Botox in the Healing of Surgical Wounds of the Neck

  • STATUS
    Recruiting
  • participants needed
    100
  • sponsor
    Nova Scotia Health Authority
Updated on 22 January 2022
surgical wound
botulinum toxin
scarring
botulinum toxin type a
botox

Summary

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

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.

Details
Condition Scar
Treatment Normal saline, Botulinum Toxin Type A
Clinical Study IdentifierNCT01177358
SponsorNova Scotia Health Authority
Last Modified on22 January 2022

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