Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:48 PM
Study NCT ID:
NCT00825851
Status:
COMPLETED
Last Update Posted:
2009-01-21
First Post:
2009-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Smoking, Abstention and Nicotine Replacement Therapy on Wound Healing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D061485', 'term': 'Tobacco Use Cessation Devices'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2001-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-01-20', 'studyFirstSubmitDate': '2009-01-20', 'studyFirstSubmitQcDate': '2009-01-20', 'lastUpdatePostDateStruct': {'date': '2009-01-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2000-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'wound healing', 'timeFrame': '1, 4, 8, and 12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Wound Healing']}, 'referencesModule': {'references': [{'pmid': '12832959', 'type': 'RESULT', 'citation': 'Sorensen LT, Karlsmark T, Gottrup F. Abstinence from smoking reduces incisional wound infection: a randomized controlled trial. Ann Surg. 2003 Jul;238(1):1-5. doi: 10.1097/01.SLA.0000074980.39700.31.'}]}, 'descriptionModule': {'briefSummary': 'The aim was to determine the wound healing capacity in healthy never smokers and smokers who continue to smoke, or quit smoking using transdermal nicotine patch versus placebo patch.', 'detailedDescription': 'Two wound healing models were applied: the excisional skin biopsy model to study wound histology and the suction blister model to study epidermal regeneration and skin transudate. In addition blood sampling was made to validate compliance to the study arms and to study systemic markers of collagen metabolism and oxidative stress. In addition, wound infections and wound ruptures were recorded post hoc as complications to the excisional skin biopsy model were not expected to occur.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* daily smokers smoking between 15-25 cigarettes per day and never smokers\n\nExclusion Criteria:\n\n* chronic medical disease\n* atopic dermatitis or other skin disease\n* pregnancy\n* menopause\n* allergy to dressings or patches\n* current or recent medication with corticosteroids or NSAID'}, 'identificationModule': {'nctId': 'NCT00825851', 'briefTitle': 'Effect of Smoking, Abstention and Nicotine Replacement Therapy on Wound Healing', 'organization': {'class': 'OTHER', 'fullName': 'Bispebjerg Hospital'}, 'officialTitle': 'Effect of Smoking, Abstention and Nicotine Replacement Therapy on Wound Healing', 'orgStudyIdInfo': {'id': 'smokaw_3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'continuous smoking', 'description': 'subjects smoke 20 cigarettes per day', 'interventionNames': ['Behavioral: Continuous smoking']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'smoking cessation and NRT', 'description': 'subjects quit smoking and use transdermal nicotine patch', 'interventionNames': ['Drug: Transdermal nicotine patch', 'Behavioral: Smoking cessation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'smoking cessation and placebo patch', 'description': 'subjects quit smoking and use placebo patch', 'interventionNames': ['Drug: Placebo patch', 'Behavioral: Smoking cessation']}, {'type': 'NO_INTERVENTION', 'label': 'never smokers', 'description': 'subjects being never smokers and who refrain from smoking'}], 'interventions': [{'name': 'Transdermal nicotine patch', 'type': 'DRUG', 'otherNames': ['Nicorette patch'], 'description': '15mg/16h + 10mg/16h to be used 24h', 'armGroupLabels': ['smoking cessation and NRT']}, {'name': 'Placebo patch', 'type': 'DRUG', 'armGroupLabels': ['smoking cessation and placebo patch']}, {'name': 'Smoking cessation', 'type': 'BEHAVIORAL', 'armGroupLabels': ['smoking cessation and NRT', 'smoking cessation and placebo patch']}, {'name': 'Continuous smoking', 'type': 'BEHAVIORAL', 'description': 'subjects smoke 20 cigarettes per day', 'armGroupLabels': ['continuous smoking']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2400', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Bispebjerg Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Lars T Sorensen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bispebjerg Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bispebjerg Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Danish Medical Research Council', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Copenhagen Wound Healing Center, Bispebjerg Hospital', 'oldOrganization': 'Bispebjerg Hospital'}}}}