Clinical trial NCT01177358: Botox in the Healing of Surgical Wounds of the Neck
Official title: Botulinum Toxin A in the Healing of Surgical Wounds of the Neck: a Randomized, Prospective, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Scar
Keywords: Scar
Botox
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2010-08-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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 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

Primary outcomes:
measure: Vancouver Scar Scale
timeFrame: 6 months
Secondary outcomes:
measure: Patient and Observer Scar Assessment Scale
timeFrame: 4 weeks
measure: Patient and Observer Scar Assessment Scale
timeFrame: 6 months
measure: Vancouver Scar Scale
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Queen Elizabeth II Hospital
state: Nova Scotia
Study officials:
affiliation: Capital District Health Authority Nova Scotia
name: Mark Taylor, FRCS
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.