Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2025-12-25 @ 10:08 PM
Study NCT ID:
NCT01177358
Status:
COMPLETED
Last Update Posted:
2024-08-21
First Post:
2010-07-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Botox in the Healing of Surgical Wounds of the Neck
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002921', 'term': 'Cicatrix'}], 'ancestors': [{'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2016-05-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-19', 'studyFirstSubmitDate': '2010-07-08', 'studyFirstSubmitQcDate': '2010-08-06', 'lastUpdatePostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vancouver Scar Scale', 'timeFrame': '6 months', 'description': 'The surgeon will assess the healing of the surgical incision at 6 months and fill out the Vancouver Scar Scale following the operation.'}], 'secondaryOutcomes': [{'measure': 'Patient and Observer Scar Assessment Scale', 'timeFrame': '4 weeks', 'description': 'The surgeon and the patient will be asked to fill out the survey at 4 weeks following the operation.'}, {'measure': 'Patient and Observer Scar Assessment Scale', 'timeFrame': '6 months', 'description': 'The surgeon and the patient will be asked to fill out the survey at 6 months following the operation.'}, {'measure': 'Vancouver Scar Scale', 'timeFrame': '4 weeks', 'description': 'The surgeon will assess the healing of the surgical incision and fill out the Vancouver Scar Scale at 4 weeks following the operation.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Scar', 'Botox'], 'conditions': ['Scar']}, 'referencesModule': {'references': [{'pmid': '19289689', 'type': 'RESULT', 'citation': 'Gassner HG, Sherris DA, Friedman O. Botulinum toxin-induced immobilization of lower facial wounds. Arch Facial Plast Surg. 2009 Mar-Apr;11(2):140-2. doi: 10.1001/archfacial.2009.3. No abstract available.'}, {'pmid': '16901024', 'type': 'RESULT', 'citation': 'Gassner HG, Brissett AE, Otley CC, Boahene DK, Boggust AJ, Weaver AL, Sherris DA. Botulinum toxin to improve facial wound healing: A prospective, blinded, placebo-controlled study. Mayo Clin Proc. 2006 Aug;81(8):1023-8. doi: 10.4065/81.8.1023.'}, {'pmid': '16651948', 'type': 'RESULT', 'citation': 'Wilson AM. Use of botulinum toxin type A to prevent widening of facial scars. Plast Reconstr Surg. 2006 May;117(6):1758-66; discussion 1767-8. doi: 10.1097/01.prs.0000209944.45949.d1.'}, {'pmid': '19357910', 'type': 'RESULT', 'citation': 'Xiao Z, Zhang F, Cui Z. Treatment of hypertrophic scars with intralesional botulinum toxin type A injections: a preliminary report. Aesthetic Plast Surg. 2009 May;33(3):409-12. doi: 10.1007/s00266-009-9334-z. Epub 2009 Apr 9.'}, {'pmid': '30688903', 'type': 'DERIVED', 'citation': 'Phillips TJ, Fung E, Rigby MH, Burke E, Hart RD, Trites JRB, Gassner HG, Taylor SM. The Use of Botulinum Toxin Type A in the Healing of Thyroidectomy Wounds: A Randomized, Prospective, Placebo-Controlled Study. Plast Reconstr Surg. 2019 Feb;143(2):375e-381e. doi: 10.1097/PRS.0000000000005264.'}]}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that Botox A will reduce scarring and improve healing of surgical neck wounds.', 'detailedDescription': 'Botulinum Toxin A is a toxin produced by the anaerobic bacterial species Clostridium botulinum. The toxin specifically inhibits release of the neurotransmitter Acetylcholine at synaptic junctions, thus preventing neuromuscular transmission, and inducing paralysis of the muscle.\n\nPrevious studies have indicated that tensile forces on the skin may affect the healing of a wound. These forces act against the immature collagen laid down during wound healing and may stimulate overgrowth, thereby contributing to the formation of hypertrophic scars or keloids.\n\nUsing botox to paralyse the underlying muscles may reduce the tensile force on the overlying skin, and thus reduce scar formation and promote healing. Botox has also been shown to affect the cell cycle distribution of fibroblasts derived from hypertrophic scars.\n\nThe objective of this study is to determine the effects of BTX-A in wound healing and the reduction of scar formation.\n\nPatients undergoing a thyroidectomy or parathyroidectomy will be randomized to receive either BTX-A injections along the surgical site or placebo immediately following closure. All incisions will be sutured in a similar fashion. BTX-A or normal saline will then be injected along the platysma muscle. The patient and the surgeon will be blinded to the treatment arm. Photographs will be taken of the surgical site at 4 weeks and 6 months. The patient and two otolaryngologists will independently score the healing of the wound using a standardized scoring method. The scores be compared between the two surgeons to determine correspondence and interobserver reliability.\n\nThe scores of the two treatment arms will be compared to reveal the effect of BTX-A on wound healing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patients referred to the ENT clinic for a thyroidectomy or parathyroidectomy\n\nExclusion Criteria:\n\n* patients with missing information, including demographic information\n* patients lost to follow up or have been followed for less than 6 months\n* patients with known allergy to lidocaine\n* patients in whom botox would be contraindicated in:\n* known history of neuromuscular disorders (myasthenia gravis, amyotrophic lateral sclerosis, Eaton-Lambert syndrome)\n* pregnant women\n* known allergy to botox, albumin'}, 'identificationModule': {'nctId': 'NCT01177358', 'briefTitle': 'Botox in the Healing of Surgical Wounds of the Neck', 'organization': {'class': 'OTHER', 'fullName': 'Nova Scotia Health Authority'}, 'officialTitle': 'Botulinum Toxin A in the Healing of Surgical Wounds of the Neck: a Randomized, Prospective, Placebo-controlled Trial', 'orgStudyIdInfo': {'id': 'BTX-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Botulinum Toxin A injection', 'description': 'A vial of Botulinum Toxin A containing 100U of Botox will be reconstituted with 2mL of normal saline for a concentration of 50U/mL.\n\n5 Units (0.1 mL) of Botulinum Toxin A will be injected at three sites along the incision (midline and 1.5 cm lateral to midline) following a thyroidectomy or parathyroidectomy.', 'interventionNames': ['Drug: Botulinum Toxin Type A']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline', 'description': '0.1 mL of normal saline in a placebo vial containing 2 mL of normal saline will be injected along the incision (midline and 1.5 cm lateral to midline) following a thyroidectomy or parathyroidectomy.', 'interventionNames': ['Drug: Normal Saline']}], 'interventions': [{'name': 'Botulinum Toxin Type A', 'type': 'DRUG', 'otherNames': ['Allergan Botox', 'Drug Identification Number 01981501'], 'description': 'A vial of Botulinum Toxin A containing 100U of Botox will be reconstituted with 2mL of normal saline for a concentration of 50U/mL.\n\n5 units (0.1mL) of Botulinum Toxin a will be injected at midline and 1.5cm lateral to midline, bidirectionally, following a thyroidectomy or parathyroidectomy.', 'armGroupLabels': ['Botulinum Toxin A injection']}, {'name': 'Normal Saline', 'type': 'DRUG', 'description': '0.1mL of normal saline in a placebo vial containing 2mL of normal saline will be injected along three sites (midline and 1.5cm lateral from midline) following a thyroidectomy or parathyroidectomy.', 'armGroupLabels': ['Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B3H 1V7', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Queen Elizabeth II Hospital', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}], 'overallOfficials': [{'name': 'Mark Taylor, FRCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Capital District Health Authority Nova Scotia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nova Scotia Health Authority', 'class': 'OTHER'}, 'collaborators': [{'name': 'Allergan', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}