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临床试验/NCT01177358
NCT01177358已完成2 期

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

Nova Scotia Health Authority1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2010年5月31日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
40
试验地点
1
主要终点
Vancouver Scar Scale

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Botulinum Toxin Type A (Drug)

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.

干预措施: Normal Saline (Drug)

结局指标

主要结局

Vancouver Scar Scale

时间窗: 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.

次要结局

  • Patient and Observer Scar Assessment Scale(6 months)
  • Vancouver Scar Scale(4 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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