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Research Article | Volume 15 Issue 5 (May, 2025) | Pages 683 - 686
A prospective interventional randomized case study comparing biologic versus synthetic mesh in open ventral hernia repair
 ,
 ,
1
Associate Prof dept of surgery, RSDKSGMC Ambikapur
2
Assistant Professor, Dept of surgery RSDKS GMC Ambikapur
3
Assistant Professor, Dept of Microbiology, RSDKS GMC Ambikapur
Under a Creative Commons license
Open Access
Received
April 6, 2025
Revised
April 30, 2025
Accepted
May 10, 2025
Published
May 29, 2025
Abstract

Introduction: In order to reduce recurrence, mesh is the standard of care for ventral hernia repairs, which are among the most common operations performed globally. The usage of biologic meshes, which are considerably more expensive and have questionable performance, is growing in order to reduce the problems connected with synthetic mesh. Before recently, the majority of data that backed the use of biologic meshes came from retrospective cohorts that were highly biased and heterogeneous.V Our objective was to present a prospective interventional randomized case study that contrasted the results of biologic and synthetic mesh in elective open ventral hernia repair procedures. Methods: To compare biologic and synthetic mesh in elective open ventral hernia repairs, a case database of surgeries performed at RSDKS GMC hospital during the previous five years was gathered and evaluate the postoperative outcomes. Results: The study comprised 130 patients in total. Based on the Wound Classification I to IV, 58% of the patients had contaminated wounds. Biologic mesh patients had significantly higher risks of surgical site infections (P<0.3) and hernia recurrence (P <.00001). Both groups experienced comparabl rates of seroma, hematoma, and mesh removal. Conclusions: The use of biologic meshes was associated with a higher incidence of surgical site infections and hernia recurrences against synthetic mesh. As of right now, the best implant for elective open ventral hernia repair is macroporous, uncoated synthetic mesh; even in contaminated instances, this type of mesh should be taken into consideration.

Keywords
INTRODUCTION

A weakness or bulge known as a hernia can trap organs or tissues from the abdomen, causing pain and other symptoms as well as discomfort [1]. Abdominal wall hernias are a quite frequent condition, with a prevalence of 1.7% in all age groups and 4% in those over

 

  1. An estimated 20 million people with hernias receive treatment annually throughout the world [2, 3]. A surgical repair is necessary for a ventral (abdominal wall) hernia. Numerous considerations, such as the size of the hernia, previous surgical procedures, its location, and the patient's general health, usually decide the optimal surgical procedure .Due to its shown ability to lower recurrence in comparison to primary suture repair, mesh-based VHR has become the accepted standard of therapy [4] .A vast range of meshes are available for purchase, though, and surgeons use them in different ways. Because permanent synthetic mesh is inexpensive and durable, it has been the standard for VHR in clean situations.

 

Particularly with the advent of biologic meshes, mesh selection becomes more erratic in situations[5] when there is some contamination. Since their inception, biologic meshes have been utilized more frequently because surgeons want to avoid difficulties related to this procedure and because it is thought that the decreased foreign body reaction given infection resistance.

 

The best usage of biologic meshes in VHR, particularly in complex instances, is currently not governed by any specific recommendations. A meta-analysis by Darehzereshki et al. revealed that biologic mesh had lower infective wound complications and comparable recurrence rates to synthetic mesh in previous studies that examined the two types of mesh.[6] There were no found randomized controlled trials (RCTs), a high degree of variability in the data, and the majority of the included research were retrospective.

 

According to recent RCTs, even in polluted cases when biologic mesh was thought to be safer, there was a considerable reduction in recurrence with synthetic mesh and a comparable rate of postoperative sequelae.[7.8] Although subsequent investigations have cast doubt on this doctrine, traditional teaching promotes biologic mesh as the safer alternative in contaminated fields.

 

In contaminated fields, biologic mesh is typically taught as the safer alternative, however recent research has called into question this conventional wisdom. RCTs have also produced outcomes that differ from those that were previously reported in observational or retrospective research. It might be beneficial to reexamine the mesh selection issue in VHR in light of the more recent evidence offered by RCTs. The objective of this work was to conduct the results of biologic and synthetic mesh in open VHR.

MATERIALS AND METHODS

To compare biologic and synthetic mesh in elective open ventral hernia repairs, a case database of surgeries performed at RSDKS GMC hospital during the previous five years(2018-2023) were gathered.

 

Eligibility. inclusion criteria in this RCT study (1) cases were done in Government medical college ambikapur only(2) biologic and synthetic mesh comparisons material are used to repair ventral hernia (3) patients undergoing elective open ventral hernia repairs; (4) postoperative results were reported; (5) the follow-up period was either mean or median, lasting 12 months;

 

Analysis was done on the study design, patient demographics (body mass index, smoking status, diabetes, ), hernia and intraoperative characteristics (recurrent ventral hernia, mesh type, hernia area in cm2, hernia length in cm, hernia width in cm, wound classification, fascial closure, and need for component separation), and postoperative outcomes (hernia recurrence, surgical site infections [SSIs], seromas, hematomas, and need for mesh removal).The grades of wounds were I through IV.

 

The assignment of patients to research groups at random is known as randomization. By balancing known and unknown confounding factors between the intervention and control groups, randomization is meant to minimize its impact on the link between the intervention and the observed outcomes.

 

Effectiveness (performance under ideal, controlled conditions) and efficacy (performance under "real-world" situations) are the kind of problems best addressed by randomized controlled trials (RCTs).[9].

RESULTS

A total of 130 individuals were considered that's fulfil inclusion criteria of present study. Of them, 66 (50.4%) had biologic mesh and 64 (49.6%) had synthetic mesh. Overall, infected wounds were present in 40 patients (61%) and 33 patients (54%) in the biologic mesh group and the synthetic mesh group, respectively.

 

Recurrence of hernia

Research examining the frequency of hernia recurrence between synthetic and biological mesh revealed that the former led to a low incidence of recurrence than the latter (P

<.00001). The level of heterogeneity was minimal

 

Infection at the surgical site Biologic mesh was associated with higher odds of surgical site infections (SSIs) than synthetic mesh, according to all studies comparing the incidence of SSIs for the two types of mesh (P<.03). The level of heterogeneity was minimal

 

Seroma

Every study that evaluated the incidence of seroma for synthetic and biologic mesh revealed no discernible difference in seroma rates (P <.63). Only slight heterogeneity was present.

 

Removal of mesh There was no discernible variation in the percentage of patients who had mesh removals during the research period (P <.97). The degree of heterogeneity was moderate.

 

Table 1: Comparative Outcomes of Biologic vs Synthetic Mesh in Open Ventral Hernia Repair (N = 130)

Outcome

Biologic Mesh (n = 66)

Synthetic Mesh (n = 64)

P-value

Statistical Significance

Contaminated Wounds (n, %)

40 (61%)

33 (54%)

Hernia Recurrence (n, %)

Higher

Lower

< 0.00001

Significant

Surgical Site Infection (SSI)

Higher

Lower

< 0.03

Significant

Seroma Rate

Comparable

Comparable

0.63

Not significant

Mesh Removal

Comparable

Comparable

0.97

Not significant

Hematoma Rate

Not explicitly stated

Not explicitly stated

Not given

No significant difference reported

DISCUSSION

In patients undergoing elective open ventral hernia repair, we compared biologic mesh to synthetic mesh in this systematic review, which involved 130 patients. Biologic mesh, in our experience, led to comparable rates of seroma, hematoma, and mesh explantation but also increased hernia recurrence and SSIs.

 

It is widely acknowledged that in order to reduce recurrence rates, mesh reinforcement in VHR is crucial.

 

There is a great deal of variation in the preferences and mesh choices of individual surgeons due to the availability of numerous different types of mesh. Because of their theoretically infection-resistant qualities, which were noted in the early animal model research, biologic meshes are widely utilized.[10,11]

 

Comparing synthetic and biologic mesh in animal investigations, however, revealed that the synthetic mesh exhibited greater neovascularization and bacterial clearance than the biologic mesh.[12] Biologic mesh products have grown in quantity and surgeons are using them more frequently since their launch in the 1990s.Though multiple biologic meshes are available, a systematic research did not find any differences in SSI or recurrence rates among different types of biologic meshes.But given their price, some have questioned the effectiveness of biologic mesh.[13]

 

Though there isn't enough solid evidence to justify biologic mesh's use in VHR, the Ventral Hernia Working Group has supported it as the mesh of choice in high-risk situations. It has been called a potentially useful VHR adjunct[14,15]

 

A previous meta-analysis that mostly included retrospective cohorts with significant heterogeneity found that biologic mesh resulted in fewer infectious wound complications with comparable recurrence rates.[7] More recent case series have resisted this paradigm by using prosthetic materials even in high-risk scenarios like contamination.Using 100 patients with good infection, recurrence, and mesh removal rates, Carbonell et al. presented one of the first studies using synthetic mesh in contaminated instances.[16]

 

Because patients receiving biologic mesh insertion had an unacceptablely high recurrence rate, the non-complex VHR patients in the LAPSIS trial had to end early[15] We omitted patients receiving laparoscopic repairs from our study, even though these patients were initially included in the LAPSIS trial. Biologic mesh had greater rates of recurrence, according to all four RCTs[.5, 8. 15] In a large database analysis involving 2,484 patients with contaminated VHRs, recurrence rates were shown to be 23% for patients with synthetic mesh and 32% for those with biologic mesh following propensity score matching, despite the fact that both studies were conducted by high-volume surgeons.[17]

 

Olavarria et al. discovered a greater incidence of SSIs (15.9% vs. 9.3%) in the biologic group, although it was also not statistically significant. They included 67.8% non-clean patients.

In a large database analysis involving 2,484 patients with contaminated VHRs, recurrence rates were shown to be 23% for patients with synthetic mesh and 32% for those with biologic mesh following propensity score matching, despite the fact that both studies were conducted by high-volume surgeons.[17] ,

 

Only clean-contaminated and contaminated cases were included in Rosen et al's study, which found that the incidence of SSIs was 21.3% in the biological group and 15.1% in the synthetic group. However, this difference was not statistically significant[.5] Olavarria et al. discovered a greater incidence of SSIs (15.9% vs. 9.3%) in the biologic group, although it was also not statistically significant. They included 67.8% non-clean patients.

The placement and material of the mesh can help reduce the impact of prosthetic mesh infection in a synthetic mesh setup. When the mesh is positioned in the extra-peritoneal location, Warren et al. found a mesh salvage rate of up to 72% in the prosthetic mesh infection scenario.[27] Despite the limited total number of mesh explantations in our study, the long-term mesh explantation rate in VHR is roughly 1.5%, with a median interval between transplantations of 208 days.

 

One possible explanation for the good safety profile of synthetic mesh—even in the presence of contamination—is that the majority of patients in our study had open retro-muscular repair using macroporous polypropylene mesh.

Cost-utility evaluations in patients receiving clean-contaminated VHR have also been conducted, and the results indicate that synthetic mesh is more economical than biologic mesh in this context.[29]

 

Synthetic mesh appears to offer not just therapeutic benefits over biologic mesh but also much superior value, which is consistent with the other findings of this study.sea awareness 1

 

The majority of the patients in this study had medium-weight uncoated macroporous polypropylene mesh or porcine acellular dermal matrix mesh, hence the generalizability of our findings to other mesh types may be restricted.

 

In a analysis involving 2,484 patients with contaminated VHRs, recurrence rates were shown to be 23% for patients with synthetic mesh and 32% for those with biologic mesh following propensity score matching, despite the fact that studies were conducted by high-volume surgeons.[17]. It's crucial to emphasize that the all participants were probably treated by experienced surgeons, which may have limited the repeatability of the results.

CONCLUSION

patients having elective VHR who utilize biologic mesh experience a higher rate of SSIs and hernia recurrences than those who use synthetic mesh. There were no variations observed in the rates of mesh removal, hematomas, or seromas. Macroporous uncoated synthetic mesh should be the implant of choice for elective open VHR and should be taken into consideration even in contaminated patients due to the combination of the therapeutic benefit observed in our study and the lower cost.

 

Funding /assistance

No government, private, or nonprofit organization provided any particular funding for this study. There are no disclosures or conflicts of interest for any of the other writers to disclose.

REFERENCES
  1. Mathes T, Prediger B, Walgenbach M, Siegel R (2021) Mesh fxation techniques in primary ventral or incisional hernia Cochrane Database Syst Rev 5:CD011563. https://doi.org/10. 1002/14651858.CD011563.pub2
  2. Pandya B, Huda T, Gupta D, Mehra B, Narang R (2021) Abdomi- nal wall hernias: an epidemiological profle and surgical experi- ence from a rural medical college in central India. Surg J (N Y) 7:e41–e46. https://doi.org/10.1055/s-0040-1722744
  3. Burger JWA, Luijendijk RW, Hop WCJ, et Long-term follow-up of a randomized controlled trial of suture versus mesh repair of incisional hernia. Ann Surg. 2004;240:578e585.
  4. Shankaran V, Weber DJ, Reed RL, Luchette A review of available prosthetics for ventral hernia repair.Ann Surg.2011;253:16e26S.
  5. Rosen MJ, Krpata DM, Petro CC, et Biologic vs synthetic mesh for single-stage repair of contaminated ventral hernias: a randomized clinical trial. JAMA Surg.2022;157:293e301.
  6. 6 Darehzereshki A, Goldfarb M, Zehetner J, et al. Biologic versus non biologic mesh in ventral hernia repair: a systematic review and meta-analysis. World J 2014;38:40e50.
  7. Harris HW, Primus F, Young C, et al. Preventing recurrence in clean and contaminated hernias using biologic versus synthetic mesh in ventral hernia repair: the PRICE randomized clinical trial. Ann Surg. 2021;273
  8. Moher D, Liberati A, Tetzlaff J, Altman Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ. 2009;339
  9. Thorlund K, Imberger G, Johnston BC, et Evolution of heterogeneity estimates and their 95% confidence intervals in large meta-analyses. PLoS One. 2012;7:e39471.
  10. Higgins JPT, Altman DG, Gøtzsche PC, et The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials. BMJ. 2011;343:d5928.
  11. Olavarria OA, Bernardi K, Dhanani NH, et Synthetic versus biologic mesh for complex open ventral hernia repair: a pilot randomized controlled trial. Surg Infect (Larchmt).2021;22:496-503.
  12. Miserez M, Lefering R, Famiglietti F, et Synthetic versus biological mesh in laparoscopic and open ventral hernia repair (LAPSIS): results of a multinational, randomized, controlled, and double-blind trial. Ann Surg. 2021;273:57-65.
  13. Zhou H, Shen Y, Zhang Z, Liu X, Zhang J, Chen Comparison of outcomes of ventral hernia repair using different meshes: a systematic review and network meta-analysis. Hernia. 2022;26:1561
  14. Novitsky YW, Rosen The biology of biologics. Plast Reconstr Surg. 2012;130:
  15. Breuing K, Butler CE, Ferzoco S, et Incisional ventral hernias: review of the literature and recommendations regarding the grading and technique of repair. Surgery. 2010;148
  16. Carbonell AM, Criss CN, Cobb WS, Novitsky YW, Rosen Outcomes of synthetic mesh in contaminated ventral hernia repairs. J Am Coll Surg. 2013;217:991-998
  17. Rodriguez-Quintero JH, Romero-Velez G, Lima DL, Huang L-C, Sreeramoju P,Malcher Permanent vs absorbable mesh for ventral hernia repair in contaminated fields: a multicenter propensity matched analysis of one-year outcomes using the abdominal core health quality collaborative database J Am Coll Surg. doi:10.1097/xcs.0000000000000433. Accessed October 20, 2022.485.
  18. Warren JA, Love M, Cobb WS, et Factors affecting salvage rate of infected prosthetic mesh. Am J Surg. 2020;220:751-756.
  19. Fischer JP, Basta MN, Krishnan NM, Wink JD, Kovach A cost-utility assessment of mesh selection in clean-contaminated ventral hernia repair. Plast Reconstr Surg. 2016;137:647e659.
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