Botox in the Healing of Surgical Wounds of the Neck

NCT01177358 | Completed Phase 2

• 1 other identifier: BTX-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators hypothesize that Botox A will reduce scarring and improve healing of surgical neck wounds.

Conditions

Scar

Keywords

Scar; Botox

Outcome Measures

Primary Outcomes (1)

• Vancouver Scar Scale

  The surgeon will assess the healing of the surgical incision at 6 months and fill out the Vancouver Scar Scale following the operation.

  6 months

Secondary Outcomes (3)

• Patient and Observer Scar Assessment Scale

  4 weeks

• Patient and Observer Scar Assessment Scale

  6 months

• Vancouver Scar Scale

  4 weeks

Study Arms (2)

Botulinum Toxin A injection

EXPERIMENTAL

A vial of Botulinum Toxin A containing 100U of Botox will be reconstituted with 2mL of normal saline for a concentration of 50U/mL. 5 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.

Drug: Botulinum Toxin Type A

Saline

PLACEBO COMPARATOR

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.

Drug: Normal Saline

Interventions

Botulinum Toxin Type A DRUG

A vial of Botulinum Toxin A containing 100U of Botox will be reconstituted with 2mL of normal saline for a concentration of 50U/mL. 5 units (0.1mL) of Botulinum Toxin a will be injected at midline and 1.5cm lateral to midline, bidirectionally, following a thyroidectomy or parathyroidectomy.

Also known as: Allergan Botox, Drug Identification Number 01981501

Botulinum Toxin A injection

Normal Saline DRUG

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.

Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all patients referred to the ENT clinic for a thyroidectomy or parathyroidectomy

You may not qualify if:

• patients with missing information, including demographic information
• patients lost to follow up or have been followed for less than 6 months
• patients with known allergy to lidocaine
• patients in whom botox would be contraindicated in:
• known history of neuromuscular disorders (myasthenia gravis, amyotrophic lateral sclerosis, Eaton-Lambert syndrome)
• pregnant women
• known allergy to botox, albumin

Sponsors & Collaborators

• Nova Scotia Health Authority: lead
• Allergan: collaborator

Study Sites (1)

Queen Elizabeth II Hospital

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Related Publications (5)

• 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: 19289689 RESULT

• 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: 16901024 RESULT

• 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: 16651948 RESULT

• 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: 19357910 RESULT

• 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.

  PMID: 30688903 DERIVED

MeSH Terms

Conditions

Cicatrix

Interventions

Botulinum Toxins, Type A; Saline Solution

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Mark Taylor, FRCS

  Capital District Health Authority Nova Scotia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2010
• First Posted: August 9, 2010
• Study Start: May 31, 2010
• Primary Completion: May 5, 2016
• Study Completion: May 5, 2016
• Last Updated: August 21, 2024

Record last verified: 2022-10

Locations

CA (1)