Most analgesic programs require an experiment that demonstrates drug efficacy in soft tissue surgery.
While the bunionectomy is the gold standard for acute pain experiments in boney surgery, for many years there was no soft tissue equivalent to a bunionectomy (a rapidly recruiting reliable, experimental soft tissue model with good assay sensitivity). Mindful of this experimental gap and market need, Lotus Clinical Research developed and validated the abdominoplasty model after years of study and pilot work.
For abdominoplasty trials, Lotus Clinical Research provides full CRO service with access to our ERG affiliated sites specialized in these trials. Not only can we perform single-center abdominoplasty studies within our own walls, but we also utilize a network of four well-vetted sites throughout the country for multicenter investigations.
The key to success in abdominoplasty research is minimization of variability and placebo response. To accomplish this, our CRO utilizes the Lotus Clinical Research subject placebo response education toolkit. This toolkit has been successfully deployed when our organization serves as a single abdominoplasty center and/or in multicenter abdominoplasty trials in which Lotus Clinical Research serves as the CRO.
The abdominoplasty model has attributes that make it a superior choice to other soft tissue models (such as laparoscopic cholecystectomy, hysterectomy, and herniorrhaphy), namely:
- Rapid, reliable enrollment guided by advertisement.
- A significant surgical insult which results in adequate pain trajectory against which experimental agents can demonstrate assay sensitivity. Smaller soft tissue surgeries, such as laparoscopic cholecystectomy, have a minimal pain signature and, as such, poor assay sensitivity.
- Variability reduction secondary to a standardized anesthetic regimen and surgical technique.
