update Posted:
2017-11-09
First Post:
2013-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sorbact TM: Effect of a Microbial Binding Dressing on Wound Healing After 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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 251}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-07', 'studyFirstSubmitDate': '2013-10-10', 'studyFirstSubmitQcDate': '2013-12-09', 'lastUpdatePostDateStruct': {'date': '2017-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of wounds healed', 'timeFrame': '75 days after surgery'}], 'secondaryOutcomes': [{'measure': 'Total surface area measure of non-healed wounds', 'timeFrame': '75 days after surgery'}, {'measure': 'VAS pain', 'timeFrame': 'every 2 weeks, from randomization up to 4 months or date of healing, whichever comes first'}, {'measure': 'analgesic use', 'timeFrame': 'every 2 weeks, from randomization up to 4 months or date of healing, whichever comes first'}, {'measure': 'antibiotics use', 'timeFrame': 'every 2 weeks, from randomization up to 4 months or date of healing, whichever comes first'}, {'measure': 'number of dressings used', 'timeFrame': 'every 2 weeks, from randomization up to 4 months or date of healing, whichever comes first'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sorbact TM', 'Alginates', 'Dressing', 'Wound healing'], 'conditions': ['Sinus Pilonidal']}, 'referencesModule': {'references': [{'pmid': '32020765', 'type': 'DERIVED', 'citation': 'Romain B, Mielcarek M, Delhorme JB, Meyer N, Brigand C, Rohr S; SORKYSA group. Dialkylcarbamoyl chloride-coated versus alginate dressings after pilonidal sinus excision: a randomized clinical trial (SORKYSA study). BJS Open. 2020 Apr;4(2):225-231. doi: 10.1002/bjs5.50259. Epub 2020 Feb 4.'}]}, 'descriptionModule': {'briefSummary': "Sinus pilonidal concern 26/100 000 young adults. It manifests after puberty, presenting as an acute abscess in approximately 50% of patients or as a discharging painful sinus. Patients may experience lengthy healing times resulting in considerable morbidity and disruption to a young adult's life. Eradication of pilonidal sinus is based on a wide surgical excision and at the end of the procedure, the wound is dressed with an alginate dressing (Algosteril®).\n\nThe objective is to show a better efficiency of Sorbact TM (trademark) dressings compared to Alginates that are standardized dressings after pilonidal sinus excision during a period of 75 days. The main objective is to show a difference of 20% of wounds completely healed in 75 days between the two types of dressing: 50% of wounds healed with Algosteril TM compared to 70% of wounds healed with Sorbact TM."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Man or woman over 18 years old\n* Informed consent signed by the participant\n* Affiliation to social security system\n* Having a pilonidal sinus:\n\n * Asymptomatic or discovered by the patient during a routine examination\n * With chronic recurrent infection and skin rupture\n\nExclusion Criteria:\n\n* Patients with concomitant pathology:\n\n * cancer treated by chemotherapy\n * Hypertension uncontrolled systolic blood pressure\\>180 mmHg or diastolic\\> 110 mmHg\n * Severe comorbidity with reduced life expectancy less than 12 months\n * Acute cardiovascular disease (myocardial infarction, stroke, recent heart surgery) within 3 months before inclusion\n* Patients participating in another clinical trial\n* Known for intolerance to one of the dressings\n* Known pregnancy\n* Uncontrolled diabetes (fasting glucose \\>2g/l)'}, 'identificationModule': {'nctId': 'NCT02011802', 'acronym': 'SORKYSA', 'briefTitle': 'Sorbact TM: Effect of a Microbial Binding Dressing on Wound Healing After Pilonidal Sinus Excision', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Sorbact TM: Effect of a Microbial Binding Dressing on Wound Healing After Pilonidal Sinus Excision', 'orgStudyIdInfo': {'id': '5568'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Algosteril TM', 'description': 'Calcium alginate dressings are made from seaweed. Calcium alginate dressings form a natural gel of the exudates against the healing tissue that keeps it moist and supple, aiding in healing and tissue growth. In addition, this gel material forms a natural barrier to bacteria that may complicate healing with secondary infections of the wound. Alginates are the reference of dressing after sinus pilonidal excision.', 'interventionNames': ['Device: Algosteril TM']}, {'type': 'EXPERIMENTAL', 'label': 'Sorbact TM', 'description': 'DACC (dialkylcarbamoyle chloride) is a main component of the bacterial binding wound dressing: Sorbact. DACC is a hydrophobic fatty acid derivative that can be used to coat dressing materials, resulting in a dressing with highly hydrophobic pathogen binding properties. This is a primary wound interface dressing and is effective when in close contact with the wound bed in a moist environment.', 'interventionNames': ['Device: Sorbact TM']}], 'interventions': [{'name': 'Algosteril TM', 'type': 'DEVICE', 'armGroupLabels': ['Algosteril TM']}, {'name': 'Sorbact TM', 'type': 'DEVICE', 'armGroupLabels': ['Sorbact TM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68024', 'city': 'Colmar', 'country': 'France', 'facility': 'Service de Chirurgie Digestive-Hôpital Pasteur-39 av de la Liberté', 'geoPoint': {'lat': 48.08078, 'lon': 7.35584}}, {'zip': '68100', 'city': 'Mulhouse', 'country': 'France', 'facility': 'Service de Chirurgie Digestive-Centre Hospitalier de Mulhouse- 20 av du Dr René Laennec', 'geoPoint': {'lat': 47.75205, 'lon': 7.32866}}, {'zip': '67700', 'city': 'Saverne', 'country': 'France', 'facility': 'Service de Chirurgie Générale Viscérale et Digestive-Centre Hospitalier de Saverne-19 Côte de Saverne', 'geoPoint': {'lat': 48.74164, 'lon': 7.36221}}, {'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Service de Chirurgie Digestive - Hôpital de Hautepierre- Hôpitaux Universitaires de Strasbourg - France', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'collaborators': [{'name': 'INRESA Pharma', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}