Effect of Amnioguard and Biomesh GTR Membranes with Novabone Putty in the Treatment of Periodontal Osseous Defects-A Communication.

(1) Background: Guided tissue regeneration was an effective surgical procedure in the management of intrabony defects and has undergone a number of changes in terms of materials and techniques. The aim of this study is to compare AmnioGuard and BioMesh in combination with NovaBone putty in intrabony defects. (2) Methodology: Ten patients who needed regenerative periodontal therapy were randomly allocated into two groups based on the inclusion criteria. These patients were subjected to phase I therapy followed by which Group A patients were treated with AmnioGuard + NovaBone putty whereas Group B with BioMesh + NovaBone putty. The clinical indices were obtained at baseline, 3 months and 6 months post-operatively while radiographic parameters were obtained at 6 months post-op. (3) Results & Conclusion: At six months after surgery, Group B (33% bone gain) showed a statistically significant change from Group A (16% bone gain) in both the clinical and radiographic measures (p < 0.05).

BIOLAP: biological versus synthetic mesh in laparo-endoscopic inguinal hernia repair: study protocol for a randomized, multicenter, self-controlled clinical trial.

BACKGROUND: Inguinal hernia repair is one of the most common surgical operations globally; more than 20 million groin herniae are repaired annually worldwide. Recurrence after an inguinal hernia operation is a considerable clinical problem. Another remaining problem after hernia surgery is the occurrence of chronic pain. Up to now, the use of synthetic meshes is the standard procedure, but there is increasing evidence that biological meshes could be advantageous concerning the occurrence of chronic pain due to different postoperative remodeling, without the disadvantages of a life-long implant. We hypothesize that the use of a biological mesh reduces postoperative pain without being inferior in terms of recurrence rate compared with a synthetic mesh. METHODS/DESIGN: The trial compares possible the advantages of biological matrices to synthetic meshes in laparo-endoscopic inguinal hernia repair. Four hundred and ninety-six patients with primary bilateral inguinal herniae in 20 German hernia centers will be enrolled. Biological mesh is used for one of the bilateral herniae, the other side will be operated on with a synthetic mesh. Randomization will preset which side is repaired with which material and trial participants will not be informed about the location of each mesh type. The primary endpoints will be intensity of postoperative local pain and the incidence of recurrent hernia after 2 years. DISCUSSION: There is no reasonably sized trial that assesses the use of biological meshes in laparo-endoscopic inguinal hernia repair. Our self-controlled trial design allows a direct comparison of the two meshes with very few confounding factors as well as minimizing the exclusion criteria. As we compare CE-certified medical devices in their designated indication the medical risk is not different compared to routine clinical care. Due to the common nature of bilateral inguinal hernia, a high recruitment rate is achievable. Because guidelines for hernia repair have stressed the need for reliable data on the already frequent use of biological meshes, we can expect our trial to have a direct implication on hernia-repair standards. TRIAL REGISTRATION: German Clinical Trials Register, ID: DRKS00010178 . Registered on 16.June.2016. BIOLAP underwent full external peer review as part of the funding process with the German Research Foundation.

Effect of varying the crosslinking degree of a pericardial implant with oligourethane on the repair of a rat full-thickness abdominal wall defect.

The stability and bioactivity of biologic implants rely mainly on the control of the crosslinking process of collagen. However, the most common methods have no control on the crosslinking degree producing it excessively. This study outlines the role of crosslinking of collagen-based implants with oligourethane on the host response following reconstruction of a rat full-thickness abdominal wall defect. We decellularized and crosslinked bovine pericardial tissue to achieve two crosslinking degrees. For the decellularized implants, named as non-crosslinked (N-CL), the collagen-amines were 0.42 ± 0.02 mmol/mg. Crosslinking by the oligourethane reduced the primary amine concentration to 0.28 ± 0.01 and 0.19 ± 0.01 mmol/mg; these values were classified as low (∼30%, L-CL) and medium crosslinking (∼50%, M-CL), respectively. By imaging the implants using second harmonic generation microscopy, we observed undulated bundles of collagen fibers organized in multi-directed layers localized in N-CL and L-CL samples. Post-implantation, a negligible change in the organization of collagen fibers in the crosslinked implants was observed, suggesting that the in vivo biodegradation was delayed. An enlargement of the implant area was also observed, without rupture, in all three (N-CL, L-CL, M-CL) materials, whereas adhesion to the omentum, but not to the bowel, was observed. The number of blood vessels after 90-day implantation in N-CL and L-CL was 13 ± 1 and 12 ± 1 per field, respectively, while the number significantly decreased to 2 ± 1 in M-CL. The results suggest that the controlled degree of crosslinking in oligourethane-modified biologic implants can be used as a strategy to balance biodegradation and remodeling in surgical repair of soft tissues.

Transperineal rectocele repair with biomesh: updating of a tertiary refer center prospective study.

PURPOSE: Symptomatic rectocele results in obstructed defecation and constipation. Surgical repair may provide symptomatic relief. A variety of surgical procedures have been used in the rectocele repair to enhance anatomical and functional results and to improve long-term outcomes. METHODS: In this prospective study, we treated 25 selected women suffering from simple symptomatic rectocele with transperineal repair using porcine dermal acellular collagen matrix Biomesh (Permacol®). Watson score and SF-36 questionnaire were used to evaluate postoperative outcomes and quality of life. RESULTS: Follow-up ranged from 12 to 24 months, the mean total Watson score was significantly lower than the preoperative score (P < 0.001), and every patient has improved functional outcomes. There were no major intraoperative or postoperative complications. Two cases of urinary infection and 4 patients delayed wound healing were reported. Those patients who were sexually active prior to surgery have not experienced problems with sexual function or dyspareunia. CONCLUSIONS: Despite lack of comparative study in literature, rectocele repair with Permacol® by the transperineal approach seems an effective and safe procedure that avoids some of the complications associated with synthetic mesh use.

Repair of a Giant Omphalocele in an Infant With a Pericardial Implant Crosslinked With Oligourethane.

The giant omphalocele (GO) represents a challenge for the pediatric surgeon in its management and wall abdominoplasty. Here, we report the outcome of a case in which a GO in a newborn patient was repaired with an implant derived from decellularized bovine pericardium crosslinked with oligourethane. The implantation time was extended for 6 months. This was then followed up by the retrieval of the implant and the subsequent reconstruction in a second surgical time by the closure of the abdominal wall fascia. A short hospital stay, early integration into the patient's family environment, as well as early onset of the oral route without special care of the implant or reconstructed wall nor food restrictions were observed. The reduced presence of the complications described in the literature after application of surgical meshes suggests that this implant can be an effective and safe alternative method in the treatment of abdominal wall defects such as GO.

Characterization of a new decellularized bovine pericardial biological mesh: Structural and mechanical properties.

Implants made from naturally-derived biomaterials, also called biological meshes or biomeshes, typically derive from decellularized extracellular matrix of either animal or human tissue. Biomeshes have many biomedical applications such as ligament repair, bone and cartilage regeneration and soft tissue replacement. Bovine collagen is one of the most widely used and abundantly available xenogenic materials. In particular, bovine pericardium is widely used as extracellular matrix bioprosthetic tissue. The efficiency of a pericardial mesh to function as scaffold depends on the quality of the decellularization protocol used. Moreover, the biomesh mechanical features are critical for a successful surgical repair process, as they must reproduce the biological properties of the autologous tissue. Different methods of physical, chemical, or enzymatic decellularization exist, but no one has proved to be ideal. Therefore, in the present study, we developed a novel decellularization protocol for a bovine pericardium-derived biomesh. We characterized the biomesh obtained by comparing some ultrastructural, physical and mechanical features to a reference commercial biomesh. Quantification revealed that our novel decellularization process removed about 90% of the native pericardial DNA. Microscopic and ultrastructural analysis documented the maintenance of the physiological structure of the pericardial collagen. Moreover, mechanical tests showed that both the extension and resilience of the new biomesh were statistically higher than the commercial control ones. The results presented in this study demonstrate that our protocol is promising in preparing high quality bovine pericardial biomeshes, encouraging further studies to validate its use in tissue engineering and regenerative medicine protocols.

A comparative study of the clinical effects of chitosan nanofiber membrane in the treatment of mandibular class II furcation defects / 대한치주과학회지

The purpose of this study was to evaluate the clinical efficacy of guided tissue regeneration(GTR) technique using chitosan nanofiber membrane and to compare it to the clinical efficacy following GTR using PLA/PLGA(copolymer of polylactic acid and polylacticglycolic acid) membrane in mandibular class II furcation defects in human. The chitosan nanofiber membranes were applied to the mandibular class II furcation defects of 13 patients(test group) and PLA/PLGA membranes were applied to those of 11 patients(control group). Probing pocket depth, clinical attachment level, gingival recession, plaque index and gingival index were measured at baseline and 3 months postoperatively. Vertical and horizontal furcation defect depth were measured at surgery. Both groups were statistically analyzed by Wilcoxon signed Ranks Test and Mann-Whitney Test using SPSS program. The results were as follows: 1. Probing pocket depth, clinical attachment loss and gingival index were significantly reduced at 3 months postoperatively compared to values of baseline in both groups(p<0.05). 2. Gingival recession and plaque index were not significantly decreased at 3 months postoperatively compared to values of baseline in both groups. 3. No significant difference between two groups could be detected with regard to changes of probing pocket depth, gingival recession, clinical attachment level, plaque index and gingival index at 3 months postoperatively. In conclusion, chitosan nanofiber membrane is effective in the treatment of human mandibular class II furcation defects and a longer period study is needed to fully evaluate the outcomes.

A comparative study of the clinical effects of chitosan nanofiber membrane in the treatment of mandibular class II furcation defects / 대한치주과학회지

The purpose of this study was to evaluate the clinical efficacy of guided tissue regeneration(GTR) technique using chitosan nanofiber membrane and to compare it to the clinical efficacy following GTR using PLA/PLGA(copolymer of polylactic acid and polylacticglycolic acid) membrane in mandibular class II furcation defects in human. The chitosan nanofiber membranes were applied to the mandibular class II furcation defects of 13 patients(test group) and PLA/PLGA membranes were applied to those of 11 patients(control group). Probing pocket depth, clinical attachment level, gingival recession, plaque index and gingival index were measured at baseline and 3 months postoperatively. Vertical and horizontal furcation defect depth were measured at surgery. Both groups were statistically analyzed by Wilcoxon signed Ranks Test and Mann-Whitney Test using SPSS program. The results were as follows: 1. Probing pocket depth, clinical attachment loss and gingival index were significantly reduced at 3 months postoperatively compared to values of baseline in both groups(p<0.05). 2. Gingival recession and plaque index were not significantly decreased at 3 months postoperatively compared to values of baseline in both groups. 3. No significant difference between two groups could be detected with regard to changes of probing pocket depth, gingival recession, clinical attachment level, plaque index and gingival index at 3 months postoperatively. In conclusion, chitosan nanofiber membrane is effective in the treatment of human mandibular class II furcation defects and a longer period study is needed to fully evaluate the outcomes.

Guided Bone Regeneration Of Calvarial Bone Defects Using Bioabsorbable Membrane And Demineralized Freeze Dried Bone In Rats

The purpose of this study was to evaluate new bone formation and healing process in rat calvarial bone defects using BioMesh(R) membrane and DFDB. Forty eight rats divided equally into 4 groups of 1 control group and 3 experimental groups. Standardized transosseous circular calvarial defects (8 mm in diameter) were made midparietally. In the control group, the defect was only covered with the soft tissue flap. In the experimental group 1, it was filled with DFDB only, in the experimental group 2, it was covered BioMesh(R) membrane only, and in the experimental group 3, it was filled DFDB and covered with membrane. At the postoperative 1, 2, 4, 8 weeks, rats were sacrificed and histologic and histomorphometric analysis were performed. These results were as follows. In histomorphometric analysis, It showed the greatest amount of new bone formation through experimental in the experimental group 3 (P < 0.001). The amount of new bone formation at the central portion of the defect was greater in the experimental group 3 than experimental group 2. BioMesh(R) membrane began to resorb at 1 week and resorbed almost completely at 8 weeks after operation. The collapse of membrane into the defect was observed through the experimental periods in the experimental group 2. In the area of collapsed membrane, new bone formation was restricted. These results suggest that maintenance of some space for new bone to grow is required in the use of BioMesh(R) membrane alone in the defect. It is also thought that use of the membrane may promote new bone growth in DFDB graft.

Treatment of Class II Furcation Involvements in Humans with Bioabsorbable Guided Tissue Regeneration Barriers / 대한치주과학회지

The purpose of this 6-months study was to compare the clinical and radiographic outcomes following guided tissue regeneration treating human mandibular Class II furcation defects with a bioabsorbable BioMesh barrier(test treatment) or a non-absorbable ePTFE barrier(control treatment). Fourteen defects in 14 patients(mean age 44 years) were treated with BioMesh barriers and ten defects in 10 patients(mean age 48 years) with ePTFE barriers. After initial therapy, a GTR procedure was done. Following flap elevation, root planing, and removal of granulation tissue, each device was adjusted to cover the furcation defect. The flaps were repositioned and sutured to complete coverage of the barriers. A second surgical procedure was performed at control sites after 4 to 6 weeks to remove the nonresorbable barrier. Radiographic and clinical examinations(plaque index, gingival index, tooth mobility, gingival margin position, pocket depth, clinical attachment level) were carried out under standardized conditions immediately before and 6 months after surgery. Furthermore, digital subtraction radiography was carried out. All areas healed uneventfully. Surgical treatment resulted in clinically and statistically equivalent changes when comparisons were made between test and control treatments. Changes in plaque index were 0.7 for test and 0.4 for control treatments; changes in gingival index were 0.9 and 0.5. In both group gingival margin position and pocket depth reduction was 1.0mm and 3.0mm; clinical attachment level gain was 1.9mm. There were no changes in tooth mobility and the bone in radiographic evaluation. No significant(p< or =0.05) difference between the two membranes could be detected with regard to plaque index, gingival index, gingival margin position, pocket depth, and clinical attachment level. In conclusion, a bioabsorbable BioMesh membrane is effective in human mandibular Class II furcation defects and a longer period study is needed to fully evaluate the outcomes.