Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-31 @ 1:16 AM
Study NCT ID:
NCT01225250
Status:
COMPLETED
Last Update Posted:
2020-11-04
First Post:
2010-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy Study of Polydioxanone (PDS) Plates in Rhinoplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001860', 'term': 'Bone Plates'}], 'ancestors': [{'id': 'D016268', 'term': 'Internal Fixators'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D009984', 'term': 'Orthopedic Fixation Devices'}, {'id': 'D009983', 'term': 'Orthopedic Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D053831', 'term': 'Surgical Fixation Devices'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sdayan@drdayan.com', 'phone': '3123352070', 'title': 'Steven Dayan, MD', 'organization': 'DeNova Research'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Polydioxanone (PDS) Plates', 'description': '15 subjects will be randomized to receive a caudal septal extension graft using a PDS plated cartilagenous graft\n\nPolydioxanone (PDS) plates: 0.5 mm PDS Flexible Plate made of poly-p-dioxanone, an aliphatic polyester which is manufactured by polymerization of the monomer p-dioxanone. Polydioxanone is a resorbable material degraded by hydrolysis and has been successfully used for bone discontinuities and septal reconstruction.\n\nCaudal septal extension graft performed through endonasal rhinoplasty: The caudal septal extension (CSE) graft is a common method used to alter tip projection, alar-columellar relationship, and nasolabial angle.5 However, it can be difficult to stabilize and straighten the CSE graft, especially when performed through an endonasal approach. Use of a polydioxanone plate would provide a scaffolding for the CSE graft and could allow for a technically easier and more predictable surgical procedure.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Non-plated Cartilagenous Graft', 'description': '15 subjects will be randomized to receive a cartilagenous caudal septal extension fgraft\n\nCaudal septal extension graft performed through endonasal rhinoplasty: The caudal septal extension (CSE) graft is a common method used to alter tip projection, alar-columellar relationship, and nasolabial angle.5 However, it can be difficult to stabilize and straighten the CSE graft, especially when performed through an endonasal approach. Use of a polydioxanone plate would provide a scaffolding for the CSE graft and could allow for a technically easier and more predictable surgical procedure.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Live Assessment of Satisfaction With the Grafts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Polydioxanone (PDS) Plates', 'description': '15 subjects will be randomized to receive a caudal septal extension graft using a PDS plated cartilagenous graft\n\nPolydioxanone (PDS) plates: 0.5 mm PDS Flexible Plate made of poly-p-dioxanone, an aliphatic polyester which is manufactured by polymerization of the monomer p-dioxanone. Polydioxanone is a resorbable material degraded by hydrolysis and has been successfully used for bone discontinuities and septal reconstruction.\n\nCaudal septal extension graft performed through endonasal rhinoplasty: The caudal septal extension (CSE) graft is a common method used to alter tip projection, alar-columellar relationship, and nasolabial angle.5 However, it can be difficult to stabilize and straighten the CSE graft, especially when performed through an endonasal approach. Use of a polydioxanone plate would provide a scaffolding for the CSE graft and could allow for a technically easier and more predictable surgical procedure.'}, {'id': 'OG001', 'title': 'Non-plated Cartilagenous Graft', 'description': '15 subjects will be randomized to receive a cartilagenous caudal septal extension fgraft\n\nCaudal septal extension graft performed through endonasal rhinoplasty: The caudal septal extension (CSE) graft is a common method used to alter tip projection, alar-columellar relationship, and nasolabial angle.5 However, it can be difficult to stabilize and straighten the CSE graft, especially when performed through an endonasal approach. Use of a polydioxanone plate would provide a scaffolding for the CSE graft and could allow for a technically easier and more predictable surgical procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'spread': '0.667', 'groupId': 'OG000'}, {'value': '4', 'spread': '0.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months post operative', 'description': 'Efficacy will be determined by a live assessment of satisfaction with the grafts at 12 months using a four-point categorical satisfaction scale ((4) unsatisfied, (3) satisfied, (2) very satisfied, (1) highly satisfied).\n\nScores closer to 1 indicate a more favorable outcome', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Assessment of Tip Projection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Polydioxanone (PDS) Plates', 'description': '15 subjects will be randomized to receive a caudal septal extension graft using a PDS plated cartilagenous graft\n\nPolydioxanone (PDS) plates: 0.5 mm PDS Flexible Plate made of poly-p-dioxanone, an aliphatic polyester which is manufactured by polymerization of the monomer p-dioxanone. Polydioxanone is a resorbable material degraded by hydrolysis and has been successfully used for bone discontinuities and septal reconstruction.\n\nCaudal septal extension graft performed through endonasal rhinoplasty: The caudal septal extension (CSE) graft is a common method used to alter tip projection, alar-columellar relationship, and nasolabial angle.5 However, it can be difficult to stabilize and straighten the CSE graft, especially when performed through an endonasal approach. Use of a polydioxanone plate would provide a scaffolding for the CSE graft and could allow for a technically easier and more predictable surgical procedure.'}, {'id': 'OG001', 'title': 'Non-plated Cartilagenous Graft', 'description': '15 subjects will be randomized to receive a cartilagenous caudal septal extension fgraft\n\nCaudal septal extension graft performed through endonasal rhinoplasty: The caudal septal extension (CSE) graft is a common method used to alter tip projection, alar-columellar relationship, and nasolabial angle.5 However, it can be difficult to stabilize and straighten the CSE graft, especially when performed through an endonasal approach. Use of a polydioxanone plate would provide a scaffolding for the CSE graft and could allow for a technically easier and more predictable surgical procedure.'}], 'classes': [{'title': 'Month 1', 'categories': [{'measurements': [{'value': '0.55', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '0.58', 'spread': '0.05', 'groupId': 'OG001'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '0.54', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '0.58', 'spread': '0.04', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '0.54', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '0.57', 'spread': '0.03', 'groupId': 'OG001'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '0.55', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '0.55', 'spread': '0.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months Post opeartive', 'description': "Tip projection will be measured using standardized photography preoperatively and at 1 month, 3 months, 6 months, and 12 months postoperatively using Goode's Ratio.\n\nThe ratio of the line from the alar crease to the nasal tip to the nasion to the nasal tip should be 0.55. If it is more than that the nose is over projected, if it is under that ratio the nose is under projected.", 'unitOfMeasure': 'ratio of tip projection to nasal length', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Non-treating Blinded Evaluator Satisfaction Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Polydioxanone (PDS) Plates', 'description': '15 subjects will be randomized to receive a caudal septal extension graft using a PDS plated cartilagenous graft\n\nPolydioxanone (PDS) plates: 0.5 mm PDS Flexible Plate made of poly-p-dioxanone, an aliphatic polyester which is manufactured by polymerization of the monomer p-dioxanone. Polydioxanone is a resorbable material degraded by hydrolysis and has been successfully used for bone discontinuities and septal reconstruction.\n\nCaudal septal extension graft performed through endonasal rhinoplasty: The caudal septal extension (CSE) graft is a common method used to alter tip projection, alar-columellar relationship, and nasolabial angle.5 However, it can be difficult to stabilize and straighten the CSE graft, especially when performed through an endonasal approach. Use of a polydioxanone plate would provide a scaffolding for the CSE graft and could allow for a technically easier and more predictable surgical procedure.'}, {'id': 'OG001', 'title': 'Non-plated Cartilagenous Graft', 'description': '15 subjects will be randomized to receive a cartilagenous caudal septal extension fgraft\n\nCaudal septal extension graft performed through endonasal rhinoplasty: The caudal septal extension (CSE) graft is a common method used to alter tip projection, alar-columellar relationship, and nasolabial angle.5 However, it can be difficult to stabilize and straighten the CSE graft, especially when performed through an endonasal approach. Use of a polydioxanone plate would provide a scaffolding for the CSE graft and could allow for a technically easier and more predictable surgical procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'spread': '1', 'groupId': 'OG000'}, {'value': '2', 'spread': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Assessed at baseline, 1 month, 3 months, 6 months, and 12 months; Month 12 reported', 'description': "A non-treating blinded evaluator will assess satisfaction with a four-point categorical satisfaction scale ((4) - unsatisfied, (3) - satisfied, (2) - very satisfied, (1) - highly satisfied) of subject's grafts using photographs from baseline, 1 month, 3 months, 6 months, and 12 months and will consist of a blinded evaluation in which the physician is aware of the type of graft, but unaware of plating status or the specific grafting site.\n\nScores closer to 1 indicate a more favorable outcome", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Ease of Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Polydioxanone (PDS) Plates', 'description': '15 subjects will be randomized to receive a caudal septal extension graft using a PDS plated cartilagenous graft\n\nPolydioxanone (PDS) plates: 0.5 mm PDS Flexible Plate made of poly-p-dioxanone, an aliphatic polyester which is manufactured by polymerization of the monomer p-dioxanone. Polydioxanone is a resorbable material degraded by hydrolysis and has been successfully used for bone discontinuities and septal reconstruction.\n\nCaudal septal extension graft performed through endonasal rhinoplasty: The caudal septal extension (CSE) graft is a common method used to alter tip projection, alar-columellar relationship, and nasolabial angle.5 However, it can be difficult to stabilize and straighten the CSE graft, especially when performed through an endonasal approach. Use of a polydioxanone plate would provide a scaffolding for the CSE graft and could allow for a technically easier and more predictable surgical procedure.'}, {'id': 'OG001', 'title': 'Non-plated Cartilagenous Graft', 'description': '15 subjects will be randomized to receive a cartilagenous caudal septal extension fgraft\n\nCaudal septal extension graft performed through endonasal rhinoplasty: The caudal septal extension (CSE) graft is a common method used to alter tip projection, alar-columellar relationship, and nasolabial angle.5 However, it can be difficult to stabilize and straighten the CSE graft, especially when performed through an endonasal approach. Use of a polydioxanone plate would provide a scaffolding for the CSE graft and could allow for a technically easier and more predictable surgical procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'spread': '9.95', 'groupId': 'OG000'}, {'value': '46.4', 'spread': '13.43', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 hour following surgery', 'description': 'Ease of use will be determined by the treating investigator using a 10 cm Visual Analog Scale (VAS) to demonstrate technical ease with a score of 0 mm being easy and a scale of 100 mm being extremely difficult.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Infection, Rejection, and Extrusion of the Graft at 1 Week, 1 Month, 3 Months, 6 Months, and 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Polydioxanone (PDS) Plates', 'description': '15 subjects will be randomized to receive a caudal septal extension graft using a PDS plated cartilagenous graft\n\nPolydioxanone (PDS) plates: 0.5 mm PDS Flexible Plate made of poly-p-dioxanone, an aliphatic polyester which is manufactured by polymerization of the monomer p-dioxanone. Polydioxanone is a resorbable material degraded by hydrolysis and has been successfully used for bone discontinuities and septal reconstruction.\n\nCaudal septal extension graft performed through endonasal rhinoplasty: The caudal septal extension (CSE) graft is a common method used to alter tip projection, alar-columellar relationship, and nasolabial angle.5 However, it can be difficult to stabilize and straighten the CSE graft, especially when performed through an endonasal approach. Use of a polydioxanone plate would provide a scaffolding for the CSE graft and could allow for a technically easier and more predictable surgical procedure.'}, {'id': 'OG001', 'title': 'Non-plated Cartilagenous Graft', 'description': '15 subjects will be randomized to receive a cartilagenous caudal septal extension fgraft\n\nCaudal septal extension graft performed through endonasal rhinoplasty: The caudal septal extension (CSE) graft is a common method used to alter tip projection, alar-columellar relationship, and nasolabial angle.5 However, it can be difficult to stabilize and straighten the CSE graft, especially when performed through an endonasal approach. Use of a polydioxanone plate would provide a scaffolding for the CSE graft and could allow for a technically easier and more predictable surgical procedure.'}], 'classes': [{'title': 'Week 1 - Infection', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Week 1 - Rejection', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 1 - Extrusion', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 1 - Infection', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 1 - Rejection', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 1 - Extrusion', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 3 - Infection', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 3 - Rejection', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 3 - Extrusion', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 6 - Infection', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 6 - Rejection', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 6 - Extrusion', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 12 - Infection', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 12 - Rejection', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 12 - Extrusion', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months post surgery', 'description': 'Safety will be determined by rate of infection, rejection, and extrusion of the graft at 1 week, 1 month, 3 months, 6 months, and 12 months.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Intraoperative Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Polydioxanone (PDS) Plates', 'description': '15 subjects will be randomized to receive a caudal septal extension graft using a PDS plated cartilagenous graft\n\nPolydioxanone (PDS) plates: 0.5 mm PDS Flexible Plate made of poly-p-dioxanone, an aliphatic polyester which is manufactured by polymerization of the monomer p-dioxanone. Polydioxanone is a resorbable material degraded by hydrolysis and has been successfully used for bone discontinuities and septal reconstruction.\n\nCaudal septal extension graft performed through endonasal rhinoplasty: The caudal septal extension (CSE) graft is a common method used to alter tip projection, alar-columellar relationship, and nasolabial angle.5 However, it can be difficult to stabilize and straighten the CSE graft, especially when performed through an endonasal approach. Use of a polydioxanone plate would provide a scaffolding for the CSE graft and could allow for a technically easier and more predictable surgical procedure.'}, {'id': 'OG001', 'title': 'Non-plated Cartilagenous Graft', 'description': '15 subjects will be randomized to receive a cartilagenous caudal septal extension fgraft\n\nCaudal septal extension graft performed through endonasal rhinoplasty: The caudal septal extension (CSE) graft is a common method used to alter tip projection, alar-columellar relationship, and nasolabial angle.5 However, it can be difficult to stabilize and straighten the CSE graft, especially when performed through an endonasal approach. Use of a polydioxanone plate would provide a scaffolding for the CSE graft and could allow for a technically easier and more predictable surgical procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '604.7', 'spread': '219.12', 'groupId': 'OG000'}, {'value': '571.5', 'spread': '182.16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During surgery (up to 3 hours)', 'description': 'The intraoperative duration of the grafting procedure will be measured by an assistant using a stopwatch to record the time it takes to harvest, shape, and satisfactorily secure the graft.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Polydioxanone (PDS) Plates', 'description': '15 subjects will be randomized to receive a caudal septal extension graft using a PDS plated cartilagenous graft\n\nPolydioxanone (PDS) plates: 0.5 mm PDS Flexible Plate made of poly-p-dioxanone, an aliphatic polyester which is manufactured by polymerization of the monomer p-dioxanone. Polydioxanone is a resorbable material degraded by hydrolysis and has been successfully used for bone discontinuities and septal reconstruction.\n\nCaudal septal extension graft performed through endonasal rhinoplasty: The caudal septal extension (CSE) graft is a common method used to alter tip projection, alar-columellar relationship, and nasolabial angle.5 However, it can be difficult to stabilize and straighten the CSE graft, especially when performed through an endonasal approach. Use of a polydioxanone plate would provide a scaffolding for the CSE graft and could allow for a technically easier and more predictable surgical procedure.'}, {'id': 'FG001', 'title': 'Non-plated Cartilagenous Graft', 'description': '15 subjects will be randomized to receive a cartilagenous caudal septal extension fgraft\n\nCaudal septal extension graft performed through endonasal rhinoplasty: The caudal septal extension (CSE) graft is a common method used to alter tip projection, alar-columellar relationship, and nasolabial angle.5 However, it can be difficult to stabilize and straighten the CSE graft, especially when performed through an endonasal approach. Use of a polydioxanone plate would provide a scaffolding for the CSE graft and could allow for a technically easier and more predictable surgical procedure.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Polydioxanone (PDS) Plates', 'description': '15 subjects will be randomized to receive a caudal septal extension graft using a PDS plated cartilagenous graft\n\nPolydioxanone (PDS) plates: 0.5 mm PDS Flexible Plate made of poly-p-dioxanone, an aliphatic polyester which is manufactured by polymerization of the monomer p-dioxanone. Polydioxanone is a resorbable material degraded by hydrolysis and has been successfully used for bone discontinuities and septal reconstruction.\n\nCaudal septal extension graft performed through endonasal rhinoplasty: The caudal septal extension (CSE) graft is a common method used to alter tip projection, alar-columellar relationship, and nasolabial angle.5 However, it can be difficult to stabilize and straighten the CSE graft, especially when performed through an endonasal approach. Use of a polydioxanone plate would provide a scaffolding for the CSE graft and could allow for a technically easier and more predictable surgical procedure.'}, {'id': 'BG001', 'title': 'Non-plated Cartilagenous Graft', 'description': '15 subjects will be randomized to receive a cartilagenous caudal septal extension fgraft\n\nCaudal septal extension graft performed through endonasal rhinoplasty: The caudal septal extension (CSE) graft is a common method used to alter tip projection, alar-columellar relationship, and nasolabial angle.5 However, it can be difficult to stabilize and straighten the CSE graft, especially when performed through an endonasal approach. Use of a polydioxanone plate would provide a scaffolding for the CSE graft and could allow for a technically easier and more predictable surgical procedure.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000', 'lowerLimit': '23', 'upperLimit': '64'}, {'value': '48', 'groupId': 'BG001', 'lowerLimit': '29', 'upperLimit': '62'}, {'value': '48.5', 'groupId': 'BG002', 'lowerLimit': '23', 'upperLimit': '64'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2015-01-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-12', 'studyFirstSubmitDate': '2010-10-19', 'resultsFirstSubmitDate': '2020-08-11', 'studyFirstSubmitQcDate': '2010-10-19', 'lastUpdatePostDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-12', 'studyFirstPostDateStruct': {'date': '2010-10-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-01-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Live Assessment of Satisfaction With the Grafts', 'timeFrame': '12 months post operative', 'description': 'Efficacy will be determined by a live assessment of satisfaction with the grafts at 12 months using a four-point categorical satisfaction scale ((4) unsatisfied, (3) satisfied, (2) very satisfied, (1) highly satisfied).\n\nScores closer to 1 indicate a more favorable outcome'}, {'measure': 'Assessment of Tip Projection', 'timeFrame': '12 months Post opeartive', 'description': "Tip projection will be measured using standardized photography preoperatively and at 1 month, 3 months, 6 months, and 12 months postoperatively using Goode's Ratio.\n\nThe ratio of the line from the alar crease to the nasal tip to the nasion to the nasal tip should be 0.55. If it is more than that the nose is over projected, if it is under that ratio the nose is under projected."}, {'measure': 'Non-treating Blinded Evaluator Satisfaction Assessment', 'timeFrame': 'Assessed at baseline, 1 month, 3 months, 6 months, and 12 months; Month 12 reported', 'description': "A non-treating blinded evaluator will assess satisfaction with a four-point categorical satisfaction scale ((4) - unsatisfied, (3) - satisfied, (2) - very satisfied, (1) - highly satisfied) of subject's grafts using photographs from baseline, 1 month, 3 months, 6 months, and 12 months and will consist of a blinded evaluation in which the physician is aware of the type of graft, but unaware of plating status or the specific grafting site.\n\nScores closer to 1 indicate a more favorable outcome"}, {'measure': 'Ease of Use', 'timeFrame': '1 hour following surgery', 'description': 'Ease of use will be determined by the treating investigator using a 10 cm Visual Analog Scale (VAS) to demonstrate technical ease with a score of 0 mm being easy and a scale of 100 mm being extremely difficult.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Infection, Rejection, and Extrusion of the Graft at 1 Week, 1 Month, 3 Months, 6 Months, and 12 Months', 'timeFrame': '12 months post surgery', 'description': 'Safety will be determined by rate of infection, rejection, and extrusion of the graft at 1 week, 1 month, 3 months, 6 months, and 12 months.'}, {'measure': 'Intraoperative Duration', 'timeFrame': 'During surgery (up to 3 hours)', 'description': 'The intraoperative duration of the grafting procedure will be measured by an assistant using a stopwatch to record the time it takes to harvest, shape, and satisfactorily secure the graft.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Caudal septal extension graft', 'Primary rhinoplasty', 'Secondary rhinoplasty'], 'conditions': ['Rhinoplasty']}, 'referencesModule': {'references': [{'pmid': '26501937', 'type': 'DERIVED', 'citation': 'Dayan SH, Ashourian N. Polydioxanone Absorbable Plate for Cartilaginous Grafting in Endonasal Rhinoplasty: A Randomized Clinical Trial. JAMA Facial Plast Surg. 2016 Jan-Feb;18(1):47-53. doi: 10.1001/jamafacial.2015.1492.'}], 'seeAlsoLinks': [{'url': 'http://www.denovaresearch.com', 'label': 'DeNova Research'}, {'url': 'http://www.drdayan.com', 'label': 'Dr. Steven H. Dayan, MD FACS'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine efficacy, safety, and ease of cartilaginous grafting using polydioxanone (PDS) plates in comparison to non-plated cartilaginous grafts as performed through an endonasal rhinoplasty approach in patients requiring a caudal septal extension (CSE) graft.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Males and females between 18 and 65 years of age.\n* Subjects requesting primary or secondary rhinoplasty and requiring a CSE graft performed through an endonasal approach.\n* Subjects willing to undergo PDS plating.\n* Subjects with either ear conchal or septal cartilage available for grafting purposes.\n* Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.\n* Willingness and ability to comply with the PI's standard preoperative and postoperative rhinoplasty instructions.\n* Subjects of childbearing potential must have a negative urine pregnancy test result at Visit 1 and be willing able to use an acceptable method of birth control (e.g., barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following is documented on the medical history:\n* postmenopausal for at least 12 months prior to study drug administration\n* without a uterus and/or both ovaries\n* has had a bilateral tubal ligation for at least 6 months prior to study drug administration.\n* absence of an other physical condition according to the PI's discretion\n* Willingness and ability to provide written photo consent and adherence to photography procedures (i.e., removal of jewelry and makeup).\n* Willingness and ability to provide written informed consent prior to performance of any study related procedure.\n\nExclusion Criteria:\n\n* Subjects who are pregnant, nursing, planning to become pregnant, and/or not using a reliable form of birth control.\n* Subjects with a significant systemic illness or illness localized to the areas of treatment.\n* Subjects with previous history of nasal implants.\n* Subjects with previous or current history of nasal infections.\n* Subjects who have history of blood thinners (aspirin, ibuprofen, naprosyn, herbal supplements, Vitamin E) within the two weeks prior to surgery.\n* Subjects who have smoked within the two weeks prior to surgery.\n* Subjects who have had alcohol or illicit drugs one week prior to surgery.\n* Subjects who have eaten or drank anything after midnight the night prior to surgery.\n* Subjects with current history of chronic drug or alcohol abuse.\n* History of autoimmune disease.\n* Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study medication.\n* Subjects who anticipate the need for surgery, other than the study procedure, or overnight hospitalization during the study.\n* Subjects who, in the Investigator's opinion, have a history of poor cooperation, non compliance with medical treatment or unreliability.\n* Enrollment in any active study involving the use of investigational devices or drugs."}, 'identificationModule': {'nctId': 'NCT01225250', 'briefTitle': 'Safety and Efficacy Study of Polydioxanone (PDS) Plates in Rhinoplasty', 'organization': {'class': 'OTHER', 'fullName': 'DeNova Research'}, 'officialTitle': 'An Open-Label, Randomized, 2-Arm Parallel Study Comparing the Efficacy, Ease of Use, and Safety of PDS Plated Cartilagenous Grafting Versus Non-Plated Cartilagenous Grafting as Performed Through Endonasal Rhinoplasty', 'orgStudyIdInfo': {'id': 'PDS-END-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Polydioxanone (PDS) plates', 'description': '15 subjects will be randomized to receive a caudal septal extension graft using a PDS plated cartilagenous graft', 'interventionNames': ['Device: Polydioxanone (PDS) plates', 'Procedure: Caudal septal extension graft performed through endonasal rhinoplasty']}, {'type': 'OTHER', 'label': 'Non-plated cartilagenous graft', 'description': '15 subjects will be randomized to receive a cartilagenous caudal septal extension fgraft', 'interventionNames': ['Procedure: Caudal septal extension graft performed through endonasal rhinoplasty']}], 'interventions': [{'name': 'Polydioxanone (PDS) plates', 'type': 'DEVICE', 'description': '0.5 mm PDS Flexible Plate made of poly-p-dioxanone, an aliphatic polyester which is manufactured by polymerization of the monomer p-dioxanone. Polydioxanone is a resorbable material degraded by hydrolysis and has been successfully used for bone discontinuities and septal reconstruction.', 'armGroupLabels': ['Polydioxanone (PDS) plates']}, {'name': 'Caudal septal extension graft performed through endonasal rhinoplasty', 'type': 'PROCEDURE', 'description': 'The caudal septal extension (CSE) graft is a common method used to alter tip projection, alar-columellar relationship, and nasolabial angle.5 However, it can be difficult to stabilize and straighten the CSE graft, especially when performed through an endonasal approach. Use of a polydioxanone plate would provide a scaffolding for the CSE graft and could allow for a technically easier and more predictable surgical procedure.', 'armGroupLabels': ['Polydioxanone (PDS) plates']}, {'name': 'Caudal septal extension graft performed through endonasal rhinoplasty', 'type': 'PROCEDURE', 'description': 'The caudal septal extension (CSE) graft is a common method used to alter tip projection, alar-columellar relationship, and nasolabial angle.5 However, it can be difficult to stabilize and straighten the CSE graft, especially when performed through an endonasal approach. Use of a polydioxanone plate would provide a scaffolding for the CSE graft and could allow for a technically easier and more predictable surgical procedure.', 'armGroupLabels': ['Non-plated cartilagenous graft']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'DeNova Research', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Steven H Dayan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'DeNova Research/ Chicago Center for Facial Plastic Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DeNova Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mentor Worldwide, LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Director', 'investigatorFullName': 'Steven H. Dayan', 'investigatorAffiliation': 'DeNova Research'}}}}