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OpenTrials
Completed

NCT Number: NCT01177358

Botox in the Healing of Surgical Wounds of the Neck

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Queen Elizabeth II Hospital

Halifax, Nova Scotia, B3H 1V7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Allergan Botox, Drug Identification Number 01981501

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.

Primary outcomes

  1. Vancouver Scar Scale

    Time frame: 6 months

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

Secondary outcomes

  1. Patient and Observer Scar Assessment Scale

    Time frame: 4 weeks

    The surgeon and the patient will be asked to fill out the survey at 4 weeks following the operation.

  2. Patient and Observer Scar Assessment Scale

    Time frame: 6 months

    The surgeon and the patient will be asked to fill out the survey at 6 months following the operation.

  3. Vancouver Scar Scale

    Time frame: 4 weeks

    The surgeon will assess the healing of the surgical incision and fill out the Vancouver Scar Scale at 4 weeks following the operation.

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Collaborators

  • Allergan

Registry information

Official study title

Botulinum Toxin A in the Healing of Surgical Wounds of the Neck: a Randomized, Prospective, Placebo-controlled Trial

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Aug 9, 2010
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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