NCT06798935

Feasibility and Safety of Additional Injection of Autologous Platelet-rich Stroma to Surgical Treatment of Rectovaginal Fistulas

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Erasmus Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Is the addition of platelet-rich stroma (PRS) injection, a form of autologous call therapy, to surgical treatment for rectovaginal fistula feasible and safe? The primary endpoints of this study are feasibility and safety until 12 months after surgery. Secondary endpoints include rates of clinical and radiological closure, recurrence rates after clinical or radiological closure and unplanned re-interventions within 12-month post-surgery.

Conditions

• Rectovaginal Fistula
• Anovaginal Fistula

Interventions

Type	Name	Description
PROCEDURE	autologous platelet-rich stroma	Autologous platelet-rich stroma, which is the combined product of stromal vascular fraction and platelet-rich plasma

Timeline

• Start date: 2019-01-11
• Primary completion: 2024-09-04
• Completion: 2024-09-04
• First posted: 2025-01-29
• Last updated: 2025-01-29

Locations

1 site across 1 country: Netherlands