Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT04753060
Status:
SUSPENDED
Last Update Posted:
2021-02-12
First Post:
2021-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hair Cycle Modulation To Promote Human Wound Healing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'whyStopped': 'Study suspended temporarily due to coronavirus pandemic.', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2019-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-09', 'studyFirstSubmitDate': '2021-02-02', 'studyFirstSubmitQcDate': '2021-02-09', 'lastUpdatePostDateStruct': {'date': '2021-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Photograph Assessment', 'timeFrame': '7 days post-surgery', 'description': 'Digital assessment of healing outcome from clinical wound photographs using novel scale (1-10). Higher score is representative of a better outcome.'}, {'measure': 'Photograph Assessment', 'timeFrame': '14 days post-surgery', 'description': 'Digital assessment of healing outcome from clinical wound photographs using novel scale (1-10). Higher score is representative of a better outcome.'}, {'measure': 'Photograph Assessment', 'timeFrame': '3 months post-surgery', 'description': 'Digital assessment of healing outcome from clinical wound photographs using novel scale (1-10). Higher score is representative of a better outcome.'}], 'secondaryOutcomes': [{'measure': 'Post Operative Infection incidence', 'timeFrame': '7 days post surgery', 'description': 'Clinical assessment reports a presence or absence of infection'}, {'measure': 'Post Operative Infection incidence', 'timeFrame': '14 days post surgery', 'description': 'Clinical assessment reports a presence or absence of infection'}, {'measure': 'Post Operative Infection incidence', 'timeFrame': '3 months post surgery', 'description': 'Clinical assessment reports a presence or absence of infection'}, {'measure': 'Changes To Patient Microbiome (Next-Generation Sequencing)', 'timeFrame': '0, 7, 14 days and 3 months.', 'description': 'Changes to skin microbiome as compared to day 0 using next-generation sequencing.'}, {'measure': 'Histological Wound Healing Score', 'timeFrame': 'Day 0', 'description': 'H\\&E stained histological sections will be used to quantify healing using a study-specific scale (1-10). Higher score is representative of an improved outcome.'}, {'measure': 'Histological Wound Healing Score', 'timeFrame': '7 days post surgery', 'description': 'H\\&E stained histological sections will be used to quantify healing using a study-specific scale (1-10). Higher score is representative of an improved outcome.'}, {'measure': 'Histological Wound Healing Score', 'timeFrame': '14 days post surgery', 'description': 'H\\&E stained histological sections will be used to quantify healing using a study-specific scale (1-10). Higher score is representative of an improved outcome.'}, {'measure': 'Histological Wound Healing Score', 'timeFrame': '3 months post surgery', 'description': 'H\\&E stained histological sections will be used to quantify healing using a study-specific scale (1-10). Higher score is representative of an improved outcome.'}, {'measure': 'Identification of Hair Cycle State via Histology', 'timeFrame': 'Day 0', 'description': 'Tissue biopsies will be analysed histologically to identify the presence of anagen and telogen hair follicles.'}, {'measure': 'Identification of Hair Cycle State via Histology', 'timeFrame': '7 days post surgery', 'description': 'Tissue biopsies will be analysed histologically to identify the presence of anagen and telogen hair follicles.'}, {'measure': 'Identification of Hair Cycle State via Histology', 'timeFrame': '14 days post surgery', 'description': 'Tissue biopsies will be analysed histologically to identify the presence of anagen and telogen hair follicles.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Wound', 'Hair Follicle'], 'conditions': ['Wounds']}, 'descriptionModule': {'briefSummary': "Chronic wounds represent a huge burden to both patients and the National Health Service (NHS), with over 200,000 sufferers in the UK alone. Based on current conservative estimates the NHS spends £2.3 - £3.1 billion pounds every year treating these patients.\n\nThis study aims to reduce this shared burden, preliminary data from our research group using animal models has demonstrated variable ability of hair follicles to heal wounds based upon their stage within their growth cycle. This currently proposed study therefore aims to perform a simple novel intervention on patients prior to their elective surgery in an effort to replicate the substantial healing abilities noted in the animal models.\n\nUnder normal circumstances, a patient's operative site is shaved prior to the surgery for hygiene and visual simplicity. The aim of this study is to wax 50% of the patient's operative site prior to their surgery, the other half will be shaved on the day of surgery as per normal surgical protocol. Based on known data this waxing technique will cycle the hair follicles into their growth phase at the time of surgery. The growth phase of hair follicles corresponds with an increased ability to heal due to recruitment of a patients own stem cells. This study therefore aims to take advantage of the patient's own stem cell population. The 50% waxing and 50% shaving method upon each patients donor site allows us to directly compare the influence of these two methods directly on a patient-by-patient basis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is undergoing skin graft surgery\n* Patient is 18 years of age or older.\n* Written and informed consent provided.\n\nExclusion Criteria:\n\n* Participants that have been enrolled in a clinical trial within the last 3 months that would affect their ability to heal or influence hair cycle.\n* Specific hair-linked diseases, e.g. alopecia areata. (Not including androgenetic alopecia)\n* Lack of capacity to consent\n* Lymphedema\n* Malnutrition\n* Collagen disorders\n* Patients requiring grafts smaller than 5cm x 5cm\n* Patients requiring grafts wider than 10cm\n* Immunomodulation drugs\n* Patients will be excluded mid study if they develop an infection that prevents biopsy retrieval'}, 'identificationModule': {'nctId': 'NCT04753060', 'briefTitle': 'Hair Cycle Modulation To Promote Human Wound Healing', 'organization': {'class': 'OTHER', 'fullName': 'University of Hull'}, 'officialTitle': 'Hair Cycle Modulation To Promote Human Wound Healing', 'orgStudyIdInfo': {'id': 'RS105'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Waxing', 'description': 'Waxing of patients donor site who are undergoing a skingraft procedure, prior to surgery taking place.', 'interventionNames': ['Procedure: Waxing']}, {'type': 'NO_INTERVENTION', 'label': 'Standard care', 'description': 'Standard wound preparation'}], 'interventions': [{'name': 'Waxing', 'type': 'PROCEDURE', 'description': 'Donor sites of patients skin grafts are waxed prior to surgery for donor harvesting.', 'armGroupLabels': ['Waxing']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'HU16 5JQ', 'city': 'Hull', 'state': 'East Yorkshire', 'country': 'United Kingdom', 'facility': 'Castle Hill Hospital', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will not be shared but non-identifiable results will be published in an appropriate journal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Hull', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Health Service, United Kingdom', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Investigator', 'investigatorFullName': 'Matthew Hardman', 'investigatorAffiliation': 'University of Hull'}}}}