Obsidian® RFT
regenerative fistula treatment
Obsidian RFT
Obsidian® RFT is an autologous, platelet rich bioactive matrix for regenerative treatment of fistulas providing a sphincter-sparing minimally invasive procedure. Obsidian® RFT can close and heal fistulas and can be co-delivered with antibiotics embedded in Obsidian® RFT.1-3
Common techniques in fistula surgery can be performed in combination with Obsidian® RFT.4
Obsidian® RFT is an autologous, platelet rich bioactive matrix with prolonged release of non-activated platelets which, upon contact with tissue, release growth factors over a period of 5-7 days improving tissue regeneration and healing of fistulas. The special fistula brush included in the Obsidian® RFT set makes it easy to prepare the fistula tract prior to application. Filling the fistula tract with Obsidian® RFT accelerates tissue proliferation to support healing and through the anti-inflammatory and antimicrobial platelet properties it may offer control of potential contamination. Obsidian® RFT is completely absorbable. With the use of the Vivostat® Co-Delivery system, Obsidian® RFT can be co-applied with antibiotics, embedded in the platelet rich bioactive matrix.
benefits of obsidian® rft
- Regenerative fistula treatment
- Effectively closes and heals fistulas1-3
- Provides a sphincter-sparing minimally invasive procedure1-3
- Can be co-delivered with antibiotics embedded in the bioactive platelet rich sealant
Obsidian® RFT surgical procedure
PART 1: Preparation of the fistula tract
Seton should be in place 4-6 weeks before surgical procedure
Seton should be in place 4-6 weeks before surgical procedure
- Expose the fistula tract(s)
- Insert fistula brush. Clean and debride fistula tract(s) with a back-and-forth motion (x20) removing non-vascularized tissue
- Flush fistula tract(s) with saline solution (37°C)
- Repeat debridement and rinsing cycle (steps 2 and 3) as needed.
Important: Thoroughly clean the fistula brush between debridements. - Apply a Z-suture or optionally a mucosal flap
- Perform Cava Test to check the rigidity and resistance of the internal os suture.
Procedure:
- Apply a Z-suture
- Tighten the suture without completely closing it
- Irrigate the area by applying a saline solution from the outer os with proper pressure
- Make sure no fluid leaks from the inner os and the suture is tight enough
- Loosen Z-suture and insert applicator device to apply Obsidian® RFT (see PART 2).
- Insert the Obsidian® RFT endoscopic catheter from the distal outer opening of the fistula to the intraluminal proximal inner fistula ostium
- Apply Obsidian® RFT constantly while slowly retracting the catheter using the application setting “Jet No Air”. Optionally, a second substance of 1-5 ml can be co-delivered with Obsidian® RFT (e.g. antibiotics).
- Close the inner fistula opening via suture or via mucosa flap
- Optionally inject the remaining Obsidian® RFT around the inner ostium of the fistula
- The external fistula ostium remains open
- Cover with non-adherent wound dressing
Obsidian® RFT is an autologous, platelet rich bioactive matrix with prolonged release of non-activated platelets which, upon contact with tissue, release growth factors over a period of 5-7 days improving tissue regeneration and healing of fistulas. The special fistula brush included in the Obsidian® RFT set makes it easy to prepare the fistula tract prior to application. Filling the fistula tract with Obsidian® RFT accelerates tissue proliferation to support healing and through the anti-inflammatory and antimicrobial platelet properties it may offer control of potential contamination. Obsidian® RFT is completely absorbable. With the use of the Vivostat® Co-Delivery system, Obsidian® RFT can be co-applied with antibiotics, embedded in the platelet rich bioactive matrix.
Treatment with Obsidian® RFT may be repeated for complete healing of fistula(s)
Obsidian® RFT for anal fistula treatment:
Extrasphincteric, suprasphincteric, transsphincteric and intersphincteric fistulas.
Special fistula brush included in the Obsidian® RFT Set
Play Video
obsidian® RFT
Click on the video and see perianal fistula treated with Vivostat® PRF – Obsidian® RFT are even better suited for perianal fistulas and comes with a fistular brush included in the set.
PRODUCT order codes obsidian® rft
GM 740
PRO 800
APL 400
APL 404
VS 222
VS 510
GM 740
Obsidian® RFT Set (Fistula brush included)
Application to be controlled with VS 222.
Contact your local distributor for more details.
PRO 800
Processor Unit
Needed to prepare the product.
Contact your local distributor for more details.
APL 400
Applicator Unit
Needed to apply the product.
Contact your local distributor for more details.
APL 404
Applicator Unit – Co-Delivery
Needed to apply co-deliver other substances with the product.
Contact your local distributor for more details.
VS 222
Foot Switch
To be used with APL 400/404.
Contact your local distributor for more details.
VS 510
Vivostat® Split Kit
To be used if you need to freeze the sealant/matrix solution with the intention to treat the patient more than one time from one blood donation.
Contact your local distributor for more details.
Application devices
The Vivostat® System offers a variety of different disposable application devices as well as a number of reusable handles.
General surgery
The ability to use the Vivostat® Endoscopic Applicator in general surgery has proven very useful.
- Lara, F. J. P., Serrano, A. M., Moreno, J., Carmona, J. H., Márquez, M., Perez, L., Del Rey Moreno, A., & Muñoz, H. O. (2014). Platelet-rich fibrin sealant as a treatment for complex perianal fistulas: a multicentre study. Journal of Gastrointestinal Surgery, 19(2), 360–368. https://doi.org/10.1007/s11605-014-2698-7
- Lara, F. J. P., Serrano, A. M., Moreno, J., Carmona, J. H., Márquez, M., Perez, L., Del Rey Moreno, A., & Muñoz, H. O. (2014). Platelet-rich fibrin sealant as a treatment for complex perianal fistulas: a multicentre study. Journal of Gastrointestinal Surgery, 19(2), 360–368. https://doi.org/10.1007/s11605-014-2698-7
- Moreno-Serrano, A., García-Díaz, J. J., Ferrer-Márquez, M., Alarcón, R., Álvarez-García, A., & Reina-Duarte, Á. (2016), Using autologous platelet-rich plasma for the treatment of complex fistulas, Revista Espanola de Enfermedades Digestivas, 108(3), 123-8, https://doi.org/10.17235/reed.2016.3946/2015
- Lara, F. J. P., González, J. M. S., Arjona, T. P., Donoso, F., & Fernández, J. D. (2022), A new, conservative treatment for perianal fistula that may halve the need for surgical intervention – case series, Surgical Innovation, 29(1), 50–55, https://doi.org/10.1177/15533506211015196
- García-Olmo, D., Gómez-Barrera, M., & De La Portilla, F. (2023). Surgical management of complex perianal fistula revisited in a systematic review: a critical view of available scientific evidence. BMC Surgery, 23(1). https://doi.org/10.1186/s12893-023-01912-z
