Ignite Creation Date:
2025-12-24 @ 5:59 PM
Ignite Modification Date:
2025-12-24 @ 5:59 PM
Study NCT ID:
NCT04276168
Status:
UNKNOWN
Last Update Posted:
2020-08-19
First Post:
2020-02-17
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Iron Stores on Wound Healing in Plastic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018798', 'term': 'Anemia, Iron-Deficiency'}, {'id': 'D000072836', 'term': 'Surgical Wound'}], 'ancestors': [{'id': 'D000747', 'term': 'Anemia, Hypochromic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000090463', 'term': 'Iron Deficiencies'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-17', 'studyFirstSubmitDate': '2020-02-17', 'studyFirstSubmitQcDate': '2020-02-17', 'lastUpdatePostDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of good breast tissue healing on each breast', 'timeFrame': '15 days after surgery', 'description': 'Good healing is defined as a score of 0, 1 or 2 on a 16 points-specifc scale. The scale evaluate proportion of disunity for periareolar vertical and horizontal incisions'}], 'secondaryOutcomes': [{'measure': 'Evaluation of healing on the 16 points specific scale', 'timeFrame': '15 days after surgery'}, {'measure': 'Proportion of early complications', 'timeFrame': 'up to 15 days after surgery'}, {'measure': 'Proportion of closed drainage orifices', 'timeFrame': '15 days after surgery'}, {'measure': 'Correlation between serum ferritin levels before surgery and score on the healing scale', 'timeFrame': '15 days after surgery'}, {'measure': 'Intra-class correlation coefficient for the healing scale', 'timeFrame': '15 days after surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healing Wound', 'Iron-deficiency', 'Surgical Wound']}, 'descriptionModule': {'briefSummary': 'In breast reduction surgery, delayed wound healing may increase surgical site infections, cutaneous necrosis and may be related to psychological harm.Some risk factors have been identified : smoking, diabetes, overweight. A normal healing involve cellular and biochemical reactions in which iron plays an important role such as cellular respiration, redox reactions and regulation of genes involved in the cell cycle. This trial will study the relationship between iron stores and postoperative wound healing after bilateral breast reduction surgery in patients without preoperative anaemia.The primary outcome of this trial is the comparison of wound healing at post operative day 15, between patients with and without iron deficiency.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cohort of woman who had a scheduled bilateral breast reduction surgery without anemia', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\>18 years\n* female\n* scheduled bilateral breast reduction surgery\n* biological exams with ferritin and transferrin saturation coefficient taken the day before surgery\n* No anemia : haemoglobin \\>=12g/dL (preoperative biological assessment )\n* if genetic disease of haemoglobin, haemoglobin between 10 and 12g/dL and no Anaemia by iron deficiency\n* absence of clinical inflammatory syndrome (no clinical signs of infection or no fever)\n* non-opposition of the patient to participate\n\nExclusion Criteria:\n\n* Anaemia by iron deficiency'}, 'identificationModule': {'nctId': 'NCT04276168', 'acronym': 'IRONPLAST', 'briefTitle': 'Impact of Iron Stores on Wound Healing in Plastic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Impact of Iron Stores on Wound Healing in Plastic Surgery', 'orgStudyIdInfo': {'id': 'APHP190575'}}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'country': 'France', 'facility': 'Saint Louis hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Aristide Ntahe', 'role': 'CONTACT', 'email': 'aristide.ntahe@aphp.fr', 'phone': '0142495191'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}