Botox in the Healing of Surgical Wounds of the Neck

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2010 by Capital District Health Authority, Canada
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT01177358
First received: July 8, 2010
Last updated: September 15, 2014
Last verified: August 2010
  Purpose

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


Condition Intervention Phase
Scar
Drug: Botulinum Toxin Type A
Drug: Normal Saline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Botulinum Toxin A in the Healing of Surgical Wounds of the Neck: a Randomized, Prospective, Placebo-controlled Trial

Resource links provided by NLM:


Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • Vancouver Scar Scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The surgeon will assess the healing of the surgical incision at 6 months and fill out the Vancouver Scar Scale following the operation.


Secondary Outcome Measures:
  • Patient and Observer Scar Assessment Scale [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The surgeon and the patient will be asked to fill out the survey at 4 weeks following the operation.

  • Patient and Observer Scar Assessment Scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The surgeon and the patient will be asked to fill out the survey at 6 months following the operation.

  • Vancouver Scar Scale [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The surgeon will assess the healing of the surgical incision and fill out the Vancouver Scar Scale at 4 weeks following the operation.


Estimated Enrollment: 100
Study Start Date: September 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Botulinum Toxin A injection

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

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.

Other Names:
  • Allergan Botox
  • Drug Identification Number 01981501
Placebo Comparator: Saline
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
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.

Detailed Description:

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.

Previous 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.

Using 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.

The objective of this study is to determine the effects of BTX-A in wound healing and the reduction of scar formation.

Patients 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.

The scores of the two treatment arms will be compared to reveal the effect of BTX-A on wound healing.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01177358

Contacts
Contact: Elaine W Fung, BSc, MD 1-902-412-1240 elaine.fung@dal.ca

Locations
Canada, Nova Scotia
Queen Elizabeth II Hospital Recruiting
Halifax, Nova Scotia, Canada, B3H 1V7
Contact: Elaine W Fung, MD, BSc    1-902-412-1240    elaine.fung@dal.ca   
Principal Investigator: Mark Taylor, FRCS         
Sponsors and Collaborators
Capital District Health Authority, Canada
Allergan
Investigators
Principal Investigator: Mark Taylor, FRCS Capital District Health Authority Nova Scotia
  More Information

Publications:
Responsible Party: Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT01177358     History of Changes
Other Study ID Numbers: BTX-001
Study First Received: July 8, 2010
Last Updated: September 15, 2014
Health Authority: Canada: Health Canada

Keywords provided by Capital District Health Authority, Canada:
Scar
Botox

Additional relevant MeSH terms:
Botulinum Toxins
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014