Management of grade II and III furcation defects with intramarrow penetration along with indigenously prepared DFDBA and amniotic membrane: a clinical and radiographic study.

Managing furcation defects constitutes a problem in successful periodontal therapy. Guided tissue regeneration (GTR) is the mainstay for the management of such defects but is expensive. This study makes use of indigenously prepared demineralized freeze-dried bone allograft (DFDBA) and amniotic membrane (AM) as a cost-effective alternative. The purpose of the study was to compare the clinical outcome of grade II and III furcation defects with and without using indigenous DFDBA and AM prepared at Central Tissue Bank, MAIDS. 18 systemically healthy patients with chronic periodontitis displaying either grade II or III furcation defects were treated with open flap debridement (OFD) + intramarrow penetration (IMP) (control group) and OFD + IMP + DFDBA + AM (test group). The clinical and radiographic parameters were recorded at 3 and 6 months postoperatively. All parameters were statistically analyzed. Both treatment modalities resulted in improvement in all clinical variables evaluated. Radiographic dimensions evaluating bone fill showed a statistically significant difference in the test group compared to the control group. Within the limitations of this study, data suggest GTR using indigenously prepared DFDBA and amniotic membrane to be an economical and viable option for treating furcation defects.

Dehydrated human amnion/chorion membrane allograft with spongy layer to significantly improve the outcome of chronic non-healing wounds.

We investigated the healing effect of a new dehydrated amnion/chorion membrane with a spongy layer over a 30-month period in 32 patients with 53 chronic non-healing wounds of different aetiologies. Wounds with <40% surface reduction after 4 weeks of best wound treatment underwent weekly allograft application by a certified wound specialist based on national guidelines and a standardised protocol until complete healing or definite treatment interruption. The main outcome measure was the percentage of wound surface reduction from baseline calculated using digital planimetry follow-up photographs. Overall, 38 (71.7%) wounds presented a favourable outcome (70%-100% area reduction), with 35 (66%) completely healing over a median time of 77 days (range 29-350 days). Favourable outcomes were observed in 75% of traumatic wounds, surgical wounds, venous leg ulcers and pressure injuries, as well as in 50% of ischaemic wounds. Wounds being present <12 months were significantly more likely to have a favourable outcome than more long-standing wounds (χ2 = 7.799; p = 0.005; OR = 3.378; 95% CI, 1.410-8.092). Thus, treatment with dehydrated amnion/chorion membrane with a spongy layer improves the outcome of non-healing wounds of different aetiologies and, therefore, has to be considered early in the management of refractory wounds.

Sutureless Dehydrated Amniotic Membrane (Omnigen) Application Using a Specialised Bandage Contact Lens (OmniLenz) for the Treatment of Dry Eye Disease: A 6-Month Randomised Control Trial.

Background and Objectives: Dry Eye Disease (DED) is a chronic condition characterised by tear film instability and ocular surface disruption, significantly impacting patients' quality of life. This study aimed to provide top-level clinical evidence for the long-term efficacy of dehydrated amniotic membrane (dAM, Omnigen®) delivered via a specialised bandage contact lens (sBCL, OmniLenz) for managing moderate-to-severe DED. Materials and Methods: This randomised controlled trial (NCT04553432) involved 93 participants with moderate-to-severe DED, randomised to receive a 1-week bilateral treatment of either dAM (17 mm diameter with 6 mm central 'window') applied under a sBCL or sBCL alone. Participants were assessed at baseline and followed up at 1, 3, and 6 months post-treatment. Outcomes included changes in symptomatology, tear film and ocular surface measurements, and in vivo confocal microscopy imaging of corneal nerve parameters and corneal dendritic cell (CDC) counts. Results: The dAM-sBCL group demonstrated a 65% reduction in OSDI scores at 6 months (p < 0.001), with 88% of participants showing improvement at 1 month. Corneal staining was significantly reduced in both groups. dAM-sBCL provided significant improvements in corneal nerve parameters at 1 month, with sustained positive trends at 3 months. Additionally, dAM-sBCL significantly reduced mature CDC counts, suggesting an anti-inflammatory effect. Conclusions: Treatment with dAM-sBCL for just 1 week significantly and rapidly improved dry eye symptoms as well as ocular surface signs for at least 3 months. It also enhanced corneal nerve health while reducing activated/mature corneal inflammatory cell numbers, presenting a safe and promising new treatment for moderate-to-severe DED.

Unique Usages of Dehydrated Human Amnion Chorion Membrane Allografts in Dermatology.

Dehydrated human amnion chorion membrane (dHACM) allografts are synthetic skin substitutes derived from placental tissue. dHACM allografts are used for replacing lost or damaged dermal tissue, as they contain many of the components found within the extracellular matrix that are beneficial in wound healing. Common uses of dHACM allografts include the healing of diabetic and non-diabetic foot and leg ulcers, decubitus ulcers, and wounds following debridement. While these grafts have been proven to be beneficial in other disciplines of medicine, their potential for use in the field of dermatology is emerging. Current clinical cases and research have shown dHACM allografts to be beneficial in repairing damaged tissue due to dermatologic conditions. They could play a role in the treatment of conditions causing chronic wounds, including dermal scarring or loss, and the repair of fragile skin. Examples of dHACM allograft use in dermatology include cases of pyoderma gangrenosum, Netherton syndrome, and wound healing with Mohs micrographic surgery. This literature review explores the efficacy of using dHACM allografts for the treatment of healing wounds within the field of dermatology. J Drugs Dermatol. 2023;22(12):1228-1231. doi:10.36849/JDD.7115.

Wound repair, safety, and functional outcomes in reconstructive lower extremity foot and ankle surgery using a dehydrated amnion/chorion allograft membrane.

Amniotic membranes are known to be rich in growth factors, cytokines, and matrix proteins, which can help support wound closure and may improve patient outcomes in foot and ankle surgical interventions. In this Institutional Review Board (IRB) approved clinical study, 21 consecutive patients undergoing lower extremity soft tissue and bone reconstruction surgery received dehydrated human amnion and chorion allograft (dHACA) placed as a covering over the deep layers of the surgical wound during closure. Wound healing complications were assessed and American Orthopaedic Foot and Ankle Society (AOFAS) scores were compiled from over a 1-year follow-up period. Summary statistics were calculated for average pain, function, and alignment. The average overall AOFAS pre-treatment score was 35.8 ± 23.0 and the post-treatment score significantly improved to 87.5 ± 6.4 (P = 3.7 × 10-10 ). The pain-score improved from pre-treatment at 10.0 ± 11.0 to post-treatment at 36.7 ± 4.8 (P = 5.0 × 10-5 ). The pre-treatment function score was 18.7 ± 12.9 and at post-treatment increased to 38.5 ± 5.7 (P = 5.8 × 10-5 ). Lastly, the alignment score at pre-treatment was 7.1 ± 4.4 and at post-treatment was 12.4 ± 2.6 (P = .001). These improvements in functional scores were accompanied with clinical observations of reduced surgical complications including a lack of wound dehisance in the cohort. These clinical findings suggest that the application of aseptically processed dHACA may reduce wound complications and as such may aide in clinical improvements in foot and ankle surgical interventions however a larger comparative trial should be considered to validate these initial findings.

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

BACKGROUND: Diabetic 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. METHODS: Pubmed, 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. RESULTS: When 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. CONCLUSION: Even 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.

Comparative Study on the Efficacy of Frozen Amniotic Membrane Transplantation and Lamellar Keratoplasty in the Treatment of Mooren Ulcer.

OBJECTIVE: To compare of the clinical efficacy of frozen amniotic membrane transplantation (AMT) and lamellar keratoplasty (LKP) in the treatment of Mooren ulcer. METHOD: Forty patients (42 eyes) with Mooren's ulcer in our hospital from January 2010 to January 2019 were divided into frozen AMT group (20 eyes) and LKP group (22 eyes). Comparative observation of post-operative best corrected visual acuity (BCVA), corneal epithelial healing time, corneal epithelialization time, ulcer healing, corneal transparency, corneal graft transparency, neovascularization and original disease recurrence were observed. RESULTS: The average BCVA at post-operative 6 and 12 months in LKP group were significantly lower than AMT group (P < 0.05). The ulcer healing rates in LKP group (63.6) were significantly higher than AMT group (30) (P < 0.05). The corneal epithelialization time of LKP group were 9.55 ±â€Š1.26 days. The corneal epithelial healing time of AMT group were 13.50 ±â€Š2.21 days. Nine cases were corneal graft transparency grade 0, and 13 cases were grade I. Three eyes in AMT group were corneal transparency grade 0, 7 were grade I and 10 were grade II. Corneal neovascularization were observed in 3 eyes in AMT group and 4 eyes in LKP group. The original disease recurrence rates in LKP group (50) were significantly higher than AMT group (20) (P < 0.05). Four cases of primary corneal transplantation failure were observed in LKP group. CONCLUSION: Lamellar keratoplasty group obtained significantly better BCVA during follow-up and faster healing time than the frozen AMT group while frozen AMT group had lower original disease recurrence rates than LKP group.

Human Amnion Chorion Membrane Allografts in the Treatment of Chronic Diabetic Foot Ulcers: A Literature Review.

OBJECTIVE: To discuss human amnion chorion (placental) membrane allograft (HACMA) use for the treatment of chronic diabetic foot ulcers (DFUs) and to evaluate the effectiveness, cost, and product waste of this therapy. DATA SOURCES: PubMed, Cochrane, and OVID databases. STUDY SELECTION: Twenty-four articles pertaining to HACMA and DFUs published from 2016 to 2020 were selected. DATA EXTRACTION: The data collected included type of wound care product, study design, study size, baseline size of DFU, cost, product wastage, number of applications, and wound healing outcomes. DATA SYNTHESIS: Human amnion chorion membrane allografts in the treatment of chronic DFUs have led to a reduction in healing time and increased the overall percentage of healing, making them more effective in treating DFUs compared with standard of care. These products are offered in multiple sizes with various shelf lives and methods of storage, making them accessible, easy to use, less wasteful, and lower in cost compared with other commercially available products. Promising evidence demonstrates that HACMAs are beneficial in treating complex, high-grade DFUs with exposed tendon or bone. CONCLUSIONS: Human amnion chorion membrane allografts are effective in treating chronic DFUs with a greater percentage of complete wound closure and a reduction in healing time versus standard of care.

An evaluation of dehydrated human amnion/chorion membrane allografts for pressure ulcer treatment: a case series.

OBJECTIVE: Pressure ulcers (PU; also known as pressure injuries) affect about three million adults in the US and cost an estimated $11 billion dollars annually to treat. Prevention is most desirable, however, once a patient develops a PU, the focus shifts to effective treatment and rapid closure to improve health outcomes. We sought to evaluate outcomes in 10 patients with category II and III PUs treated with dehydrated human amnion/chorion membrane (dHACM) allografts. METHOD: All patients were treated with weekly application of dHACM plus standard wound care (SoC) and followed for eight weeks. RESULTS: Of the PUs, two were category II and eight were category III. The average PU size at dHACM initiation was 3.42±1.76cm2. After the first application of dHACM 7/10 (70%) of PUs responded to treatment with a reduction in wound size. Within two weeks of dHACM initiation into the plan of care, 4/10 (40%) of PUs had reduced in size by >50%. By week four, 60% of PUs (6/10) had reduced in size by >50%. Overall, during the eight week evaluation period, 9/10 PUs reduced in size, three of which healed completely. CONCLUSION: dHACM allografts appear to be a viable treatment option for category II and III PUs.

Barriers to Epineural Scarring: Role in Treatment of Traumatic Nerve Injury and Chronic Compressive Neuropathy.

The physiological limitations of neural regeneration make peripheral nerve surgery challenging to both the surgeon and the patient. Presence of nerve gaps and local wound factors may all influence outcome, suggesting that barriers to reduce perineural scarring, minimize fibrosis, and avoid ischemia would be beneficial. To examine the evidence supporting their use, we reviewed the autologous and commercially-available options for barriers against scarring around a nerve. Numerous clinical case series demonstrated the effectiveness and safety of local/rotational flaps and autologous vein wrapping when used in the presence of recurrent compressive neuropathy. Translational research in animal models supports the biocompatibility of commercially available nerve wraps following nerve repair. To date, there are no reports of clinical use of commercially available nerve wraps in acute nerve repair, but a growing number of case series demonstrate their effectiveness and safety in chronic compressive neuropathy. Limited clinical evidence exists to support the efficacy of vein or flap coverage in acute nerve repairs.

A multicentre randomised controlled trial evaluating the efficacy of dehydrated human amnion/chorion membrane (EpiFix® ) allograft for the treatment of venous leg ulcers.

A randomised, controlled, multicentre clinical trial was conducted to evaluate the efficacy of dehydrated human amnion/chorion membrane (EpiFix) allograft as an adjunct to multilayer compression therapy for the treatment of non-healing full-thickness venous leg ulcers. We randomly assigned 109 subjects to receive EpiFix and multilayer compression (n = 52) or dressings and multilayer compression therapy alone (n = 57). Patients were recruited from 15 centres around the USA and were followed up for 16 weeks. The primary end point of the study was defined as time to complete ulcer healing. Participants receiving weekly application of EpiFix and compression were significantly more likely to experience complete wound healing than those receiving standard wound care and compression (60% versus 35% at 12 weeks, P = 0·0128, and 71% versus 44% at 16 weeks, P = 0·0065). A Kaplan-Meier analysis was performed to compare the time-to-healing performance with or without EpiFix, showing a significantly improved time to healing using the allograft (log-rank P = 0·0110). Cox regression analysis showed that subjects treated with EpiFix had a significantly higher probability of complete healing within 12 weeks (HR: 2·26, 95% confidence interval 1·25-4·10, P = 0·01) versus without EpiFix. These results confirm the advantage of EpiFix allograft as an adjunct to multilayer compression therapy for the treatment of non-healing, full-thickness venous leg ulcers.

Inhibition of recurrence of epithelial ingrowth with an amniotic membrane pressure patch to a laser in situ keratomileusis flap with a central stellate laceration: a case report.

BACKGROUND: Surgical lifting and scraping is a well-known treatment for epithelial ingrowth, but treatment for epithelial ingrowth on the centrally perforated laser in situ keratomileusis (LASIK) flap has not been well studied. CASE PRESENTATION: We present a patient who had epithelial ingrowth to the backside of the flap through a central LASIK flap laceration with a stellate shape. The patient had undergone uncomplicated bilateral LASIK surgery 3 years before the trauma. Because the epithelial ingrowth was suspected during the first visit 2 weeks after trauma, and definite epithelial ingrowth was noted during the additional 2 week observation period, the ingrown epithelial tissue was removed mechanically with a number 15 blade after lifting of the flap 4 weeks after the trauma. An amniotic membrane overlay was applied over the cornea and was sutured tightly to the episclera to firmly press down the flap to the remaining posterior stroma, to prevent growth of the epithelium again to the backside of the flap. At the last follow-up visit, 5 months after surgery, the patient's visual acuity remained stabilized with no sign of recurrent epithelial ingrowth. CONCLUSION: These results showed that an amniotic membrane patch can be a useful adjuvant in the treatment of epithelial ingrowth, even on the central stellate laceration of the LASIK flap over the visual axis.

Dehydrated human amnion/chorion tissue in difficult-to-heal DFUs: a case series.

UNLABELLED: Diabetic foot ulcers (DFUs) occur as a result of multifactorial complications and are commonly found in the diabetic community. Underlying disease states such as neuropathy and peripheral vascular disease can slow healing rates, potentially leading to recurrence, amputation, and increased mortality. As with many other disease processes, DFUs have several treatment options, such as debriding agents, alginate seaweed extract, hydrocolloid gels, and amniotic membrane allografts. The presented cases all used a dehydrated human amniotic/chorionic membrane allograft (dHACM; EpiFix) to aid the healing process. Human amniotic epithelial membranes have seen increased usage due to their ability to enhance the healing process and accelerate cellular regeneration. The DFUs healed in all of the five patients treated, and patients saw a full recovery in 2.5-11 weeks. In addition, the healing time decreased in spite of the non-adherence seen in three of the patients. These results suggest another possible use for dHACM; however, further studies are required to confirm these data. DECLARATION OF INTEREST: This project was self-funded and had no influences outside the fact that Dr Penny is a speaker for MiMedx.

Dehydrated human amnion/chorion membrane for the treatment of severe skin and tissue loss in an preterm infant: a case report.

Extreme prematurity complicated with severe congenital cutaneous candidiasis (CCC) is rare and clinically challenging. We present the case of a 615g dizygotic twin delivered at 24 weeks gestation with congenital candidiasis, who developed severe skin and tissue loss, successfully treated with dehydrated human amnion/chorion membrane (dHACM). The infant had a complicated medical course, including treatment for patent ductus arteriosus (PDA), necrotising enterocolitis (NEC), and neonatal abstinence syndrome (NAS). In the operating room after debridement, dHACM was placed over all abdominal and back areas of skin loss and covered with a non-occlusive, non-adherent silver dressing. This dressing regimen was chosen in an effort to provide not only topical antimicrobial coverage, but also to maintain a non-shear, moist wound healing environment, which was so important in the dry incubator environment of the neonatal intensive care centre. Over the next four weeks, the baby was medically managed, and the wounds healed on their own with only weekly bedside dressing changes. This case report provides the first example of successful complex management of extensive life-threatening wounds in a premature infant using dHACM.

Spontaneous bilateral corneal perforation in a patient with ichthyosis.

We present an 8-month-old female patient with bilateral spontaneous corneal perforation and lamellar ichthyosis. On examination, the skin of the body and face of the patient was completely dry and scaly. Cicatricial ectropion and descemetocele with small perforations were seen. Double-layered amniotic membrane transplantation on the cornea with eyelid construction was performed on both eyes. At the 6-month follow-up, lower eyelid minimal ectropion formation and inferior corneal leukoma were seen bilaterally. In ichthyosis patients, the cornea should be monitored closely due to the risk of severe visual loss and corneal perforation.

Placement of ProKera in the management of ocular manifestations of acute Stevens-Johnson syndrome in an outpatient.

PURPOSE: To report the clinical use of ProKera (Bio-Tissue, Inc., Miami, FL) under topical anesthesia in an outpatient for the management of ocular manifestations of acute Stevens-Johnson syndrome (SJS). METHODS: Interventional case report. RESULTS: A 19-year-old woman developed acute SJS with ocular involvement after ingestion of oral antibiotics. Slit-lamp examination performed 2 weeks later showed severe inflammation and areas of ulceration along all 4 lids and complete, bilateral sloughing of bulbar and palpebral conjunctivae, including the limbus. ProKera was placed under topical anesthesia without sedation in both eyes instead of an amniotic membrane due to excess risk of general anesthesia. Three weeks after placement, slit-lamp examination showed complete re-epithelialization of both corneas and conjunctivae, with only trace conjunctival injection and minor limbal epithelial irregularities. Three months postprocedure, there were no signs of clinically significant scarring, and the visual acuity (VA) was 20/20 bilaterally. Fourteen months postprocedure, VA remained stable, and the patient did not have dry eye, photophobia, clinically significant scarring, or symblepharon. CONCLUSIONS: ProKera placement performed under topical anesthesia may be appropriate for the treatment of ocular surface manifestations of acute SJS particularly in those patients followed in an outpatient setting with milder forms of disease and/or with contraindications to general anesthesia.

Comparison of conjunctival autograft transplantation and amniotic membrane transplantation for pterygium: a meta-analysis.

BACKGROUND: Conjunctival autograft transplantation (CAT) and amniotic membrane transplantation (AMT) are two widely used techniques for pterygium treatment. However, previous studies comparing the outcomes of CAT and AMT have generally had small sample sizes and conflicting results. The aim of this report was to evaluate and comment on peer-reviewed literature for evidence of effectiveness and safety of CAT and AMT for management of pterygium. METHODS: Studies comparing outcomes of CAT and AMT for pterygium treatment were identified by searching PubMed, Embase, Web of Knowledge, and a search of all references in relevant papers. Two reviewers confirmed study eligibility and extracted data independently, and data were pooled using standard meta-analysis techniques. RESULTS: Five eligible studies reporting outcomes in 538 eyes were included. The pooled hazard ratio (HR) estimate for recurrence of CAT compared to AMT was 0.30 (95% confidence interval (CI) [0.16, 0.59], p < 0.001) and 0.22 (95%CI [0.02, 2.37], p = 0.214), respectively, for primary and recurrent pterygium. For unacceptable appearance, the pooled HR estimate was 0.33 (95% CI [0.16, 0.66], p = 0.002). There were no statistically significant differences in adverse events (odds ratio (OR) = 0.96, 95% CI [0.46, 1.97], p = 0.901). CONCLUSIONS: Available trials indicate that CAT has lower recurrence risk compared to AMT for primary pterygium treatment, as well as lower risk of unacceptable appearance risk.

Complex limbal choristoma in nevus sebaceous syndrome.

Excision of an epibulbar choristoma followed by amniotic membrane grafting was performed on a 3-month-old baby who presented with nevus sebaceous syndrome. Upon histopathologic examination, the excised mass was seen to be a complex choristoma, a rare ocular tumor. Amniotic membrane transplantation is currently the most acceptable modality of treatment of limbal choristoma, with good cosmetic outcome.

Placental-based allograft use for tissue regeneration and scar prevention for neurosurgical wounds.

Tweetable abstract Proper wound healing, including internal and surface tissue regeneration with the minimization of scar formation, is one of the most significant topics in surgical discussions and EpiFix® dehydrated human amnion/chorion membrane allograft promotes healthy healing.

Human amniotic membrane products for patients with diabetic foot ulcers. do they help? a systematic review and meta-analysis.

BACKGROUND: Diabetic foot ulcer (DFU) is one of the most serious diabetic complications. DFU is an open wound that usually occurs in the foot sole due to poor blood glucose control, peripheral neuropathy, and poor circulation. The human amniotic allograft membrane is a biological wound dressing derived from the amniotic membrane. It contains amino acids, nutrients, cytokines, and growth factors that make the growth process easier. OBJECTIVE: To compare dehydrated human amnion and chorion allograft (DHACA) plus the standard of wound care (SOC) with the SOC alone. METHODS: We searched for randomized clinical trials (RCTs) on PubMed, Scopus, Cochrane, and Web of Science till April 2021 using relevant keywords. All search results were screened for eligibility. We extracted the data from the included trials and pooled them as mean difference (MD) or risk ratio (RR) with the 95% confidence interval (CI) using Review Manager software (ver. 5.4). RESULTS: The pooled effect estimate from 11 RCTs showed that DHACA was superior to SOC regarding the complete wound healing in both 6th and 12th week (RR = 3.78; 95% CI: [2.51, 5.70]; P < 0.00001) and (RR = 2.00; 95% CI: [1.67, 2.39], P < 0.00001 respectively). Also, the analysis favored the DHACA regarding the mean time to heal in the 12th-week (MD = -12.07, 95%CI: [-19.23, -4.91], P = 0.001). The wound size reduction was better with DHACA (MD = 1.18, 95%CI: [-0,10, 2.26], P = 0.03). CONCLUSION: Using DHACA with SOC is safer and more effective than using SOC alone for DFU patients.