At a glance
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A Randomized, Placebo-Controlled, Double-Blind, Prospective Clinical Trial of Botulinum Toxin Type A in Prevention of Hypertrophic Scar Development in Median Sternotomy Wound
In Brief
A Phase 3 clinical trial evaluating Botulinum toxin type A and normal saline for Scar. Completed, enrolled 17 participants across 1 site.
Detailed Summary
Linear hypertrophic scar is a common surgical problem that can be difficult to manage, especially for the median sternotomy scar. Despite high demand for the early intervention to prevent and treat surgical scars, there is yet no universal consensus on satisfactory treatment. Botulinum toxin type A is a neurotoxin that has been widely and safely used in medicine for more than 30 years. It induces chemodenervation through acting on the presynaptic neuron to prevent release of acetylcholine, which leads to functional denervation of striated muscle for about 6 months after injection. The aim of this randomized controlled trial is to evaluate the efficacy of Botulinum toxin type A as a prophylactic treatment in the early postoperative of median sternotomy for the purpose of preventing excess scar formation.
Study Details
Timeline
Interventions
50 units of botulinum toxin diluted in 1 ml of normal saline will be administered. 0.1mlof BTA will be injected with a 30G needle.
0.1mlof normal saline will be injected with a 30G needle.