Amniotic miracle: Investigating the unique development and applications of amniotic membrane in wound healing.

BACKGROUND: The perfect repair of damaged skin has always been a constant goal for scientists; however, the repair and reconstruction of skin is still a major problem and challenge in injury and burns medicine. Human amniotic membrane (hAM), with its good mechanical properties and anti-inflammatory, antioxidant and antimicrobial benefits, containing growth factors that promote wound healing, has evolved over the last few decades from simple skin sheets to high-tech dressings, such as being made into nanocomposites, hydrogels, powders, and electrostatically spun scaffolds. This paper aims to explore the historical development, applications, trends, and research hotspots of hAM in wound healing. METHODS: We examined 2660 publications indexed in the Web of Science Core Collection (WoSCC) from January 1, 1975 to July 12, 2023. Utilizing bibliometric methods, we employed VOSviewer, CiteSpace, and R-bibliometrix to characterize general information, identify development trends, and highlight research hotspots. Subsequently, we identified a collection of high-quality English articles focusing on the roles of human amniotic epithelial stem cells (hAESCs), human amniotic mesenchymal stem cells (hAMSCs), and amniotic membrane (AM) scaffolds in regenerative medicine and tissue engineering. RESULTS: Bibliometric analysis identified Udice-French Research Universities as the most productive affiliation and Tseng S.C.G. as the most prolific author. Keyword analysis, historical direct quotations network, and thematic analysis helped us review the historical and major themes in this field. Our examination included the knowledge structure, global status, trends, and research hotspots regarding the application of hAM in wound healing. Our findings indicate that contemporary research emphasizes the preparation and application of products derived from hAM. Notably, both hAM and the cells isolated from it - hADSCs and hAESCs are prominent and promising areas of research in regenerative medicine and tissue engineering. CONCLUSION: This research delivers a comprehensive understanding of the knowledge frameworks, global dynamics, emerging patterns, and primary research foci in the realm of hAM applications for wound healing. The field is rapidly evolving, and our findings offer valuable insights for researchers. Future research outcomes are anticipated to be applied in clinical practice, enhancing methods for disease prevention, diagnosis, and treatment.

Amniotic membrane dressings for treatment of aplasia cutis in newborns.

BACKGROUND: Aplasia cutis congenita (ACC) is a rare congenital skin defect characterized by a focal or extensive absence of the epidermis, dermis, and occasionally, subcutaneous tissue. When the wound caused by this defect is wide or deep, various treatments are used, including skin grafting. The amniotic membrane (AM) is a biological dressing that facilitates re-epithelialization as it contains mesenchymal cells and numerous growth factors. OBJECTIVE: To report the efficacy of AM dressings in treating the skin defects of ACC. METHOD: This study was conducted on five neonates diagnosed with ACC born between 2018 and 2022, referred to the Children's Medical Center in Tehran, Iran. AM dressings were applied on wounds larger than 1 cm2. The wounds were assessed weekly and, if required, an additional AM dressing was applied. RESULTS: The skin defects gradually re-epithelialized after application of the AM. The complete healing process took around 3.5 weeks on average. No hypertrophic scarring was observed. CONCLUSION: The application of AM dressing resulted in satisfactory cosmetic outcomes, with no hypertrophic scar formation. Complete healing occurred in all cases except one. The length of the hospital stay ranged from 2 to 6 weeks, depending on the size of the wound.

Dehydrated Amnion Chorion Membrane versus standard of care for diabetic foot ulcers: a randomised controlled trial.

OBJECTIVE: Diabetic foot ulcers (DFUs) continue to challenge wound care practitioners. This prospective, multicentre, randomised controlled trial (RCT) evaluated the effectiveness of a dehydrated Amnion Chorion Membrane (dACM) (Organogenesis Inc., US) versus standard of care (SoC) alone in complex DFUs in a challenging patient population. METHOD: Subjects with a DFU extending into dermis, subcutaneous tissue, tendon, capsule, bone or joint were enrolled in a 12-week trial. They were allocated equally to two treatment groups: dACM (plus SoC); or SoC alone. The primary endpoint was frequency of wound closure determined by a Cox analysis that adjusted for duration and wound area. Kaplan-Meier analysis was used to determine median time to complete wound closure (CWC). RESULTS: The cohort comprised 218 patients, and these were split equally between the two treatment groups with 109 patients in each. A Cox analysis showed that the estimated frequency of wound closure for the dACM plus SoC group was statistically superior to the SoC alone group at week 4 (12% versus 8%), week 6 (22% versus 11%), week 8 (31% versus 21%), week 10 (42% versus 27%) and week 12 (50% versus 35%), respectively (p=0.04). The computed hazard ratio (1.48 (confidence interval: 0.95, 2.29) showed a 48% greater probability of wound closure in favour of the dACM group. Median time to wound closure for dACM-treated ulcers was 84 days compared to 'not achieved' in the SoC-treated group (i.e., ≥50% of SoC-treated DFUs failed to heal by week 12; p=0.04). CONCLUSION: In an adequately powered DFU RCT, dACM increased the frequency, decreased the median time, and improved the probability of CWC when compared with SoC alone. dACM demonstrated beneficial effects in DFUs in a complex patient population. DECLARATION OF INTEREST: This study was funded by Organogenesis Inc., US. JC serves as a consultant and speaker for Organogenesis. RDD serves as a speaker for Organogenesis. OMA and MLS serve as consultants for Organogenesis. The authors have no other conflicts of interest to declare.

Management of post-Mohs surgical wounds with a hypothermically stored amniotic membrane: a case series.

OBJECTIVE: The aim of this case series is to present an alternative approach to managing post-Mohs Micrographic Surgery (Mohs) wounds with hypothermically stored amniotic membrane (HSAM). METHOD: A case series of patients with post-Mohs wounds is presented, with four patients referred for hard-to-heal wounds following a Mohs procedure that was performed 1-3 months previously. All wounds underwent weekly assessment, debridement, and application of HSAM and secondary dressings. Treatment also included management of bioburden, proper skin care and compression therapy for lower extremity wounds. RESULTS: This case series of seven wounds consisted of four females and three males with a mean age of 87.6 years. Mean wound size at first application of HSAM was 1.34±1.20cm2. All wounds closed, with an average time to wound closure of 43.7±27.1 days. Patients received an average of 4.6±2.5 HSAM applications. The four post-Mohs wounds with a history of being hard-to-heal had an average time to wound closure of 35.5±16.3 days, with an average duration of 86.5±32.4 days prior to the first HSAM application. CONCLUSION: The results of this case series suggest that use of HSAM may provide an alternative approach to managing post-Mohs wounds. In addition, these findings suggest that HSAM may be of greatest benefit when applied early after Mohs surgery.

Hyperdry Human Amniotic Membrane as a Protective Dressing for Open Wounds With Exposed Bowel in Mice.

INTRODUCTION: An enteroatmospheric fistula forms when the exposed bowel is perforated with chronic enteric fistula formation. Currently, there is no established preventative method for this condition. Hyperdry (HD) amniotic membrane (AM) can promote early granulation tissue formation on the exposed viscera and is suitable for dressing intractable wounds as it possesses anti-inflammatory, antibacterial, and immunomodulatory properties. This study investigated whether HD-AM promotes early formation of blood vessel-containing granulation tissue for enteroatmospheric fistula treatment. METHODS: An experimental animal model of an open wound with exposed bowel was developed. A 15 × 20 mm wound was prepared on the abdomen of Institute of Cancer Research mice, and the HD-AM was placed. The mice were assigned to one of the following groups: HD-AM group, in which the stromal layer of the HD-AM was placed in contact with the exposed bowel; HD-AM UD group, in which the epithelial layer of the HD-AM was placed in contact with the exposed bowel; and the HD-AM (-) or control group, in which the HD-AM was not used. RESULTS: On postoperative days 7 and 14, granulation tissue thickness significantly increased in the HD-AM and HD-AM UD groups compared with that in the HD-AM (-) group. Macrophages accumulated in the HD-AM epithelium only in the HD-AM group. During HD-AM contact, a subset of invading macrophages switched from M1 to M2 phenotype. CONCLUSIONS: HD-AM is a practical wound dressing with its scaffolding function, regulation of TGF ß-1 and C-X-C motif chemokine 5 (CXCL-5), and ability to induce M1-to-M2 macrophage conversion.

A pilot study of the use of human amniotic membrane as subcutaneous implants in a mouse model: a potential for temporary substitutes in two-stage breast reconstructions.

INTRODUCTION: Breast reconstruction by prosthesis is frequently performed in breast cancer treatments, and a temporary substitute is used in the first step of two-stage operations. AIM: Due to the advantageous biological features of the human amniotic membrane, we aimed to evaluate its use for temporary implants. METHOD: We prepared small spherical implants from human amniotic membranes and inserted them into BALB/c mice's subcutaneous flanks. Then, we compared the bulging they produced, the durability, and the host reaction with implants made from the chorionic membrane, folded membrane patches, and sterile plastic beads. RESULTS: All amionitic cases were healthy throughout the study and only mild inflammation occurred in them. Furthermore, the bulging of the implants was acceptable and faded gradually. However, moderate inflammation was observed in chorionic implant mice, and the bulging disappeared very soon. Finally, the control group had severe inflammation and the beads implant was rejected. CONCLUSION: Our study showed that the human amniotic membrane could represent a safe and valid tool for breast reconstruction, however, further studies on larger animals and more implants are suggested.

[Collagen-based biological dressings in the treatment of chronic wounds in diabetic foot syndrome]. / Biologicheskie povyazki na osnove kollagena v lechenii khronicheskikh ran pri sindrome diabeticheskoi stopy.

One of the end-organs of diabetes mellitus (DM) is the skin. Cellular and molecular disorders occurring in the skin due to chronic hyperglycemia, neuropathy, and micro- and macroangiopathy lead to poor-heling foot wounds in patients with diabetes. Consequently, treating wounds in diabetic foot syndrome (DFS) is prolonged, costly, and often ineffective. The research on wound healing and treating wounds in DM with stricter adherence to international guidelines and technological breakthroughs in developing biological materials provide new therapeutic opportunities to solve wound care problems. Collagen is one of the body's many proteins, essential throughout the healing phases for skin repair and remodeling. Collagen is one of the body's many proteins, essential throughout the healing phases for skin repair and remodeling. The article addresses the features of biological dressings based on the lyophilized native triple-helix (non-hydrolyzed) collagen formulation. Also, we present clinical cases of their use in different phases of wound healing in DM.

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.

A real-world experience with the bioactive human split thickness skin allograft for venous leg ulcers.

Data collected from standardized clinical practices can be valuable in evaluating the real-world therapeutic benefit of skin substitutes in the treatment of venous leg ulcers (VLU). Utilizing such a dataset, this study aimed to validate the effectiveness of a bioactive human split-thickness skin allograft for the treatment of VLU in the real-world setting and to understand how certain variables impacted healing rates. From a pool of 1474 VLU treated with allograft, 862 ulcers in 742 patients were selected from a large wound EMR database and analyzed. All patients received standard wound care prior to allograft application. Impact of ulcer duration, number of applications, ulcer size, and time to application were analyzed. The VLU, on average, were of 189 days duration with a mean ulcer size of 19.3 cm2 . During treatment, 70.7% of wounds healed, with an average time to closure of 15 weeks (SD = 14.1 weeks). The percentage of VLU less than one-year duration that healed was significantly higher (72.3%) than the percentage of VLU with duration of greater than 1 years (51.5%) ( χ2 = 18.17; P < .001). Ulcers less than 10 cm2 in size were more likely to heal (73.9%) than those larger than 10 cm2 (67.9%) ( χ2 = 8.65, P = .03). VLU receiving allograft within 90 days of initial presentation are 1.4 times more likely to heal vs those receiving their first BSA application after 90 days of standard of care (95% CI: [1.05, 1.86], P = .02). Allograft used in wound clinics healed a majority of refractory VLU, even in large ulcers of long duration, which are more difficult to heal. Smaller wound, size, and shorter wound duration were associated with greater likelihood of healing. VLUs treated earlier with allograft had better healing outcomes. Clinicians may consider more aggressive and timely treatment with allograft for refractory VLU.

Effectiveness and safety of human amnion/chorion membrane therapy for diabetic foot ulcers: An updated meta-analysis of randomized clinical trials.

Human amnion/chorion membrane therapy has shown advantages in the management of diabetic foot ulcers and its effectiveness has been evaluated in the systematic reviews and meta-analyses. However, the number of patients included in the previous literatures was small and the safety profile of human amnion/chorion membrane therapy was not concerned. Therefore, we conducted an updated meta-analysis to better understand the effectiveness and safety of human amnion/chorion membrane therapy for diabetic foot ulcers. The PubMed, Embase, Cochrane Library, and ClinicalTrial.gov databases were searched for any randomized clinical trials comparing human amnion/chorion membrane therapy and standard therapy in the treatment of diabetic foot ulcers. Ulcer healing rate was considered as the primary outcome and the secondary outcomes mainly included mean time to ulcer healing and adverse events. Nine RCTs with 541 patients were included. Compared with merely standard therapy, human amnion/chorion membrane therapy plus standard therapy improved the ulcer healing rates at 6 weeks (RR = 3.50, 95% CI: 2.35-5.21), 12 weeks (RR = 2.09, 95% CI: 1.53-2.85) and 16 weeks (RR = 1.70, 95% CI: 1.25-2.30), and also shortened the healing time (MD = -4.58, 95% CI: -5.70 to -3.46). Meanwhile, no significant difference was observed in the number of patients with adverse events (RR = 0.56, 95% CI: 0.31-1.03) between two groups. This meta-analysis suggests that human amnion/chorion membrane therapy as an adjuvant treatment could promote the healing of diabetic foot ulcers and has a safety profile. More evidence from large high-quality randomized clinical trials with long follow-up duration are in urgent need to further confirm our findings.

Fish skin grafts compared to human amnion/chorion membrane allografts: A double-blind, prospective, randomized clinical trial of acute wound healing.

Chronic, nonhealing wounds consume a great deal of healthcare resources and are a major public health problem, associated with high morbidity and significant economic costs. Skin grafts are commonly used to facilitate wound closure. The grafts can come from the patient's own skin (autograft), a human donor (allograft), or from a different species (xenograft). A fish skin xenograft from cold-water fish (Atlantic cod, Gadus morhua) is a relatively recent option that shows promising preclinical and clinical results in wound healing. Chronic wounds vary greatly in etiology and nature, requiring large cohorts for effective comparison between therapeutic alternatives. In this study, we attempted to imitate the status of a freshly debrided chronic wound by creating acute full-thickness wounds, 4 mm in diameter, on healthy volunteers to compare two materials frequently used to treat chronic wounds: fish skin and dHACM. The purpose is to give an indication of the efficacy of the two therapeutic alternatives in the treatment of chronic wounds in a simple, standardized, randomized, controlled, double-blind study. All volunteers were given two identical punch biopsy wounds, one of which was treated with a fish skin graft and the other with dehydrated human amnion/chorion membrane allograft (dHACM). In the study, 170 wounds were treated (85 wounds per group). The primary endpoint was defined as time to heal (full epithelialization) by blinded assessment at days 14, 18, 21, 25, and 28. The superiority hypothesis was that the fish skin grafts would heal the wounds faster than the dHACM. To evaluate the superiority hypothesis, a mixed Cox proportional hazard model was used. Wounds treated with fish skin healed significantly faster (hazard ratio 2.37; 95% confidence interval: (1.75-3.22; p = 0.0014) compared with wounds treated with dHACM. The results show that acute biopsy wounds treated with fish skin grafts heal faster than wounds treated with dHACM.

Evaluation of fish skin as a biological dressing for metacarpal wounds in donkeys.

BACKGROUND: The use of biological dressings has recently emerged in the management of burns and wounds. The aim of the present study was to evaluate the Nile tilapia skin as a biological dressing for full-thickness cutaneous metacarpal wounds in donkeys. The study was conducted on nine clinically healthy donkeys (n = 9). Here, fish skin dressings were obtained from fresh Nile tilapia (Oreochromis niloticus and sterilized by immersion in silver nanoparticles (AgNPs) solution for 5 min, with no change in collagen content. Bilateral, circular full-thickness excisional skin wounds (2 cm in diameter) were created on the dorsal aspect of the mid-metacarpals of each donkey. Wounds on the right metacarpals (treated wounds, n = 9) were dressed with sterile fish skins, while wounds on the left metacarpals (control wounds, n = 9) were dressed with sterile non-adherent dressing pads without any topical applications. Wound dressings were changed weekly. Wounds were evaluated microbiologically, grossly, and histologically on days 7, 14, and 21 post-wound inductions. RESULTS: Fish skin-dressed wounds showed a significant (P < 0.0001) reduction in microbial counts (Total viable bacterial count, Staphylococcal count, and Coliform count), a significant (P < 0.0001) decrease in the wound size, and a significant reduction (P < 0.0001) in the epithelial gap compared to the untreated wounds. No frequent dressing changes were needed. CONCLUSIONS: Fish skin dressing accelerated the wound healing process and efficiently inhibited the local microbial activity and exuberant granulation tissue formation suggesting its reliable and promising application for metacarpal wounds of donkeys.

Ablative Fractional Resurfacing for Chronic Wounds from Traumatic Scarring: A Case Report and Literature Review.

Ablative fractional resurfacing (AFR) can be utilized to improve scar appearance, texture, pain and associated contractures. Non-healing ulcers can also develop in areas of scarring and, in some cases, AFR can be utilized to heal these chronic wounds. We present a case of scarring with non-healing ulceration refractory to wound care, debridement and hydrotherapy successfully healed in four sessions with AFR using a 2940 nm Er:YAG laser. We review the literature on AFR for wound healing including potential mechanisms. AFR can be considered for non-healing ulcers in areas of scarring, once malignancy and infection are ruled out, and has the potential to provide relief for these suffering patients.J Drugs Dermatol. 2020;19(11): doi:10.36849/JDD.2020.5444.

BIO-NAIL: a bacterial cellulose dressing as a new alternative to preserve the nail bed after avulsion.

Avulsion of the nail plate is the most accomplished surgical procedure among the nail apparatus surgeries. Since it is not possible to use the removed nail to cover the nail bed, some materials have been suggested, however, they are generally not available for use and often at a high cost. To evaluate the use of Bacterial Cellulose (BC) dressing as a biological nail (Bio-Nail) after partial or total avulsion of the nail plate. Twenty-six candidates for nail avulsion, were randomized into two groups: Control, using Vaseline with gauze (11 patients) and Experimental group, BC group, using the Bio-Nail (15 patients). The patients were followed up during the 180-day period. The distribution of the patients in the groups was homogeneous for both sociodemographic and clinical data. The occurrence of infection (1 case in the control group) was not statistically relevant. The BC group had lower pain intensity (p = 0.011) with earlier temporal resolution when compared to the control group (p = 0.003). The BC group presented earlier reepithelization (p = 0.022) and better quantitative (p = 0.021) and qualitative conditions (p = 0.011) for the exudate. Regarding satisfaction, all the patients were satisfied. Good preservation of the nail plate area was observed in the BC group at the end of the 180-day period (p = 0.024). Average time of BC dressing permanence was 16.4 ± 7.1 days. BC showed to be appropriate as a dressing after partial or total avulsion of the nail plate. BC is a Bio-Nail promising for nail bed healing.

Wound Care With a Porcine Extracellular Matrix After Surgical Treatment of Rhinophyma.

BACKGROUND: Rhinophyma surgery is commonly associated with prolonged wound healing and the need for multiple wound dressings. OBJECTIVES: To evaluate clinical outcome with a porcine extracellular matrix (ECM) after shave excision of rhinophyma compared with common wound care procedure. MATERIALS AND METHODS: Retrospective analysis of patients with common dressings (CD) compared with patients with additional ECM (OASIS) application. Clinical findings were assessed prior to treatment and at follow-up visit using the Patient and Observer Scar Assessment Scale (POSAS), Vancouver Scar Scale (VSS), and Rhinophyma Severity Index (RHISI). RESULTS: Overall, 28 patients (67.5 ±9.0 years) with a mean wound area of 33.9 (±8.5) cm² were included. After a mean follow-up period of 132 (±73) days, scales of POSAS, VSS, and RHISI showed significant (P< .0001) reductions of 47.0% (±11.1), 56.0% (±12.0), and 62.3% (±14.3), respectively. Subgroup analysis showed no significant differences of aforementioned parameters between the ECM group (n= 17) and CD group (n= 11). In contrast, the number of dressing changes were significantly (P< .006) less in the ECM group (1.4 ±0.8) compared with CD group (4.1 ±2.6). The ECM group showed a significant (P< .017) shorter time to re-epithelization (10.5 ±1.7 days) than the CD group (13.1 ±2.2 days). CONCLUSIONS: The application of porcine ECM is practicable and reduces the number of dressing changes and time to re-epithelization clearly. Crusts are scaling off spontaneously without any aggressive action needed. Our findings indicate that ECM application is a promising approach for rhinophyma wound care.

Biological versus non-biological dressings in the management of split-thickness skin-graft donor sites: a systematic review and meta-analysis.

OBJECTIVE: There are currently no definitive guidelines regarding the management of split-thickness skin-graft (STSG) donor sites. The literature reports biological and non-biological dressings as the two main groups; however, there is no conclusive evidence regarding the ideal type. A systematic review and meta-analysis of existing clinical trials was performed to compare biological and non-biological dressings in managing STSG donor sites. METHOD: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement standards was used to conduct this study. Electronic databases including MEDLINE, Embase, CINAHL and the Cochrane Central Register of Controlled Trials (CENTRAL) were searched by two authors (SR and BL). Data analysis was performed with RevMan 5.3. RESULTS: In total, 10 studies, consisting of eight randomised controlled trials and two observational assessments, were identified. Wound healing time was faster with biological dressings compared to non-biological dressings (mean difference -5.44 days; p<0.05). A higher epithelialisation rate was also noted for biological dressings. There was no difference in the infection rate between the two study groups (odds ratio [OR] 0.39; 95% confidence interval [CI] 0.15-1.04) or wound exudation (OR 0.31; 95% CI 0.01-8.28). The pain level experienced during dressing changes in both groups was reported to be similar. CONCLUSION: The rate of epithelialisation and wound healing is greater for STSG donor sites when treated with biological dressings, but they offer no difference in terms of reducing pain, limiting infection or exudation.

Use of a dual-layer amniotic membrane in the treatment of diabetic foot ulcers: an observational study.

BACKGROUND: Despite advances in the treatment, fewer than half of diabetic foot ulcers (DFUs) heal in 12 weeks and 85% of non-traumatic amputations follow the development of a DFU. The search for treatment options continues. Placental-derived products have shown promise in the treatment of DFUs. This study investigates Artacent (Tides Medical, US), a unique amniotic patch containing two layers of amnion and its potential to increase growth factor delivery. METHOD: This observational analysis included patients with DFUs with documented failure to heal by >50% after the protocol-defined run-in period (either two or four weeks) of standard of care (SOC), and who had been randomised in a larger clinical trial that had been discontinued earlier for logistical reasons. Patients were randomised to either weekly or biweekly application of the dual-layer amniotic membrane (DLAM) plus SOC and were included in per-protocol effectiveness analyses. Descriptive statistics were chosen for this analysis. Primary endpoint was complete closure at 12 weeks. RESULTS: A total of 26 patients were included in the analysis. Examination of baseline patient characteristics revealed that the ulcers were larger than in most DFU clinical trials (4.65±4.89cm2). For the primary endpoint, 17/26 (65%, 95% CI: 44-83%) of the combined treatment arms achieved complete closure. The small sample size precluded a meaningful comparison of healing between weekly and biweekly DLAM applications. CONCLUSION: The observations taken from the discontinued clinical trial suggest that the DLAM promotes healing of DFUs. The healing rates are similar to those in other placental-based tissue studies. In addition, the relatively larger size of the ulcers suggests that the DLAM may be effective in ulcers that are more resistant to standard of care. In the future, a revised clinical trial with a greater sample size is planned.

Lyophilised tilapia skin as a xenograft for superficial partial thickness burns: a novel preparation and storage technique.

Despite a considerable decrease in its incidence worldwide, burns remain the fourth most common type of trauma. The majority of burns are small, with 75% of injuries treated on an outpatient basis. Tilapia skin, as a biological material, has been suggested as an option for the management of burn wounds. After good results were obtained with the use of a glycerolised version of tilapia skin in burned children and adults, it was hypothesised that similar outcomes could be achieved with the use of a lyophilised version of tilapia skin. We report the case of a 33-year-old female patient with scalds to the upper abdomen, and both breasts, arms and forearms. Involvement of 10% of total body surface area with superficial partial thickness burns was calculated. The good adherence of tilapia skin to the wound bed, a 10-day period for complete re-epithelialisation of the wounds and the absence of side effects suggested that the lyophilised version of tilapia skin is effective for burn treatment. Compared with glycerolisation, lyophilisation is thought to permit extended storage of sterile tissue and decreased costs related to distribution and transport, but further studies are needed to confirm this.

Prospective Multicenter Evaluation of an Advanced Extracellular Matrix for Wound Management.

OBJECTIVE: To evaluate an advanced extracellular matrix made of ovine forestomach matrix (OFM) for healing a variety of wound types. METHODS: Participants were enrolled from inpatient, outpatient, and home healthcare settings. The OFM was used to treat all wounds and applied to the wound bed every 3 to 7 days until closure. RESULTS: Researchers enrolled 29 participants with 33 wounds. Average time to wound closure was 8.2 weeks, the percentage of wounds that reduced in size by 50% or more at 4 weeks was 64%, the average wound area reduction at 4 weeks was 66%, and 73% of wounds had closed at 12 weeks. No adverse effects were observed. CONCLUSIONS: This represents the first Canadian evaluation of OFM for the treatment of wounds, and the positive healing outcomes observed could support more widespread adoption of this matrix.

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.