Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06430931
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-02
Brief Title:
Biological OviTex Versus Synthetic Graft in Robotic Prolapse Surgery
Sponsor:
Meander Medical Center
Organization:
Meander Medical Center
Study Overview
Official Title:
Biological OviTex Versus Synthetic Graft in Robotic Prolapse Surgery a Multicentre Phase 11-111 Partially Randomised Patient Preference Trial
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ProTex
Brief Summary:
This prospective study aims to assess the efficacy of the OviTex 1S permanent mesh in pelvic floor surgery in comparison with the current standard polypropylene mesh
Detailed Description:
Minimal-invasive ventral mesh rectopexy VMR and sacrocolporectopexy SCR or cervicopexy are widely accepted treatments for patients suffering from pelvic prolapse Choice of material used in VMR or SCRP - synthetic or biologic surgical mesh - remains subject of debate Recent ban in the usage of non abdominal but transvaginal mesh for pelvic organ prolapse POP in April 2019 by the Food and Drug Administration FDA has negatively influenced the perception on all sorts of surgical mesh Currently the most widely used mesh in VMR is synthetic and has shown good results regarding recurrence mesh exposure and functional outcome Although complication rates are low the serious complications of fistulation exposition and dyspareunia are reasons to opt for a more expensive biological mesh High-quality evidence of synthetic versus biological mesh is lacking which does not stop resistance against synthetic mesh from growing This has even led to concerns and questions about synthetic mesh use from the Dutch government addressed at the medical professionals and options for alternatives are being asked
Biological grafts are characterized by degradation of the implant and regeneration of host tissue It is assumed that this process of degradation and remodeling decreases the risk of exposition and infection However this transformation may possibly lead to a higher chance of recurrence in the long term Rate of recurrence but also graft-related complications GRC to a lesser extent largely depends on duration of follow-up Since biological graft implementation in VMR and SCR is relatively new and its usage is restricted due to higher costs evidence on biological mesh with long term follow-up is limited In addition there is a significant difference in various described biological meshes This is important to keep in mind when comparing outcome of VMR or SCR with synthetic versus biologic mesh
In VMR there are no randomised controlled trials on synthetic versus biological mesh The biological meshes studied thus far are Biodesign and Permacol Mesh exposure rates after VMR with Biodesign and Permacol have both been studied in three studies in total N 349 and N 425 in total respectively and show low mesh exposure rates of 0 to 01 In comparison GRC after VMR with synthetic non-resorbable mesh like polypropylene are around 2 Recurrence rates after synthetic mesh in VMR range between 2 and 14 after a median follow-up of 12-61 months When comparing studies on biologic implants that report on recurrence rates there seems to be a slight difference in favor of Biodesign Studies on Biodesign in VMR with a median follow-up ranging between 12 and 47 months show a recurrence rate around 5 Literature on Permacol shows higher recurrence rates ranging between 5 to 14 after a median follow-up of 12 to 29 months
In sacrocolpopexy SCP allografts and xenografts have been investigated as an alternative for polypropylene A randomised controlled trial compared SCP using polypropylene mesh with solvent cadaveric fascia lata After one year of follow-up polypropylene mesh had a higher anatomical cure rate than cadaveric fascia lata 91 percent versus 68 percent p0007 Two GRC occurred in patients who received polypropylene mesh while none occurred in the allograft group p 05 Another RCT with the same comparison and a follow-up of 5 years showed similar results with considering cadaveric fascia not as strong of a support Deprest et al compared polypropylene mesh with porcine grafts in a prospective study and found xenografts to be associated with more apical failures and reoperations than with a polypropylene mesh 21 percent versus 3 percent p 001However there was no significant difference in functional outcomes between the two groups An exposure rate of 11 percent was described in both groups A more recent study concluded by analyzing clinical outcomes and patients satisfaction that a non-crosslinked ADM patch can be a good alternative to synthetic polypropylene mesh in patients undergoing SCP
Although Biodesign Surgisis Permacol and other are all grouped under the common denominator Biologic mesh each of these products is unique There are differences in tissue source differences in the processes used to decellularize the tissue and differences in the final processing steps such as sterilization and preservation As a result there are significant variations in biological and clinical performance between these products Permacol which is purposely cross-linked pig dermis behaves like a synthetic material in-vivo and induces a permanent foreign body response leading to encapsulation This prevents integration with and in the surrounding tissue Consequently high rates of mesh exposure occur with Permacol implants Biodesign one of the early biologics is derived from small intestinal submucosa and is a non-cross-linked mesh Likely due to its proprietary processing Biodesign in practice often dissolves before healing and remodeling can take place
A novelty on the surgical mesh market is OviTex It is produced by Aroa Biosurgery and consist of sterile sheep extracellular matrix ECM interwoven with a absorbable or non-absorbable synthetic fiber OviTex comes with a grid of absorbable polyglycolic acid PGA or permanent polypropylene and with differing amounts of layers Core 1S and 2S Unique to OviTex is its composition which consists of essential components required for regeneration of host tissue Additionally the coupling of an ECM with a absorbable synthetic fiber provide strength without the need to cross-link the ECM Moreover OviTex is lower in costs than any other biological mesh on the market Since the use of synthetic meshes in pelvic floor surgery has come under scrutiny patients are tempted to undergo a resection rectopexy as an alternative to VMR with polypropylene Apart from the fact that the resection is associated with a higher risk of complications due to the application of an anastomosis the recovery time is much longer The hospitalization period would be longer and therefore the costs compared to prolapse surgery with OviTex would be higher
Preliminary results of a recent pilot study at Meander MC showed that the use of an OviTex PGA with absorbable grid mesh in the pelvic floor is feasible and safe Nevertheless 2 out of 11 patients who completed follow-up of 6 months showed an early anatomical recurrence This suggests that the use of permanent synthetic fiber may be necessary for a more durable repair and fewer recurrences than using OviTex PGA Although resistance against synthetic grafts is growing OviTex Permanent contains 96 sheep ECM and only 4 polymer compared to the standard Prolene mesh which is 100 polymer polymer areal density 16gm2 OviTex 1S vs 76gm2 prolene Furthermore the polymer is embedded in the ECM which further attenuates any inflammatory response Observations in primates show that the minimized amount of embedded synthetic reinforcement results in an implant that histologically behaves like a biologic mesh yet maintains its functional structure This is the first prospective multicenter study using a OviTex 1S mesh Although the material ovine was studies before little is known about the feasibility of enrolling these patients into randomised studies in the Netherlands and about the feasibility safety and tolerance of the OviTex 1s is this setting Therefore the investigators decided to start with a phase II study This allows for adequate monitoring of the feasibility safety and tolerance of the experimental treatment
There are no studies comparing OviTex to the current standard Prolene PMN3 Ethicon Inc Johnson Johnson Amersfoort The Netherlands Therefore a comparative study should be conducted before OviTex is used as a biologic alternative for polypropylene in VMR on a larger scale Following the OviTex pilot study the investigators aim to conduct a follow-up study ProTex trial in which both in the short and longer term the efficacy of the OviTex mesh in pelvic floor surgery will be assessed in comparison with the current standard polypropylene by means of a non-inferiority test
Biological grafts are characterized by degradation of the implant and regeneration of host tissue It is assumed that this process of degradation and remodeling decreases the risk of exposition and infection However this transformation may possibly lead to a higher chance of recurrence in the long term Rate of recurrence but also graft-related complications GRC to a lesser extent largely depends on duration of follow-up Since biological graft implementation in VMR and SCR is relatively new and its usage is restricted due to higher costs evidence on biological mesh with long term follow-up is limited In addition there is a significant difference in various described biological meshes This is important to keep in mind when comparing outcome of VMR or SCR with synthetic versus biologic mesh
In VMR there are no randomised controlled trials on synthetic versus biological mesh The biological meshes studied thus far are Biodesign and Permacol Mesh exposure rates after VMR with Biodesign and Permacol have both been studied in three studies in total N 349 and N 425 in total respectively and show low mesh exposure rates of 0 to 01 In comparison GRC after VMR with synthetic non-resorbable mesh like polypropylene are around 2 Recurrence rates after synthetic mesh in VMR range between 2 and 14 after a median follow-up of 12-61 months When comparing studies on biologic implants that report on recurrence rates there seems to be a slight difference in favor of Biodesign Studies on Biodesign in VMR with a median follow-up ranging between 12 and 47 months show a recurrence rate around 5 Literature on Permacol shows higher recurrence rates ranging between 5 to 14 after a median follow-up of 12 to 29 months
In sacrocolpopexy SCP allografts and xenografts have been investigated as an alternative for polypropylene A randomised controlled trial compared SCP using polypropylene mesh with solvent cadaveric fascia lata After one year of follow-up polypropylene mesh had a higher anatomical cure rate than cadaveric fascia lata 91 percent versus 68 percent p0007 Two GRC occurred in patients who received polypropylene mesh while none occurred in the allograft group p 05 Another RCT with the same comparison and a follow-up of 5 years showed similar results with considering cadaveric fascia not as strong of a support Deprest et al compared polypropylene mesh with porcine grafts in a prospective study and found xenografts to be associated with more apical failures and reoperations than with a polypropylene mesh 21 percent versus 3 percent p 001However there was no significant difference in functional outcomes between the two groups An exposure rate of 11 percent was described in both groups A more recent study concluded by analyzing clinical outcomes and patients satisfaction that a non-crosslinked ADM patch can be a good alternative to synthetic polypropylene mesh in patients undergoing SCP
Although Biodesign Surgisis Permacol and other are all grouped under the common denominator Biologic mesh each of these products is unique There are differences in tissue source differences in the processes used to decellularize the tissue and differences in the final processing steps such as sterilization and preservation As a result there are significant variations in biological and clinical performance between these products Permacol which is purposely cross-linked pig dermis behaves like a synthetic material in-vivo and induces a permanent foreign body response leading to encapsulation This prevents integration with and in the surrounding tissue Consequently high rates of mesh exposure occur with Permacol implants Biodesign one of the early biologics is derived from small intestinal submucosa and is a non-cross-linked mesh Likely due to its proprietary processing Biodesign in practice often dissolves before healing and remodeling can take place
A novelty on the surgical mesh market is OviTex It is produced by Aroa Biosurgery and consist of sterile sheep extracellular matrix ECM interwoven with a absorbable or non-absorbable synthetic fiber OviTex comes with a grid of absorbable polyglycolic acid PGA or permanent polypropylene and with differing amounts of layers Core 1S and 2S Unique to OviTex is its composition which consists of essential components required for regeneration of host tissue Additionally the coupling of an ECM with a absorbable synthetic fiber provide strength without the need to cross-link the ECM Moreover OviTex is lower in costs than any other biological mesh on the market Since the use of synthetic meshes in pelvic floor surgery has come under scrutiny patients are tempted to undergo a resection rectopexy as an alternative to VMR with polypropylene Apart from the fact that the resection is associated with a higher risk of complications due to the application of an anastomosis the recovery time is much longer The hospitalization period would be longer and therefore the costs compared to prolapse surgery with OviTex would be higher
Preliminary results of a recent pilot study at Meander MC showed that the use of an OviTex PGA with absorbable grid mesh in the pelvic floor is feasible and safe Nevertheless 2 out of 11 patients who completed follow-up of 6 months showed an early anatomical recurrence This suggests that the use of permanent synthetic fiber may be necessary for a more durable repair and fewer recurrences than using OviTex PGA Although resistance against synthetic grafts is growing OviTex Permanent contains 96 sheep ECM and only 4 polymer compared to the standard Prolene mesh which is 100 polymer polymer areal density 16gm2 OviTex 1S vs 76gm2 prolene Furthermore the polymer is embedded in the ECM which further attenuates any inflammatory response Observations in primates show that the minimized amount of embedded synthetic reinforcement results in an implant that histologically behaves like a biologic mesh yet maintains its functional structure This is the first prospective multicenter study using a OviTex 1S mesh Although the material ovine was studies before little is known about the feasibility of enrolling these patients into randomised studies in the Netherlands and about the feasibility safety and tolerance of the OviTex 1s is this setting Therefore the investigators decided to start with a phase II study This allows for adequate monitoring of the feasibility safety and tolerance of the experimental treatment
There are no studies comparing OviTex to the current standard Prolene PMN3 Ethicon Inc Johnson Johnson Amersfoort The Netherlands Therefore a comparative study should be conducted before OviTex is used as a biologic alternative for polypropylene in VMR on a larger scale Following the OviTex pilot study the investigators aim to conduct a follow-up study ProTex trial in which both in the short and longer term the efficacy of the OviTex mesh in pelvic floor surgery will be assessed in comparison with the current standard polypropylene by means of a non-inferiority test
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None