Amniotic Membrane Allograft Research Articles

Biological Evaluation of a Native Amniotic Membrane Allograft

Category: Basic Sciences/Biologics; Other Introduction/Purpose: Placental tissue allografts have long been used as effective wound dressings for hard to heal wounds and are demonstrating increasing utility in the field of foot and ankle surgeries. Previous observations of the PURION-processed dehydrated amnion/chorion membrane (dHACM) demonstrated retention of regulatory proteins inherent to amniotic tissues and preservation of the bioactivity to stimulate cellular activities. Novel and patent-pending processing techniques have been developed to introduce a thicker and more robust allograft, as compared to dHACM. Lyophilized human amnion chorion membrane (LHACM) will confer versatility to clinicians with improved handling while maintaining the natural tissue composition and intrinsic biological activities. This study characterizes the biological properties of LHACM which may support the healing cascade. Methods: LHACM was processed using a modified PURION process which incorporates an optimized cleansing process, enabling retention of the intermediate layer, and lyophilization. Tissue architecture was visualized with hematoxylin and eosin staining. The hygroscopic contribution of the intermediate layer was appraised with absorbency measurements. Cleansing efficiency was determined through quantification of residual hemin remaining in the tissue. Regulatory proteins were quantified using a multiplex ELISA. The cellular response to LHACM treatment was assessed using multiple in vitro assays targeting cellular proliferation and analysis of signaling pathways. Adult dermal fibroblasts (HDFs) cultured over a 3-day period in LHACM eluates were assessed for cellular proliferation. In vitro models were developed to assess the regulation of relevant signaling pathways, including TGF-β1 and Wnt/β-catenin for fibrotic and proliferative processes, respectively. Cellular responses were evaluated through quantitative PCR and cell reporter lines. Results: Histological evaluation showed that processing maintains the tissue structure. Absorption testing demonstrated LHACM is more hygroscopic than dHACM. Hemin analysis demonstrated low levels of residual hemin which were comparable for LHACM and dHACM allografts. Screening for regulatory proteins indicate that LHACM contains a diverse array of regulatory proteins, inherent to amniotic membranes. In vitro treatment of primary cells with LHACM eluates promoted dermal fibroblast proliferation as well as regulation of elevated TGFβ- and Wnt/β-catenin signaling. Conclusion: The processing method of LHACM maintains the intrinsic properties of amniotic membranes with similar levels of biological activity as compared to dHACM, while providing an option for a thicker allograft with alternative handling characteristics. LHACM represents a novel product concept which increases versatility of amniotic membrane application in varied outpatient and surgical uses.

Application of Dehydrated Amniotic Membrane Allografts in Advanced Diabetic Foot Ulceration: Case Report and Review of Literature

The management of diabetic foot ulcers (DFUs) presents challenges to even the most experienced wound-care providers. Because of the chronic, non-healing nature of many DFUs, advances in the treatment and care of this disease process are particularly relevant. This case study aims to report the efficacy of the application of dehydrated amniotic membrane allograft (DAMA) to a diabetic foot ulcer. The patient in this study is a 44-year-old male who presented with an aggressive infection on his right foot, which resulted in an open wound of 18-month duration. This patient received weekly applications of dual-layer DAMA over seven weeks. Upon examination at the initial application, the wound was classified as a Wagner grade 3 with necrosis of the underlying muscle. Upon inspection at the final visit, the wound was closed entirely. The results that were shown include improvements in the size, depth, edges, necrotic tissue amount, and epithelization of the wound. This case study demonstrates that the application of DAMA has the potential to augment the body’s natural DFU healing response; however, future nonrandomized and randomized controlled trials are needed to establish its efficacy further.

USE OF THE HUMAN PLACENTA IN THE HEALING OF FOOT ULCERS IN PEOPLE WITH DIABETES: INTEGRATIVE REVIEW

Objective: To identify in the literature the contributions of the use of the human placenta in the healing of foot ulcers in people with diabetes. Method: An integrative review study carried out by searching articles in Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS), Scientific Electronic Library Online (SciELO), Cumulative Index to Nursing and Allied Health Literature (CINAHL), Cochrane Library, National Library of Medicine (PubMed), Web of Science and Scopus, using the search strategies: Placenta AND “Diabetic foot” and Placenta AND “Diabetic Foot”. Results: The initial search resulted in 148 articles. After applying the inclusion and exclusion criteria, a final sample of 12 articles was obtained. It was observed that the placenta has the potential to promote the improvement of granulation tissue and peripheral circulation, greater epithelialization, and reduction in the wound area, with the majority use of cryopreserved placental and amniotic membrane allograft. Conclusion: The human placenta is a nutrient-rich biological material that has the potential to contribute to the tissue repair of foot ulcers in people with diabetes in a shorter period of time.

Healing hard-to-heal diabetic foot ulcers: the role of dehydrated amniotic allograft with cross-linked bovine-tendon collagen and glycosaminoglycan matrix.

The treatment of diabetic foot ulcers is complex and costly with an increased risk for infection, which may even lead to amputation. This prospective case series aims to assess the effectiveness of a dehydrated amniotic membrane allograft combined with a bilayer dermal matrix for healing complicated foot ulcers in patients with comorbidities. A total of six patients with complicated full-thickness ulcers and comorbidities, such as diabetes and peripheral vascular disease were treated with this technique. Each wound was measured intraoperatively just before graft application, at 14 days after application, and then at weeks 4, 8, and 12. Changes in wound volume and area were compared over time. One patient had complete wound closure by week eight, a second patient by week 12. The other four patients had wounds that decreased in size during the course of 12 weeks. The mean decrease in wound volume was 73.5% post-removal of the bilayer dermal matrix after two weeks of application. At week 12, the mean decrease in wound area and volume were 93.2% and 97.1%, respectively. This case series provides initial evidence that the combination of dehydrated amniotic membrane allograft with bilayer dermal matrix promotes complete wound closure in patients with comorbidities that may impede wound healing. Further clinical trials are needed to confirm these results.

83 Dehydrated human amniotic membrane and amniotic fluid for the treatment of rectovaginal fistulas

The presence of a rectovaginal fistula (RVF) can be devastating to patients thus greatly affecting their quality of life. The most common etiologies of RVF are those resulting from obstetric complications, pelvic radiation, malignancy, infection, and postoperative complications. The treatment of RVF is mainly surgical; however, current techniques still have a high rate of recurrence. Our objective is to present a novel surgical technique with the use of a dehydrated amniotic membrane (VendajeTM) and an amniotic suspension allograft (RheoTM) in repair of rectovaginal fistula. Two cases of chronic rectovaginal fistula were seen in the urogynecology office. Informed consent was obtained to proceed with surgical repair using the dehydrated amniotic membrane and amniotic suspension allograft. Under general anesthesia, the RVF fistula repair was done by first using a #5 silk suture that was threaded back and forth in the fistula tract to de-epithelialize the tract and uncover healthy tissue (Figure 1). The rectal side of the fistula tract was closed with 3-0 vicryl interrupted sutures. The amniotic membrane was soaked in 1 mL of the amniotic suspension before being placed into the fistula tract from the vaginal side. The vaginal side of the tract was reapproximated with 3-0 vicryl interrupted sutures (Figure 2). Finally, the remainder of the amniotic suspension was injected into the tract. The patients were also advised to use estrace vaginal cream to promote wound healing and increase blood supply to the surgical site. One case of complete resolution (5 mm to closure) of rectovaginal fistula and one case of 90% improvement (1cm to 1mm) of fistula is presented utilizing a novel therapeutic approach with the amniotic membrane pre-soaked in an amniotic suspension allograft followed by injection of remaining allograft into the fistula tract. This novel application of dehydrated human amniotic membrane allograft and amniotic suspension allograft is an effective therapy for chronic rectovaginal fistula. This procedure also highlights the importance of the complexity of the fistula and health of the supporting tissue prior to fistula repair seen in the case with 70% improvement.

Systematic review on the rational use of amniotic membrane allografts in diabetic foot ulcer treatment

BackgroundDiabetic foot ulcer is a complication with multiple aetiological factors which has a significant impact to patients’ lives and costs to the healthcare system. The potential of human amniotic membrane to act as an allograft has been studied in relation to this condition. Aim of this study is to evaluate the current scientific evidence on its effectiveness in healing diabetic foot ulcers.MethodsPubmed, Cochrane library, and Google scholar were searched using the search terms, “Amnion” OR “Placenta” AND “Diabetic foot”. (MeSH terms) in the title or the abstract field from 1st of January 2000 to 30th March 2020. The quality of published reports was assessed using standard methods. We searched for experimental and observational studies in terms of randomized control trials, prospective cohort, retrospective cohort studies and case series.ResultsWhen searched with Mesh terms, 12 citations in PubMed, 22 citations in Cochrane library and 30 in other data bases were found. After screening the studies and their reference lists, 12 studies met the inclusion criteria and the others were excluded. There were 8 randomized control trials (RCTs), 2 prospective studies and 2 retrospective studies employing different preparation methods of the amniotic membranes. A wide variation in study end points were noted. Majority of the RCTs (n = 7) were concluded with significantly higher wound closure rate compared to the conventional treatment groups. In prospective and retrospective studies, it was shown that large chronic ulcers which were resistant to closure with standard therapy achieved wound closure with amniotic membrane allografts. A meta-analysis could not be performed due to study heterogeneity, and publication bias was not assessed due to the small number of available studies which was not sufficient for accurate comparison.ConclusionEven though, the studies had some inherent heterogeneity due to different preparation methods, different study end points and outcome measurements. According to our review the current studies using amniotic membrane allografts give reliable evidence of reduction in healing time over conventional methods.

Flowable Dehydrated Amniotic Membrane Allograft Augments McDonald Cerclage in High-Risk Women for Preterm Birth Prevention, a Case Series

The inability of the uterine cervix to retain a pregnancy in the second trimester is referred to as cervical insufficiency. The most common intervention for such cervical insufficiency to prevent preterm birth is a McDonald cerclage. However, the rate of success ranges from 40-90%. This 3 patient case series is the first report of supplemental use of a dehydrated amniotic membrane allograft (DAMA; BioDRestore®) at the cerclage suture sites as a means to improve success, measured by prevention of pre-term birth, reduction in complications of neonatal prematurity, and decreased length of hospitalization for mother and neonates.

Early Advanced Therapy for Diabetic Foot Ulcers in High Amputation Risk Veterans: A Cohort Study.

Veterans with diabetic foot ulcers (DFUs) represent the highest percentage of lower extremity amputations (LEAs) within the Veterans Affairs (VA) population. Many veterans have additional risk factors for amputation. Few studies focus on advanced therapies for this population. This study explores the impact of early application of dehydrated human amniotic membrane allograft (DAMA) with comprehensive care on preventing amputation. This prospective, single-center cohort study (ClinicalTrials.gov Identifier NCT02632929) was conducted through Boise VA Medical Center. Patients with DFUs were objectively stratified for LEA risk. Those with moderate to high amputation risk could participate. Participants received comprehensive care and weekly application of DAMA. Primary endpoint was avoidance of major LEA. Secondary endpoint was wound epithelialization. Monitoring continued 4 months. Between July 2015 and March 2017, 20 patients (mean age 67.2 years) with 24 DFU classified as moderate (12 wounds) to high risk (12 wounds) for amputation were enrolled. Wound volumes ranged from 0.072 cm3 to 56.4 cm3. Risk factors included neuropathy (20 patients), osteomyelitis (16 wounds), exposed tendon/ligament/bone (19 wounds), Charcot (5 patients), and peripheral arterial disease (13 wounds). All subjects avoided amputation within the study period, all 24 wounds achieved re-epithelialization within 4 to 33 weeks; mean healing time 13.2 weeks. Cost for the DAMA tissue ranged from $750 to $38 150. Estimated cost for LEA ranges from $30 000 to $50 000. No treatment-related adverse events during the study period were reported. The results suggest that early and frequent application of DAMA with comprehensive care may help prevent amputation. Additional research will help inform third-party payors and clinicians.

Biological characterization of dehydrated amniotic membrane allograft: Mechanisms of action and implications for wound care.

There is a growing clinical demand in the wound care market to treat chronic wounds such as diabetic foot ulcers. Advanced cell and tissue-based products (CTPs) are often used to address challenging chronic wounds where healing has stalled. These products contain active biologics such as growth factors and cytokines as well as structural components that support and stimulate cell growth and assist in tissue regeneration. This study addresses the in vitro biologic effects of a clinically available dehydrated amniotic membrane allograft (DAMA). The broad mechanism of action results from DAMA's biologic composition that leads to stimulation of cell migration cell proliferation, and reduction of pro-inflammatory cytokines. Results show that DAMA possesses growth factors and cytokines such as EGF, FGF, PDGFs, VEGF, TGF-β, IL-8, and TIMPs 1 and 2. Furthermore, in vitro experiments demonstrate that DAMA stimulates cell proliferation, cell migration, secretion of collagen type I, and the reduction of pro-inflammatory cytokines IL-1β, IL-6, and TNF-α. This study findings are consistent with the clinical benefits previously published for DAMA and other CTPs in chronic wounds suggesting that the introduction of DAMA to non-healing, complex wounds helps to improve the wound milieu by providing essential structural components, cytokines, and growth factors to create an appropriate environment for wound healing.

Use of human amniotic membrane repair of anterior urethral defect: First clinical report.

To evaluate the use of human amniotic membrane allograft to prevent urethrocutaneous fistula after tubularized incised plate repair for redo-hypospadias and anterior urethral defects. This pilot study included 28 patients (mean age 25.3±11years) with a history of previous failed hypospadia repair, who underwent tubularized incised plate urethroplasty in one session by the same surgical team from April 2016 to April 2019. After the reconstruction of a neourethra and proper hemostasis, a human amniotic membrane allograft - Grafting Scaffold - was used to cover the suture lines. The mean follow-up time was 13.3±4.5months. Two urethrocutaneous fistulas occurred within the first 2weeks after the surgery, one of which was caused by the infection of the surgical site. No penile torsion, urethral diverticula, meatal stenosis or glans dehiscence was reported. Amniotic membrane graft provides an applicable, low-cost, feasible, biodegradable and safe second cover in redo-hypospadias repairs by tubularized incised plate technique. Its use is technically easy; it has satisfactory cosmetic outcomes and might decrease urethrocutaneous fistula formation.

Human amniotic membrane allograft, a novel treatment for chronic diabetic foot ulcers: A systematic review and meta-analysis of randomised controlled trials.

To evaluate the efficacy and safety of human amniotic membrane (HAM) allograft in treating chronic diabetic foot ulcers (DFUs), a comprehensive search of randomised controlled trials in MEDLINE, EMBASE, PubMed, CENTRAL and Web of Science was conducted to December 7, 2019. Two reviewers independently screened the studies, extracted data, and evaluated the quality of studies. The primary outcome was the proportion of complete healing. The secondary outcomes were mean time to complete healing and adverse events. Statistical analyses were performed using RevMan 5.3. We identified 257 articles, of which 7 articles (465 participants) were included in the meta-analysis. The proportion of complete wound healing in HAM plus standard of care (SOC) group was 3.88 times as high as that in SOC alone (RR: 3.88 [95% CI: 2.34, 6.44]) at 6 weeks, and 2.01 times at 12 weeks (RR: 2.01 [95%CI: 1.45, 2.77]). The intervention group had a significantly shorter time to complete healing (MD: -30.33 days, [95% CI: -37.95, -22.72]). The number needed to treat within 6 weeks was 2.3 ([95% CI: 1.8, 3.1]). No significant difference was shown in adverse events. Results were consistent in a sensitivity analysis. Hence, HAM plus SOC is effective and safe in treating chronic DFUs.

Utility of Dehydrated Human Amniotic Membrane (DHAM) in Total Ankle Arthroplasty.

Wound complications after total ankle arthroplasty (TAA) are a common postoperative complication occurring in 14% to 66% of all surgeries. Soft tissue breakdown along the anterior incision can cause exposure of anterior tendons and implant, and adhesions of the extensor tendons of the foot. Recent publications have advocated for the implantation of dehydrated human amniotic membrane (DHAM) allograft during closure of anterior ankle incisions during TAA. The goal of this study was to determine whether implantation of DHAM allograft in TAAs decreased overall postoperative wound complications. One hundred seventy patients with end-stage ankle arthritis refractory to conservative management underwent TAA with a standard anterior approach by 1 of 3 board-certified foot and ankle orthopedic surgeons. Ninety-one patients underwent closure of the anterior incision with addition of DHAM, whereas 79 patients served as the control (no addition of DHAM). The primary endpoints considered were postoperative complications and reoperation. Included in the postoperative complications was return to the operating room, postoperative plastic surgery intervention, wound communication with the implant, removal of the implant, neurolysis, tendon debridement, and extensor hallucis longus contracture/adhesions. In the analysis of our demographically homogenous cohorts, there was no statistically significant difference in any postoperative complications between patients closed with DHAM and controls. Return to the operating room occurred in 8.9% of controls and 15.4% of the DHAM group (P = .291). Similarly, there was no statistically significant difference in postoperative plastic surgery, wound communication with the implant, implant removal, neurolysis, and tendon debridement between the control and DHAM groups. The application of DHAM theoretically acts to decrease overall wound complications in TAA. The use of DHAM preceding wound closure in TAA did not show a statistically significant reduction in overall wound complications in our retrospective analysis. Further study, including prospective randomized studies, is needed to further investigate the effectiveness of DHAM in reducing wound complications in TAAs. Level III, retrospective cohort study.

Gamma-treated placental amniotic membrane allograft as the adjuvant treatment of unresponsive diabetic ulcer of the foot

IntroductionDiabetic ulcer of the foot is a major cause of morbidity and is a leading cause of hospitalization in patients with diabetes, and causes productivity and financial losses that lower the quality of life of the patient. The wound is categorized as responsive and unresponsive wound, which occurs in debilitated patients as seen in diabetes mellitus. The delay in wound repair can be caused by senescent cells, absence of growth factors, and other cellular abnormalities. MethodThis is a retrospective, single-centre case series with non-consecutive cases. Patients with diabetic ulcer of the foot managed using gamma-treated placental amniotic membrane, with the minimum follow up of 1 month in academic practice setting were recruited. ResultThree patients with 4 weeks period of oozing ulcers and signs of inflammation were included in this case series. Two layers of amniotic membrane dressing was applied weekly after cleaning and debridement for 3 weeks. Wound size and secretion were documented by taking photographs every week. At the end of the third week, the wound healed. DiscussionPlacental amniotic membranes are composed of cells, extra-cellular matrix (ECM), and a complex of regulatory cytokines which promote cell proliferation, cell modulation, and cytokine secretion by variety of cell types involved in wound healing. Our study showed that the treatment of diabetic ulcer wound using amniotic membrane was successful in achieving wound healing in unresponsive, chronic wound of diabetic ulcer of the foot. ConclusionOur results clearly indicated the usefulness of the application of amniotic membranes in treatment of diabetic ulcer of the foot. Amniotic membrane favoured healing of unresponsive and non-healing ulcers.

Clinical, Radiographical and Histopathological Evaluation of Amniotic Membrane Allograft Pulpotomy in Primary teeth

Background: A novel dehydrated Human Amniotic Membrane (dHAM) allograft is a placental based scaffold that has been widely used in a verity of medical fields due to its unique regenerative ability in wound healing. Objective: To evaluate clinically, radiographically, and histopathologically the efficacy of dehydrated Human Amniotic Membrane allograf as a pulpotomy agent in primary teeth. Materials and Methods: I- Clinical and radiographical evaluation: This split-mouth, randomized clinical trial was conducted on 40 deeply carious primary molars indicated for pulpotomy. They were selected from 16 healthy children aged 4-8 years. They were randomly allocated into two equal groups (20 molars/each). Group 1: dHAM pulpotomy in one quadrant and Group 2: Formocresol (FC) pulpotomy in the contralateral. All molars were treated with the conventional pulpotomy technique. All patients were recalled for clinical and radiographical evaluation at 3, 6, and 9 months post-treatment. II- Histopathological assessment: A total of 30 healthy lower first primary molars and canines that indicated for serial extraction were selected for histopathological evaluation. The dHAM allograft and formocresol pulpotomies were performed (12 teeth/each group), where the other 6 teeth were used as a control. Six teeth from each experimental group were extracted at post-treatment intervals; one and three months. The samples were prepared for histopathological evaluation. All data were subjected to the exact test. Fisher exact test and Monte Carlo test were also used. The level of significance was set at P 0.05). II-Histopathological results: The overall evaluation at 1-month interval showed better histopathological criteria for dHAM group than FC group, but the difference was only significantly better on the degree of the inflammatory response (p<0.05). Whereas at 3-month interval, the dHAM group displayed significantly better histopathological criteria compared to the FC group (p<0.05). Conclusion: The dHAM allograft with its regenerative, biologic biocompatibility properties and its ability to deliver growth factors has shown successful outcome comparable to gold standard formocresol. Hence, it can be recommended as an alternative promising pulpotomy agent.

Review of Use of Amniotic Membrane Allograft in Total Ankle Replacements

Category:Ankle ArthritisIntroduction/Purpose:Wound complications after total ankle replacement (TAR) lead to increased postoperative morbidity with lasting consequences. Previous studies demonstrate delayed wound healing in 6.6% to 28% of all TARs. Soft tissue breakdown along the anterior incision can cause exposure of anterior tendons and the implants. In addition, adhesions of the extensor tendons can develop causing significant morbidity. Recent publications advocate for the use of dehydrated human amnion/chorion membrane allograft (dHACM) during closure of anterior ankle incisions during TAR. dHACM is shown to promote increased epithelial cell proliferation, recruitment, and differentiation and reduce the likelihood of tendon adhesions. The goal of this study was to review the use of dHACMs in TARs and to investigate the number and type of postoperative wound complications including extensor tendon adhesions.Methods:We retrospectively reviewed 92 TARs performed between April, 2016 through August, 2018 by two board certified, fellowship trained foot and ankle orthopaedic surgeons. A standard anterior approach was done in all cases. All TARs had dHACM graft placed deep to the tibialis anterior and extensor longus tendon and along the extensor retinaculum prior to final closure of the wound. Upon data review, we identified the subset of patients who had anterior wound dehiscence postoperatively requiring an additional procedure(s) for wound coverage. We compared the demographics, medical comorbidities, and operative characteristics of those with and without perioperative wound complications.Results:12 patients who underwent TARs sustained wound dehiscence below the subcutaneous tissue and required operative intervention (13%). Of these 12 cases, 5 required bipedical or rotational fasciocutaneous flap coverage (5.4%), 6 required less extensive soft tissue surgery (6.5%) and one case involved a deep periprosthetic infection that resulted in explant and antibiotic spacer placement (1.1%). 6 of the 12 cases required a split thickness skin graft application (6.5%) and 2 cases required tenolysis of extensor tendon adhesions (2.2%). Normal excursion of extensor tendons was seen in 90 patients (97.8%). Except for the one infected ankle, there were no cases with wound dehiscence that communicated with the joint. There were no statistically significant differences in medical comorbidities/operative characteristics between patients with wound complications and those without.Conclusion:Wound complications after total ankle replacements often lead to poor long-term outcomes for patients. Our data suggests that the application of the amniotic membrane allograft and its inherent healing potential decreases postoperative tendon adhesions and significant wound dehiscence. This may lead to less deep wound infections that communicate with the joint and may be protective against total ankle replacement failures due to these complications.

Effects of acellular equine amniotic allografts on the healing of experimentally induced full-thickness distal limb wounds in horses.

To characterize the growth factors contained in equine amniotic membrane allograft (eAM; StemWrap scaffold and StemWrap+ injection) and to evaluate the effect of eAM on equine distal limb wound healing. Prospective experimental controlled study. Eight adult horses. Transforming growth factor (TGF)-β1, vascular endothelial growth factor (VEGF), epidermal growth factor, platelet-derived growth factor-BB, and prostaglandin E2 (PGE2 ) concentrations in StemWrap+ were assessed with enzyme-linked immunosorbent assay. Two full-thickness 6.25-cm2 skin wounds were created on each metacarpus. On one forelimb, one wound was treated with eAM, and the other was left untreated (eAM control). On the contralateral limb, one wound was treated with a silicone dressing, and the other served as negative control. Three-dimensional images were obtained to determine wound circumference and surface area analyses at each bandage change until healed. Excessive granulation tissue was debrided once weekly for 4 weeks. Biopsy samples were taken to evaluate quality of wound healing via histologic and immunohistochemistry assays. StemWrap+ contained moderate concentrations of TGF-β1 (494.10 pg/mL), VEGF (212.52 pg/mL), and PGE2 (1811.61 pg/mL). Treatment of wounds with eAM did not affect time to healing or histologic quality of the healing compared with other groups but was associated with increased granulation tissue production early in the study, particularly on day 7. Application of eAM resulted in increased granulation tissue production while maintaining appropriate healing of experimental wounds. Use of eAM is likely most beneficial for substantial wounds in which expedient production of large amounts of granulation tissue is desirable.

The use of dehydrated amniotic membrane allograft for augmentation of dural repair in transsphenoidal endoscopic endonasal resection of pituitary adenomas.

In transsphenoidal endoscopic endonasal surgery (TEES), watertight separation of the sinonasal cavity and intracranial compartment is the primary goal of closure. However, even when meticulous closure technique is implemented, cerebrospinal fluid (CSF) leaks, dural scarring, and meningitis may result. Particularly when intraoperative CSF leak occurs, materials that facilitate the creation of a watertight seal that inhibits disease transition and minimizes inflammatory response after durotomy are sought. Dehydrated amniotic membrane (DAM) allograft appears to confer these attributes as studies have shown it augments epithelialization, facilitates wound healing, and minimizes and impedes bacterial growth. We detail the use of DAM allograft to augment sellar closures after TEES. We conducted a feasibility study, retrospectively reviewing our institution's database of TEES for resection of pituitary adenomas in which DAM was utilized to supplement sellar closure. One hundred twenty transsphenoidal surgery cases with DAM were used during sellar closure, with a 49.2% intraoperative CSF leak rate. Of this cohort, two patients experienced postoperative CSF leak (1.7%), and no patients developed meningitis. CSF leak rate for TEES-naïve patients was 0.9%. This feasibility study demonstrates that dehydrated amniotic membrane allograft can be safely utilized as an adjunct during sellar closures for TEES for pituitary adenoma resection with very low rates of CSF leak and meningitis.

A matched and controlled longitudinal cohort study of dehydrated human amniotic membrane allograft sheet used as awraparound nerve bundles in robotic-assisted laparoscopic radical prostatectomy: a puissant adjunct for enhanced potency outcomes.

We sought to explore the potency outcomes in two systematically controlled, non-randomized, matched, homogenous patient cohorts, which either underwent intervention (INT) with placement of dehydrated human amniotic membrane (dHAM) around nerve bundles (NVB) during robotic-assisted laparoscopic radical prostatectomy (RALP) or did not (CON). It is hypothesized that dHAM use would lead to better potency outcomes. 1400 eligible informed, consented patients underwent full bilateral nerve-sparing RALP by a single surgeon, wherein 700 patients had dHAM allograft wrapped around the NVB and 700 did not. Groups were matched demographically, clinically, and biochemically. Potency was defined as the ability to have satisfactory penetrative intercourse > 50% of time with SHIM score of ≥ 17 with or without of phosphodiesterase-5 inhibitors. A retrospective matched longitudinal cohort study was performed at 1year. The first noticeable erection sufficient enough for a satisfactory penetrative intercourse was significantly earlier (p < 0.01; 34.6 ± 3.6days), whereas the decrease in SHIM score was lower (4.27 ± 0.14days) in INT. Binary logistic regression demonstrated that INT was an independent significant (p < 0.001) predictor of achieving potency at 1year, such that INT was 3.86 times (95% CI 2.43-6.13) more likely to achieve potency in the same period when compared with CON. Chi square analysis demonstrated that recovery of potency in INT was better (p < 0.05) in every quarter compared to CON. A higher (p < 0.005) percentage (93.1%) of INT regained potency versus CON (87.1%) at 1year.

The use of dehydrated amniotic membrane allograft for augmentation of dural closure in craniotomies and endoscopic endonasal transphenoidal surgeries

Background: Primary watertight dural closure is the preferred method of postcraniotomy dural repair. However, even when ideal technique is implemented, postoperative infection, cerebrospinal fluid (CSF) leaks, pseudomeningoceles, and dural scarring are possible complications. For this reason, materials that augment the dura’s ability to create a watertight seal, prevent disease transmission, and inhibit inflammatory response are sought. Dehydrated amniotic membrane (DAM) allograft appears to fulfil these requirements as it has several beneficial properties that aid wound healing, including promotion of epithelialization, scar tissue prevention, and inhibition of bacterial growth. We provide the literature’s first description of the use of DAM allograft to supplement dural closures for craniotomies and transsphenoidal surgeries.Methods: We conducted a pilot study, retrospectively reviewing our institution’s database of craniotomies and transsphenoidal surgeries that utilized DAM to augment dural closure.Results: One hundred fifty-five cases, including 102 new craniotomies for supratentorial lesions, one re-do craniotomy for supratentorial recurrent glioma, 18 craniotomies for infratentorial lesions, 1 craniotomy for anterior skull base schwannoma, 32 transphenoidal surgeries, and 1 combined craniotomy and transnasal endoscopic surgery, used DAM allograft to augment dural closure. Only one complication occurred (0.6% complication rate), which was a superficial wound infection requiring washout without craniectomy. No CSF leaks occurred.Conclusions: This pilot study demonstrates that dehydrated amniotic membrane allograft can be safely utilized as an adjunct during dural closures for craniotomies and transsphenoidal surgeries.

The Use of Dehydrated Amniotic Membrane Allograft for the Augmentation of Dural Repair in Craniotomies.

Background: In cranial neurosurgery, primary watertight dural closure is the standard method of post-craniotomy dural repair. However, cerebrospinal fluid (CSF) leaks, pseudomeningoceles, postoperative infections, and dural scarring are possible complications, even when a meticulous technique is implemented. For this reason, materials that enhance the dura’s ability to create a watertight seal, inhibit the inflammatory response, and prevent disease transmission are sought. Dehydrated amniotic membrane (DAM) allograft appears to facilitate these properties, as studies have shown that it improves wound healing, prevents scar tissue formation, promotes epithelialization, and inhibits bacterial growth. We detail the use of a DAM allograft to augment dural closures for craniotomies.Methods: We conducted a pilot study, retrospectively reviewing our institution’s database of craniotomies that utilized DAM to supplement dural closure.Results: A total of 122 cases, including 18 initial craniotomies for infratentorial lesions, 102 initial craniotomies for supratentorial lesions, one re-do craniotomy for supratentorial recurrent glioma, and one craniotomy for an anterior skull base schwannoma used a DAM allograft to augment dural closure. Only one complication occurred (0.8% complication rate), which was a superficial wound infection requiring washout without craniectomy. No CSF leaks occurred.Conclusions: This pilot study demonstrates that dehydrated amniotic membrane allograft can be safely utilized as an adjunct during dural closures for craniotomies.