Studies Flashcards
Badylak- Load Transfer
Pre clinical
No patients
Phasix load transfer
As mesh strength decreases over time, new healthy abdominal wall strength increases. Resulting in a repair that is 3X the strength pre repair
Immediate reinforcement and strength while gradually transferring load bearing responsibility to the patient
Roth 18 month study
Clinical
Prospective
121 patients
Phasix - retro rectus & onlay
- 18 month follow up
- 9% total recurrence
- 2.5% recurrence rate in procedures that followed the mesh overall protocol ( 3 to 5 we say 5 to 7 cm from the defect). 8 out 11 total recurrences were from procedures with a protocol breach
- 9% SSI ; no infected mesh required
- 6% seroma requiring a drain or wound vac
Ianetti
Clinical
Retrospective
74 patients
XenAB
- follow up 6 months
- post op seroma formation 5.4%. 1 patient required drainage
- recurrence rate 5.4% all comers
- 6.8% developed an SSO. Much better than Rich or Cobra study
Pomahac
Clinical
Xenmatrix
Retrospective
40 patients. 38- 2 died organ failure not graft related
* longes follow up of any study w/ 40.1 month follow up
* recurrence rate 7.9%
* avg defect 435 cm -> 40% class 2-4
Brynes/Croston
Clinical
Retrospective
57 patients
XenMantrix
7.2% recurrence rate “all comers” grades 1-4
30.6 month avg follow up
0 seromas, 0% SSI
80% of patients were clean contaminated/ contaminated fields
Buell
Clinical Retrospective 73 patients Phasix Vs Biologics- cost savings 42 Strattice cases Vs 31 Phasix cases
Independentantly funded (Bard has nothing to do with it)
Phasix shorter drain time by 4 days compared to Strattice
Recurrence rate 6.5% to 23.8% strattice
Follow up 90 days
Fewer complications 22.6% to 40.5%
Cost difference $9,570 Biologics Vs Phasix
Liked Strattice better. Hospital was pushing cost savings. Tried it to appease the hospital and saw results so decided to do a study an independent study
Iannitti “ Strength of Tissue of Attachment”
Pre Clinical
Prospective
12 Female Swine
Polypro + ePTFE = 10 X 16 Sheet
- 4-6% recurrence rate in 8-36 months
- majority of tissue ingrowth 1st 2 weeks
Voeller- “ Ventralex Mesh in Umbilical/ Epigastric Hernia Repairs: Clinical Outcomes and Complications”
Clinical
Retrospective
88 patients
Umbilical/Epigastric w/ out mesh up to 40% recurrence rate. Ventralex.
* 0 recurrence
- 93% of patients sent home same day
*1 Seroma + 2 mesh infections that needed removal; 1 case post op urinary retention
* Study showed Ventralex lowered recurrence rate from 40% (No mesh) to 0%
* Follow up 8 days to 3.1 years
Matthew “120 Days Comparative Analysis of Adhesion”
Pre clinical
Prospective
41 Rabbits
All competitors
- 120 day follow up
- Atrium sponsored Study- 3rd Party Strudy
- We have the best adhesion barrier - Permeant and absorbable
- ePTFE & Sepra Mesh in study
Iannitti “ technique and Outcomes of Abdominal Incisional Hernia Repair Using a Synthetic Composite Mesh: A report of 455 cases”
Clinical Prospective 455 Composix ( Ventrio w ePTFE) - Multi Center * Used to show efficiency of Ventrio
- Recurrence 1%, 6 patients
- 29.3 Month Follow Up
- mean defect size= 44 cm mean size of 213 cm
- 70% of these patients had a recurrent hernia before using Ventrio ST
- Ave length hospital stay= 1.1 days
Conclusion: OVHR w a composite mesh intro abdominally resulted in shorter hospital stay, early and late complication rate. Lower overall infection and Lower recurrence rate.
Byrd- “ Evaluation of absorbable and permanent mesh fixation devices; adhesion formation and mechanical strength.”
Pre Clinical
Prospective
15 Swine
SorbaFix & PermaFix (LVHR)
- FU 4 weeks
- Perma Fix and Sorba Fix fasteners had fewer adhesions than ProTak, when adhesions were present, there adhesions were easily lysed.
- ProTak fasteners formed dense adhesions
Bard “ OptiFix vs SecureStrap”
Pre Clinical Our Study- BD did Prospective 10 female Swine OptiFlex ( w/ Ventralight ST)
- An Implementation, SecureStrap induced a significantly higher degree of trauma that optifiix. The trauma surrounding secure strap included significantly greater degree of hemorrhage a cute scheme.
Novitsky- “ Evaluation of a novel permanent capped helical coil fastener in a province model of LVHR”
Pre Clinical
Prospective
12 Female Swine
Capture
FU= 80 days
- HC- capped (Capsure) fasteners demonstrated rapid re peritoneal diamond tissue attachment score compared to HC Non capped (ProTak)
- HC- capped (Capsure) had a significantly higher % of properly engaged fasteners compared to HC- Non capped (Pro Tak) 99.7% vs 86.5%
Millikan “ A long term evaluation of the modified mesh plug herioplasty in over 2,000 patients”
Clinical
Prospective
2038 Patients
Perfix Plug
- 99 % follow 2 - 10 yrs later
- gave patients free cancer screening
- Clinically proven technique
- .15% recurrence- 3 recurrences
- 28 minute avg operation
- no mesh infections
