PERMACOL IMPLANT EVIDENCE SUMMARY - Medtronic · EVIDENCE ・ Non-systematic literature searches...

PERMACOL™

IMPLANTEVIDENCE SUMMARY

Use of Permacol™ surgical implant in a contaminated or infected field may lead to a weakening or breakdown of the implant. Treat any existing or suspected infection according to accepted medical practice before implanting the device.

HERNIA CARE MESH FIXATION BIOLOGICS DISSECTION

CONTENTOUTLINE・ Abdominal wall reconstruction

・ Consequence of postoperative infections

・ Use of biologic grafts

・ Permacol™: Production specifications

・ Permacol™: The evidence

・ Other xenografts: Overall evidence

・ Future evidence


ABDOMINAL WALL RECONSTRUCTION

Repair of abdominal wall defects may be needed during:・Complex abdominal surgeries

・Large ventral/incisional hernia


COMPLEX AND CHALLENGING SURGERY

Common patient characteristics:

・One or more comorbidities

・Clean/contaminated, contaminated or dirty surgical field

・High risk of postoperative infections

・Requiring component separation


CONSEQUENCE OF POSTOPERATIVE INFECTIONS・ Recurrence

・ Serious wound or mesh infection

・ Mesh explantation

・ Other serious complications


USE OF BIOLOGICGRAFT

Clinical argument

・Similar characteristics to synthetic meshes:

- Enough mechanical strength

- Supports tissue ingrowth and regeneration

・Reduces foreign-body inflammatory response

・Allows neovascularization


USE OF BIOLOGICGRAFT

Economic argument

・Reduces number and time of operation

・Shortens hospital stay

・Reduces costs for further operationand care

・High cost for graft offset by shortened hospital stay and reduced risk of re-operation


PERMACOL™

SURGICAL IMPLANT・Made of >99% collagen

・Natural cross-links exist in collagen for strength

・The addition of chemical cross-links provide collagen with added strength and protection in contaminated/infected sites

・Chemical cross-links modify 2 of 1000 amino acids (0.2%) in a single collagen molecule of Permacol™


Permacol™

Surgical Implant

PERMACOL™ SURGICAL IMPACTASSESSING THE CLINICAL EVIDENCE

・Non-systematic literature searches were performed using PubMed, MEDLINE, Embase and the Cochrane Library in July 2013

・Evidence is limited to clinical studies published in peer-reviewed journals in English during the period 2004–2013

・The level of the evidence is assessed according to Oxford Centre for Evidence-Based Medicine, 2011 version

・The quality of the evidence is assessed using Modified Methodological Index of Non-RandomisedStudies (MINORS) scores. Studies with a MINORS score lower than 8 have not been included

・If the information is available, the author-assessed surgical wound classification is presented


LEVELS OF EVIDENCEOxford Centre for Evidence-Based Medicine, 2011 version

Question: Does this intervention help? (treatment benefits)


Level* Description

Level 1 Systematic review of randomized trials, or n-of-1 trials

Level 2 Randomized trial or observational study with dramatic effect

Level 3 Non-randomized controlled cohort/follow-up study**

Level 4 Case-series, case-control studies, or historically controlled studies**

Level 5 Mechanism-based reasoning

* Level may be downgraded on basis of study quality, imprecision, indirectness, because of inconsistencybetween studies, or because the absolute effect size is very small; Level may be upgraded if there is a large or very large effect size.

** A systematic review is generally better than an individual study.*** For Medtronic Internal use only

Evidence gradin***

Positive for Medtronic Permacol™ Surgical Implant, superior to the comparator, or equivalent to the comparator where effect is considered optimalNeutral for Medtronic Permacol™ Surgical Implant or comparable to the comparatorNegative for Medtronic Permacol™ Surgical Implant, or the comparator shows superiority over Medtronic Permacol™

Source: Oxford Centre for Evidence-Based Medicine.

MODIFIED METHODOLOGICAL INDEXOF NON-RANDOMISED STUDIES (MINORS)

Item Criteria Option Score

1 A clearly stated aim Not reportedPartially reported, no clear aimClear aim

012

2 Minimum of 5 patients included NoYes

02

3 Inclusion of consecutive patients Not reportedPatients in a certain time periodConsecutive patients + characteristics

012

4 Diagnostic modality of follow-up Not reported/unclear/telephone usedClinical examinationClinical examination + CT/Ultrasound

012

5 Surgical methods (i.e., anatomic placement of prosthesis, surgical technique, bridge/reinforcement used)

Not reportedIncompleteReported clearly, appropriate to aim

012

6 Endpoints clearly stated in methods section Not reported/unclearStated but inadequateClearly stated

012

7 Endpoints appropriate to aim Not reportedRecurrences onlyRecurrences and postoperative complication

012

Maximum score 14


Source: Slater et al. Am J Surg 2013;205:220-30

SURGICAL WOUNDCLASSIFICATION

Class Description

Class I. Clean An uninfected operative wound in which no inflammation is encountered and the respiratory, alimentary, genital, or uninfected urinary tract is not entered. In addition, clean wounds are primarily closed and, if necessary, drained with closed drainage. Operative incisional wounds that follow nonpenetrating (blunt) trauma should be included in thiscategory if they meet the criteria.

Class II. Clean-contaminated An operative wound in which the respiratory, alimentary, genital, or urinary tracts are entered under controlled conditions and without unusual contamination. Specifically, operations involving the biliary tract, appendix, vagina, and oropharynx are included in this category, provided no evidence of infection or major break in technique isencountered.

Class III. Contaminated Open, fresh, accidental wounds. In addition, operations with major breaks in sterile technique (e.g., open cardiac massage) or gross spillage from the gastrointestinal tract, and incisions in which acute, nonpurulent inflammation is encountered are included in this category.

Class IV. Dirty Old traumatic wounds with retained devitalized tissue and those that involve existing clinical infection or perforated viscera. This definition suggests that the organisms causing postoperative infection were present in the operative field before the operation.


Source: Mangram AJ et al. Guideline for Prevention of Surgical Site Infection, 1999. Centers for Disease Control and Prevention (CDC)

Amount of evidence5 studies

1 study

OUTCOMES: CLINICAL EVIDENCE OVERVIEW


Outcomes Evidence Level MINORS* Evidence Grading

Recurrence 4 8-13

Infections 4-5 8-13

Other complications 4 8-13

Pain 4 13

Adhesions 5 n/a

Implant degradation 5 n/a

Inflammatory response 5 n/a

Tissue integration 5 n/a

Neovascularization 5 n/a

Evidence gradin**

Positive for Medtronic Permacol™ Surgical Implant, superior to the comparator, or equivalent to the comparator where effect is considered optimalNeutral for Medtronic Permacol™ Surgical Implant or comparable to the comparatorNegative for Medtronic Permacol™ Surgical Implant, or the comparator shows superiority over Medtronic Permacol™

* The maximum possible MINORS score is 14** For Medtronic Internal use only

OUTCOME: RECURRENCE


Level MINORS Grading Mesh Title

4 11/14 Permacol ™ Use of porcine dermal collagen graft (Permacol) for hernia repair in contaminated fields

4 11/14 Permacol ™, Composix Cross-linked acellular porcine dermal collagen implant in laparoscopic ventral hernia repair: case-controlled study of operative variables and early complications

4 13/14 Permacol ™ Evaluation of porcine dermal collagen (Permacol) used in abdominal wall reconstruction

4 10/14 Permacol ™ Porcine dermal collagen (Permacol) for abdominal wall reconstruction

4 9/14 Permacol ™, Alloderm, Goretex, Vicryl, others

Synthetic and biologic mesh in component separation: a 10-year single institute review

4 12/14 Permacol ™ Abdominal wall reconstruction with dual layer cross-linked porcine dermal xenograft: the “pork sandwich" herniorraphy

4 12/14 Permacol ™ Experience with porcine acellular dermal collagen implant in one-stage tension-free reconstruction of acute and chronic abdominal wall defects

4 8/14 Permacol ™ Initial evaluation of Permacol bioprosthesis for the repair of complex incisional and parastomal hernias

4 13/14 Permacol ™ + Premilene®

Initial experience of double-layer tension free reconstruction of abdominal wall defects with porcine acellular dermal collagen implant and polypropylene mesh

OUTCOME: INFECTIONS



4 11/14 Permacol ™ Use of porcine dermal collagen graft (Permacol) for herniarepair in contaminated fields




4 12/14 Permacol ™ Abdominal wall reconstruction with dual layer cross-linkedporcine dermal xenograft: the “pork sandwich" herniorraphy




Initial experience of double-layer tension free reconstruction ofabdominal wall defects with porcine acellular dermal collagen implant and polypropylene mesh

5 n/a Permacol ™ Human in vivo cellular response to a cross-linked acellular collagen implant

OUTCOME: OTHER COMPLICATIONS



4 11/14 Permacol ™ Use of porcine dermal collagen graft (Permacol) for herniarepair in contaminated fields




4 12/14 Permacol ™ Abdominal wall reconstruction with dual layer cross-linkedporcine dermal xenograft: the “pork sandwich" herniorraphy




Initial experience of double-layer tension free reconstruction ofabdominal wall defects with porcine acellular dermal collagen implant and polypropylene mesh

OUTCOME: OTHER OUTCOMES




Initial experience of double-layer tension free reconstruction of abdominal wall defects with porcine acellular dermal collagen implant and polypropylene mesh

Pain



Adhesion



Implant degradation



Inflammatory response



Tissue integration



Neovascularization

EVIDENCE BRIEF:CATENA ET AL. 2007


Title Use of porcine dermal collagen graft (Permacol) for hernia repair in contaminated fields

No. of patients 7 Country Italy

Type of surgery Repair of complicated incisional hernia

Previous surgery Major abdominal surgery or hysterectomy

Defect size 10 × 11 to 14 × 13 cm

Contamination Contaminated fields in all patients

Comorbidities COPD, IHD, previous DVT, lymphoma; others not reported

Implant Permacol™

Implant position Underlay (71%), onlay (29%)

Follow-up period Mean 11.1 months (range 7-18 months)

Publication Hernia 2007;11:57-60

COPD: Chronic obstructive pulmonary disease, IDH: Ischemic heart disease, DVT: Deep vein thrombosis.

Outcomes

Recurrence No recurrence

Complications 14.2% (n=1) had acute postoperative pneumonia

Infections No wound infection

Pain Not reported

Recurrence

Infections

Other complications

Evidence level 4

MINORS score 11/14 (79%)

Authors’ conclusions:

Use of Permacol™ is potentially safe and efficient in contaminated fields

EVIDENCE BRIEF:COBB & SHAFFER 2005


Title Cross-linked acellular porcine dermal collagen implant inlaparoscopic ventral hernia repair: case-controlled study of operative variables and early complications

No. of patients 139 Country USA

Type of surgery Repair of incisional hernia and primary ventral hernia

Previous surgery Not reported

Defect size Not reported

Contamination Wound contamination in 7.2% patients (n=4) in the Permacol™ group

Comorbidities Mean BMI 33.0-33.1 kg/m2; others not reported

Implant Permacol™ (n=55) vs Composix (n=84, historical controls)

Implant position Laparoscopically inserted

Follow-up period Permacol™ group: 14 months; Composix group: 31 months (averages)

Publication Int Surg 2005;90:S24-9

Outcomes

Recurrence Permacol™ group: 6.6% (n=4); Composix group: 1.2% (n=1); no significant difference between groups

Complications Permacol™ group: 13.3% (n=8); Composix group: 13.1% (n=11)

Infections Wound infections in Permacol™ group: 3.3% (n=2, one requiring meshremoval); Composix group: 2.4% (n=2, both requiring mesh removal)

Pain Not reported

Recurrence

Infections

Other complications

Evidence level 4



Permacol™ is safe for use in laparoscopic ventral hernia repair

EVIDENCE BRIEF:HSU ET AL. 2009


Title Evaluation of porcine dermal collagen (Permacol) used in abdominal wall reconstruction


Type of surgery Repair of abdominal wall hernia

Previous surgery Laparotomy incision or open abdomen after trauma

Defect size Mean 150 cm2 (range 10-600 cm2)

Contamination Not reported

Comorbidities Mean BMI 34 kg/m2, BMI > 30 kg/m2 (57%), hypertension, diabetes

Implant Permacol™

Implant position Underlay

Follow-up period Mean 16 months

Publication J Plast Reconstr Aesthet Surg 2009;62:1484-9

Outcomes

Recurrence P10.7% (n=3, one requiring re-operation)

Complications 7.1% (n=2) had minor complications (seroma plus cellulitis; localizedwound infection); 14.3% (n=4, none requiring implant removal) developed a chronic, non-infected fluid collection

Infections Not reported

Pain Not reported

Recurrence

Infections

Other complications

Evidence level 4



Permacol™ can be successfully used in the reconstruction of both small and large ventral hernias

EVIDENCE BRIEF:PARKER ET AL. 2006


Title Porcine dermal collagen (Permacol) for abdominal wallreconstruction


Type of surgery Abdominal wall reconstruction

Previous surgery 56% (n=5) had previous incisional hernia repair


Contamination Class II, III or IV contamination in 56% (n=5)

Comorbidities Obesity (56%), diabetes (44%), hypertension (44%), COPD (22%),smoking (33%), metastatic cancer (22%)

Implant Permacol™


Follow-up period Mean 18.2 months

Publication Curr Surg 2006;63:255-8

Outcomes

Recurrence 11% (n=1) following mesh removal after wound infection

Complications 22% (n=2): exposure of graft due to skin separation plus 1 death due to unrelated causes

Infections 11% (n=1) leading to mesh removal

Pain Not reported

Recurrence

Infections

Other complications

Evidence level 4



Permacol™ is a safe and acceptable alternative to synthetic mesh in repair of complex abdominal wall defects

EVIDENCE BRIEF:SAILES ET AL. 2010


Title Synthetic and biologic mesh in component separation: a 10-year single institute review


Type of surgery Abdominal wall reconstruction

Previous surgery Not reported



Comorbidities In biologic mesh group: diabetes (17%), smoking (20%), others (age > 65 years, obesity) not specified

Implant Permacol™ (n=13), Alloderm (n=100), Goretex (n=80), Vicryl (n=51),other (n=76)

Implant position All meshes implanted using component separation with onlay mesh

Follow-up period Not reported

Publication Ann Plast Surg 2010;64:696-8

Outcomes

Recurrence Permacol™ group: 8% (n=1); Alloderm group: 19% (n=19); Goretex 35% (n=28), Vicryl 18% (n=9), other 21% (n=16)

Complications Mesh-specific complication rates not reported

Infections Mesh-specific infection rates not reported

Pain Not reported

Recurrence

Infections

Other complications

Evidence level 4



There was no statistical significance for recurrence with respect to the type of mesh used

EVIDENCE BRIEF:SATTERWHITE ET AL. 2012

Title Abdominal wall reconstruction with dual layer cross-linked porcine dermal xenograft: the “pork sandwich" herniorraphy


Type of surgery Repair of large ventral hernia

Previous surgery Average of 2 previous abdominal operations

Defect size Mean 321 cm2 (range 100-1050 cm2)

Contamination Ostomy/enterotomy in 58% patients (n=11); enterocutaneous fistula in 26% (n=5)

Comorbidities Obesity (n=9), smoking history (n=3), diabetes (n=2), chronicimmunosuppression for transplantation (n=1), history of radiation (n=1)

Implant “Pork sandwich” group: Permacol™; historical case-control group: various types of biologic (including Permacol™) and synthetic meshes

Implant position Permacol™ “pork sandwich” group: one mesh underlay, one overlay toform the “pork sandwich”; control group: underlay or onlay

Follow-up period Permacol™ “pork sandwich” group: 11 months (range 1-33 months);control group: 15 months (1-71 months)

Publication J Plast Reconstr Aesthet Surg 2012;65:333-41

Outcomes

Recurrence Permacol™ “pork sandwich” group: no recurrences; control group: 19% (n=16), p=0.038

Complications Complication rate (53%) and re-operation rate (36%) in the Permacol™

“pork sandwich” group did not differ significantly from those in the control group (64% and 25%, respectively).

Infections Permacol™ “pork sandwich” group: 16% (n=3); control group: 27% (n=23) (p=not significant)

Pain Not reported

Recurrence

Infections

Other complications

Evidence level 4



Use of Permacol™ “pork sandwich” herniorraphy may be suitable for abdominal defects in patients with infection risk and comorbidities

EVIDENCE BRIEF:SHAIKH ET AL. 2007


Title Experience with porcine acellular dermal collagen implant in one-stage tension-free reconstruction of acute and chronic abdominal wall defects

No. of patients 20 Country Ireland

Type of surgery Repair of chronic/acute large incisional hernia or abdominal wall defects(CAWD/AAWD)

Previous surgery Not specified

Defect size Median 180 cm2 (range 96-850 cm2)

Contamination Not specified

Comorbidities Obesity (15%), diabetes (15%), Crohn’s disease (5%), COPD (5%)

Implant Permacol™


Follow-up period Median 18 months (range 6-36 months)

Publication World J Surg 2007;31:1996-72

Outcomes

Recurrence Overall: 15% (n=3); CAWD group: 8% (n=1/12); AAWD group: 25%(n=2/8)

Complications 35% (n=7), plus 1 death from unrelated causes

Infections 10% (n=2) of AAWD group had wound infections

Pain Not reported

Recurrence

Infections

Other complications

Evidence level 4


COPD: Chronic obstructive pulmonary disease


Permacol™ is useful for reconstruction of large acute and chronic abdominal wall defects. Medium-term recurrence rate is comparable to that with synthetic mesh repairs

EVIDENCE BRIEF:LOGANATHAN ET AL. 2010


Title Initial evaluation of Permacol bioprosthesis for the repair ofcomplex incisional and parastomal hernias

No. of patients 15 Country UK

Type of surgery Repair of large, complex and contaminated hernias

Previous surgery Median 3 (range 1-9) major abdominal procedures

Defect size Not specified

Contamination Not specified; some patients had contaminated field

Comorbidities Not specified

Implant Permacol™

Implant position Onlay or inlay

Follow-up period Median 12 months (range 4-63 months)

Publication Surgeon 2010;8:202-5

Outcomes

Recurrence 13% (n=2)

Complications 73% (n=11, none required mesh removal)

Infections 27% (n=4, none requiring mesh removal) had wound infections; 7% (n=1) each with an RTI or oral thrush

Pain Not reported

Recurrence

Infections

Other complications

Evidence level 4


RTI: Respiratory tract infection


Permacol™ appears resistant to infection and can be safely used for complex and contaminated hernia repair

EVIDENCE BRIEF:SHAIKH ET AL. 2012


Title Initial experience of double-layer tension free reconstruction ofabdominal wall defects with porcine acellular dermal collagenimplant and polypropylene mesh

No. of patients 10 Country Ireland

Type of surgery Repair of large abdominal wall incisional or umbilical hernias

Previous surgery Not specified; primary repairs in 5; recurrent repairs in 5

Defect size ≥75 cm2


Comorbidities 100% had comorbidities, including obesity (80%), diabetes (40%), cancer (20%), COPD (20%), IHD (20%), CCF (20%)

Implant Permacol™ plus Premilene® to form a double-layer

Implant position Underlay (Permacol™) and onlay (Premilene®)

Follow-up period Median 15.5 months (range 6-29 months)

Publication Ir J Med Sci 2012;181:205-9

Outcomes

Recurrence No recurrence

Complications 40% (n=4)

Infections 20% (n=2, none requiring mesh removal); 10% (n=1) LRTI

Pain No chronic pain reported on follow up

COPD: Chronic obstructive pulmonary disease, IHD: Ischemic heart disease, CCF: Congestive cardiacfailure. LRTI: Lower respiratory tract infection

Recurrence

Infections

Other complications

Pain

Evidence level 4



The use of a double-layer of Permacol™

and Premilene® in abdominal wall reconstruction is safe and effective.

EVIDENCE BRIEF:HAMMOND ET AL. 2008

Title Initial evaluation of Permacol bioprosthesis for the repair ofcomplex incisional and parastomal hernias

No. of patients 15 Country UK

Type of surgery Prevention of parastomal hernia in patients undergoing loop stomaformation; later reversed in 12


Implant Permacol™

Implant position Onlay (n=6) or sublay (n=9)

Follow-up period Median 7 months (range 1-8 months) in 12 who underwent stoma reversal; 12 months in all patients

Publication Br J Surg. 2008;95(4):438-46

Outcomes

Herniation 6.7% (n=1/15)

Infections 8% (n=1/12) developed infection requiring implant removal

Adhesions Adherence to bowel serosa was absent or limited

Microscopicfindings (from 11of 12 explantedimplants)

Mild-to-moderate non-foreign body inflammatory responseMinimal implant degradationNo evidence of fibrosis or implant contractionIncreased fibroblast integration and proliferationIncreased synthesis of neo-extracellular matrix proteinsNeovascularization at the periphery of the implant and via native poresOrganized deposition of neocollagenFibrovascular ingrowth* and extracellular matrix deposition were limited, but there was evidence that further ingrowth may occur with longer follow up

Herniation

Infection

Adhesion

Inflammatory response

Implant degradation

Tissue integration

Neovascularization

Evidence level 4



Permacol™ demonstrated excellent biocompatibility and resistance to degradation. However, fibrovascularingrowth and extracellular matrix formation were limited. It has excellent potential for soft tissue reinforcement.

*Attributed to the resistance of Permacol™’ to matrix metalloproteinases as a result of cross-linking

REFERENCES FOR PERMACOL™ SURGICAL IMPLANT1. Catena F et al. Use of porcine dermal collagen graft (Permacol) for hernia repair in contaminated fields. Hernia. 2007;11(1):57-60.

2. Cobb GA and Shaffer J. Cross-linked acellular porcine dermal collagen implant in laparoscopic ventral hernia repair: case-controlled study of operative variables and early complications. Int Surg. 2005;90(3 Suppl):S24-9.

3. Hammond TM et al. Human in vivo cellular response to a cross-linked acellular collagen implant. Br J Surg. 2008;95(4):438-46.

4. Hsu PW et al. Evaluation of porcine dermal collagen (Permacol) used in abdominal wall reconstruction. J Plast Reconstr Aesthet Surg. 2009;62(11):1484-9.

5. Loganathan A et al. Initial evaluation of Permacol bioprosthesis for the repair of complex incisional and parastomal hernias. Surgeon. 2010;8(4):202-5.

6. Parker DM et al. Porcine dermal collagen (Permacol) for abdominal wall reconstruction. Curr Surg. 2006;63(4):255-8.

7. Sailes FC et al. Synthetic and biological mesh in component separation: a 10-year single institution review. Ann Plast Surg. 2010;64(5): 696-8.

8. Satterwhite TS et al. Abdominal wall reconstruction with dual layer cross-linked porcine dermal xenograft: the "Pork Sandwich” herniorraphy. J PlastReconstr Aesthet Surg. 2012;65(3):333-41.

9. Shaikh FM et al. Experience with porcine acellular dermal collagen implant in one-stage tension-free reconstruction of acute and chronic abdominal wall defects. World J Surg. 2007;31(10):1966-72; discussion 1973-4, 1975.

10. Shaikh FM et al. Initial experience of double-layer tension free reconstruction of abdominal wall defects with porcine acellular dermal collagen implant and polypropylene mesh. Ir J Med Sci. 2012;181(2):205-9.


Back to Permacol™ Surgical Implant clinical evidence overview

Type Product name Manufacturer

Cross-linked porcine dermal collagen

CollaMend™ FM Implants Bard

Non-cross-linked porcine dermalcollagen

Strattice™ Reconstructive Tissue Matrix

XenMatrix™ Surgical Graft

LifeCell

Bard

Porcine small intestine submucosa

Biodesign® (Surgisis®) Cook Medical

Bovine dermal collagen*

SurgiMend® TEI Biosciences

Bovine pericardium* Peri-Guard® Repair Patch

Veritas Collagen Matrix

Tutomesh®

Synovis

Baxter

Tutogen


OTHER XENOGRAFTSUSED FOR ABDOMINAL WALL RECONSTRUCTION

* Not enough clinical evidence available to make assessment

Outcomes Assessment

Recurrence Recurrence rates ranged from 0 to 44% (n=8/18); recurrences all seen in cases where mesh was placed using the interpositionaltechnique; no recurrences seen when intraperitoneal mesh wasreinforced with an onlay synthetic patch, or was placed onlay or inlay

Infections Infection rates ranged from 22% to 40%

Other complications

Rates of seroma/hematoma development ranged from 17% to 33%


OUTCOMES WITH OTHER XENOGRAFTS USEDFOR ABDOMINAL WALL RECONSTRUCTIONCross-linked porcine dermal collagen: CollaMend™

References

Outcomes Assessment

Recurrence Recurrence rates ranged from 0% to 90%. Higher recurrence rates achieved if wound was bridged by the biologic graft.

Infections Infection rates ranged from 0% to 54%

Other complications

Complication rates ranged from 22% to 29%


OUTCOMES WITH OTHER XENOGRAFTSFOR ABDOMINAL WALL RECONSTRUCTIONNon-cross-linked porcine dermal collagen: Strattice™

References

Outcomes Assessment

Recurrence Recurrence rate ranged from 5-8%

Infections Infection rates ranged from 0 to 8%

Other complications

Rates of seroma development ranged from 0% to 42%

Non-cross-linked porcine dermal collagen: XenMatrix™

References

Outcomes Assessment

Recurrence Recurrence rates ranged from 0 to 30%

Infections Infection rates ranged from 0 to 40%

Other complications

Complication rates ranged from 10% to 42%


OUTCOMES WITH OTHER XENOGRAFTSFOR ABDOMINAL WALL RECONSTRUCTIONPorcine small intestine submucosa: Biodesign® (Surgisis®)

References

REFERENCES FOR OTHER XENOGRAFTSCross-linked porcine dermal collagen

1. Chavarriaga LF et al. Management of complex abdominal wall defects using acellular porcine dermal collagen. Am Surg. 2010;76(1): 96-100.

2. Nasajpour H, LeBlanc KA, Steele MH. Complex hernia repair using component separation technique paired with intraperitoneal acellular porcine dermis and synthetic mesh overlay. Ann Plast Surg. 2011;66(3):280-4.

Non-cross-linked porcine dermal collagen: Strattice™

1. Butler CE and Campbell KT. Minimally invasive component separation with inlay bioprosthetic mesh (MICSIB) for complex abdominal wall reconstruction. Plast Reconstr Surg. 2011;128(3):698-709.

2. Itani KM et al. Prospective study of single-stage repair of contaminated hernias using a biologic porcine tissue matrix: the RICH Study. Surgery. 2012;152(3):498-505.

3. Patel KM et al. The use of porcine acellular dermal matrix in a bridge technique for complex abdominal wall reconstruction: an outcome analysis. Am J Surg. 2013;205(2):209-12.

4. Rosen MJ et al. A novel approach for the simultaneous repair of large midline incisional and parastomal hernias with biological mesh and retrorectus reconstruction. Am J Surg. 2010;199(3):416-20; discussion 420-1.

5. Shah BC et al. Not all biologics are equal! Hernia. 2011;15(2):165-71.

6. Singh DP et al. A modified approach to component separation using biologic graft as a load-sharing onlay reinforcement for the repair of complex ventral hernia. Surg Innov. 2014;21(2):137-46.


REFERENCES FOR OTHER XENOGRAFTSNon-cross-linked porcine dermal collagen: XenMatrix™

1. Alicuben ET and Demeester SR. Onlay ventral hernia repairs using porcine non-cross-linked dermal biologic mesh. Hernia. 2013; [Epub ahead of print]

2. Byrnes MC et al. Repair of high-risk incisional hernias and traumatic abdominal wall defects with porcine mesh. Am Surg. 2011;77(2):144-50.

3. Diaz-Siso JR et al. Abdominal wall reconstruction using a non-cross-linked porcine dermal scaffold: a follow-up study. Hernia. 2013;17(1): 37-44.

4. Pomahac B and Aflaki P. Use of a non-cross-linked porcine dermal scaffold in abdominal wall reconstruction. Am J Surg. 2010;199(1):22-7.

5. Rosen MJ et al. A novel approach for the simultaneous repair of large midline incisional and parastomal hernias with biological mesh and retrorectusreconstruction. Am J Surg. 2010;199(3):416-20; discussion 420-1.

Porcine small intestine submucosa

1. Eid GM et al. Repair of ventral hernias in morbidly obese patients undergoing laparoscopic gastric bypass should not be deferred. Surg Endosc. 2004;18(2):207-10.

2. Gupta A et al. Ventral herniorrhaphy: experience with two different biosynthetic mesh materials, Surgisis and Alloderm. Hernia. 2006;10(5): 419-25.

3. Helton WS et al. Short-term outcomes with small intestinal submucosa for ventral abdominal hernia. Arch Surg. 2005;140(6):549-60; discussion 560-2.

4. Ueno T, Pickett LC, de la Fuente SG, Lawson DC, Pappas TN. Clinical application of porcine small intestinal submucosa in the management of infected or potentially contaminated abdominal defects. J Gastrointest Surg. 2004;8(1):109-12.


FUTURE REFERENCEOngoing and recently completed clinical trials registered at ClinicalTrials.gov


NCT ID Title Device Sponsors Completion

NCT01426477 Veritas in Non-Bridging Ventral Hernia Repair (VIBE) Veritas CollagenMatrix

SynovisSurgicalInnovations

August 2017

NCT01268514 ENHANCE: A Prospective EvaluatioN of Permacol™ in the Repair of Complex AbdomiNal Wall CasEs

Permacol™ BiologicalImplant

Medtronic December 2016

NCT02228889 Prospective Trial Comparing the Performance Profiles of Two Non-Cross-Linked Porcine Dermal Matrices in Abdominal Wall Reconstruction

Strattice; XenMatrix Janis, JeffreyE, MD

November 2016

NCT02129140 Observational Study to Evaluate Ventral Incisional Hernia Repair Using a Biologic Mesh (Cook Biodesign)

Biodesign mesh Mount SinaiSchool ofMedicine

April 2016

NCT01987700 Multi-Center Study To Examine The Use Of Flex HD® And Strattice In The Repair Of Large Abdominal Wall Hernias

Flex HD®;Strattice™

Musculoskeletal TransplantFoundation

July 2015

NCT02168231 Abdominal Wall Repair With Strattice in Germany: a Cohort Study (BASE cohort)

Stratticebiological mesh

Erasmus MedicalCenter

February 2015

NCT02166112 The Permacol Dutch Cohort Study Permacol mesh Erasmus MedicalCenter

May 2014

http://www.clinicaltrials.gov/ct2/show/NCT01426477?term=collagen+mesh&cond=Hernia+abdominal&rank=5

http://www.clinicaltrials.gov/ct2/show/NCT01268514?term=permacol&rank=4

http://www.clinicaltrials.gov/ct2/show/NCT02228889?term=xenmatrix&rank=2

http://www.clinicaltrials.gov/ct2/show/NCT02129140?term=Biodesign+hernia&rank=1

http://www.clinicaltrials.gov/ct2/show/NCT01987700?term=strattice&rank=5

http://www.clinicaltrials.gov/ct2/show/NCT02168231?term=collagen+mesh&rank=13

http://www.clinicaltrials.gov/ct2/show/NCT02166112?term=permacol&rank=1

GENERAL REFERENCES1. Balayssac D et al. Use of permacol in parietal and general surgery: a bibliographic review. Surg Innov. 2013;20(2):176-82.

2. Centre for Evidence Based Medicine. OCEBM levels of evidence system. Available at http://www.cebm.net/index.aspx?o=5653.

3. Mangram AJ et al. Guideline for Prevention of Surgical Site Infection, 1999. Centers for Disease Control and Prevention (CDC) Hospital Infection Control Practices Advisory Committee. Am J Infect Control. 1999;27(2):97-132; quiz 133-4; discussion 96.

4. Slater NJ et al. Biologic grafts for ventral hernia repair: a systematic review. Am J Surg. 2013;205(2):220-30.


http://www.cebm.net/index.aspx?o=5653

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