The introduction during the last decades of new surgical procedures, new devices and new implants, has sometimes resulted in significant morbidity that could have been prevented if effective preclinical trials were conducted.
PFFSA has a strong collaboration with a university facility that is specialized to perform research. The facility is approved to perform surgery, and PFFSA has their own operating room at this facility, which is about 14 km outside of Stellenbosch.
PFFSA has extensive experience with research studies, and is keen to use this knowledge for additional projects , in any field. Surgeons in South Africa are extremely well trained, and have a high case-load, meaning that they perform more surgery than the average surgeons worldwide. As a result, the clinical evaluation of innovative surgical procedures and new devices, is well placed in South Africa.
PFFSA has performed clinical studies in the field of urogynaecology, but has the infrastructure and ambition to also organize clinical studies in other fields of surgery.
Previous Preclinical Research
A study was performed to evaluate interventions for the treatment of vaginal atrophy. The participants were ovariectomized, in order to induce menopause and create vaginal atrophy. After that half were treated with vaginal laser, and the other half with vaginal estrogens.
Another study was performed to test P4HB as alternative for PP for vaginal prolapse surgery. Half of the study patients will be followed up for 1 year and the other for 2 years.
The results of this study are currently being analyzed.
Ongoing Preclinical Research
In October 2021 we began our research to test a new intervention for Obstetric fistula repair. The main aim of this study is to validate the ovine model for vesicovaginal fistula repair and demonstrate the safety and efficacy of fistula repair with the use of a tissue-engineered solution.