MA Amniotic Membrane and Amniotic Fluid
M.14
Description
Human amniotic membrane (HAM) consists of the amnion and chorion layers of the placenta. It is harvested after birth, sterilized, and either cryopreserved or dehydrated for medical use. HAM contains:
- Collagen, fibronectin, hyaluronic acid
- Growth factors and cytokines
- Anti-inflammatory and antimicrobial properties
The products are formulated either as patches, which can be applied as wound covers, or as suspensions or particulates, or connective tissue extractions, which can be injected or applied topically.
Use of a HAM graft, which is fixed by sutures, is an established treatment for disorders of the corneal surface, including neurotrophic keratitis, corneal ulcers and melts, following pterygium repair, Stevens-Johnson syndrome, and persistent epithelial defects.
Dates
-
Original Effective
12-01-2025
-
Last Review
08-06-2025
-
Next Review
08-05-2026
Policy
I. The use of human amniotic membrane is considered medically necessary for the following indications:
A. Diabetic lower extremity ulcers OR
B. Neurotrophic keratitis OR
C. Corneal ulcers and melts OR
D. Pterygium repair OR
E. Stevens-Johnson syndrome of the eye OR
F. Persistent epithelial defects of the eye OR
G. Difficult to heal chronic venous partial and full-thickness ulcers of the lower extremity that have failed standard wound therapy greater than 4-weeks duration.
II. The use of human amniotic membrane is considered not medically necessary for all other indications.
III. The use of human amniotic fluid injection is not medically necessary for all indications.
Summary of Evidence
Diabetic Lower-Extremity Ulcers
For individuals who have non-healing diabetic lower-extremity ulcers who receive a formulation of HAM or placental membrane (ie, Affinity, AmnioBand Membrane, AmnioExcel, Biovance, EpiCord, EpiFix, Grafix), the evidence includes randomized controlled trials (RCTs). Relevant outcomes are symptoms, morbid events, functional outcomes, and quality of life. The RCTs evaluating amniotic and placental membrane products for the treatment of non-healing (<20% healing with ≥2 weeks of standard care) diabetic lower-extremity ulcers have compared HAM with standard care or with an established advanced wound care product. These trials used wound closure as the primary outcome measure, and some used power analysis, blinded assessment of wound healing, and intention-to-treat analysis. For the HAM products that have been sufficiently evaluated (ie, Affinity, AmnioBand Membrane, Biovance, EpiCord, EpiFix, Grafix), results have shown improved outcomes compared with standard care, and outcomes that are at least as good as an established advanced wound care product. Improved health outcomes in the RCTs are supported by multicenter registries. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.
Lower-Extremity Ulcers due to Venous Insufficiency
For individuals who have lower-extremity ulcers due to venous insufficiency who receive a formulation of HAM, the evidence includes 3 RCTs. Relevant outcomes are symptoms, morbid events, functional outcomes, and quality of life. The published evidence on HAM for the treatment of venous leg ulcers includes 2 multicenter RCTs with EpiFix and 1 multicenter RCT with Amnioband. One RCT reported a larger percent wound closure at 4 weeks, but the percentage of patients with complete wound closure at 4 weeks did not differ between EpiFix and the standard of care. A second RCT evaluated complete wound closure at 12 weeks after weekly application of EpiFix or standard dressings with compression, but interpretation is limited by methodologic concerns. The third RCT demonstrated significantly greater blinded assessor-confirmed rates of complete wound closure at 12 weeks after weekly or twice-weekly application of AmnioBand Membrane with compression bandaging compared with compression bandaging alone. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.
Ophthalmic Conditions
Sutured HAM transplant has been used for many years for the treatment of ophthalmic conditions. Many of these conditions are rare, leading to difficulty in conducting RCTs. The rarity, severity, and variability of the ophthalmic condition was taken into consideration in evaluating the evidence.
Neurotrophic Keratitis with Ocular Surface Damage and Inflammation That Does Not Respond to Conservative Therapy
For individuals who have neurotrophic keratitis with ocular surface damage and inflammation that does not respond to conservative therapy who receive HAM, the evidence includes an RCT. Relevant outcomes are symptoms, morbid events, functional outcomes, and quality of life. An RCT of 30 patients showed no benefit of sutured HAM graft compared to tarsorrhaphy or bandage contact lens. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
Corneal Ulcers and Melts That Do Not Respond to Initial Medical Therapy
For individuals who have corneal ulcers and melts, that do not respond to initial medical therapy who receive HAM, the evidence includes a systematic review of primarily case series and a non-randomized comparative study. Relevant outcomes are symptoms, morbid events, functional outcomes, and quality of life. Corneal ulcers and melts are uncommon and variable and additional RCTs are not expected. The systematic review showed healing in 97% of patients with an improvement of vision in 53% of eyes. One retrospective comparative study with 22 patients found more rapid and complete epithelialization and more patients with a clinically significant improvement in visual acuity following early treatment with self-retained amniotic membrane when compared to historical controls. Corneal ulcers and melts are uncommon and variable and RCTs are not expected. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.
Corneal Perforation When There is Active Inflammation After Corneal Transplant Requiring Adjunctive Treatment
For individuals who have corneal perforation when there is active inflammation after corneal transplant requiring adjunctive treatment who receive HAM, the evidence is limited. Relevant outcomes are symptoms, morbid events, functional outcomes, and quality of life. No comparative evidence was identified for this indication. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
Bullous Keratopathy as a Palliative Measure in Patients Who are Not Candidates for a Curative Treatment (eg, Endothelial or Penetrating Keratoplasty)
For individuals who have bullous keratopathy and who are not candidates for curative treatment (eg, endothelial or penetrating keratoplasty) who receive HAM, the evidence includes an RCT. Relevant outcomes are symptoms, morbid events, functional outcomes, and quality of life. An RCT found no advantage of sutured HAM over the simpler stromal puncture procedure for the treatment of pain from bullous keratopathy. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
Moderate or Severe Stevens-Johnson Syndrome
For individuals who have moderate or severe Stevens-Johnson syndrome who receive HAM, the evidence includes an RCT. Relevant outcomes are symptoms, morbid events, functional outcomes, and quality of life. The evidence on HAM for the treatment of Stevens-Johnson syndrome (includes 1 RCT with 25 patients [50 eyes]) found improved symptoms and function with HAM compared to medical therapy alone. Large RCTs are unlikely due to the severity and rarity of the disease. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.
Persistent Epithelial Defects and Ulceration That Do Not Respond to Conservative Therapy
For individuals who have persistent epithelial defects that do not respond to conservative therapy who receive HAM, the evidence is limited. Relevant outcomes are symptoms, morbid events, functional outcomes, and quality of life. No comparative trials were identified on persistent epithelial defects and ulceration. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
Clinical Rationale
Diabetic Lower-Extremity Ulcers
For individuals who have non-healing diabetic lower-extremity ulcers who receive a formulation of HAM or placental membrane (ie, Affinity, AmnioBand Membrane, AmnioExcel, Biovance, EpiCord, EpiFix, Grafix, NuShield), the evidence includes RCTs. The RCTs evaluating amniotic and placental membrane products for the treatment of non-healing (<20% healing with ≥2 weeks of standard care) diabetic lower-extremity ulcers have compared HAM with standard care or with an established advanced wound care product. These trials used wound closure as the primary outcome measure, and some included power analysis, blinded assessment of wound healing, and ITT analysis. For the HAM products that have been sufficiently evaluated (ie, Affinity, AmnioBand Membrane, Biovance, EpiCord, EpiFix, Grafix, NuShield), results have shown improved outcomes compared with standard care, and outcomes that are at least as good as an established advanced wound care product. Improved health outcomes in the RCTs are supported by multicenter registries. No studies were identified that compared different amniotic or placental products, and indirect comparison between products is limited by variations in the patient populations.
At least 7 RCTs have evaluated rates of healing with amniotic membrane grafts or placental membrane graft compared to SOC or an advanced wound therapy in patients with chronic diabetic foot ulcers (see Table 1). The number of patients in these studies ranged from 25 to 218. Human amniotic membrane (HAM) or placental membrane grafts improved healing compared to SOC by 22% (EpiCord vs. Alginate dressing) to 60% (EpiFix) in the intention-to-treat (ITT) analysis (see Table 2). In a 2018 trial, the cryopreserved placental membrane Grafix was found to be non-inferior to an advanced fibroblast-derived wound therapy (Dermagraft).
Table 1. Summary of Key RCT Characteristics
| Study; Trial | Countries | Sites | Dates | Participants | Active Intervention | Comparator |
|---|---|---|---|---|---|---|
| Cazzell et al (2024)1, | U.S. | 15 | 218 patients with diabetic foot ulcers | n=109, NuShield | n=109, SOC | |
| Serena et al (2020)2, | U.S. | 14 | 76 patients with chronic (>4 weeks) non-healing diabetic foot ulcers unresponsive to SOC and extending into dermis, subcutaneous tissue, muscle, or tendon | n=38, Affinity | n=38, SOC | |
| Ananian et al (2018)3, | U.S. | 7 | 2016-2017 | 75 patients with chronic (>4 weeks) non-healing diabetic foot ulcers between 1 cm2 and 15 cm2 | n=38, Grafix weekly for up to 8 weeks | n=37, Dermagraft (fibroblast-derived) weekly for up to 8 weeks |
| Tettelbach et al (2018)4, | U.S. | 11 | 2016-2018 | 155 patients with chronic (>4 weeks) non-healing diabetic foot ulcers | n=101 EpiCord plus SOC | n=54 SOC with alginate dressing |
| DiDomenico et al (2018)5, | 80 patients with non-healing (4 weeks) diabetic foot ulcers | AmnioBand Membrane plus SOC | SOC | |||
| Snyder et al (2016)6, | 29 patients with non-healing diabetic foot ulcers | AmnioExcel plus SOC | SOC | |||
| Zelen et al (2015, 2016)7, 8 | 4 | 60 patients with less than 20% wound healing in a 2 week run-in period | EpiFix | Apligraf or SOC with collagen-alginate dressing | ||
| Tettelbach et al (2019)9, | U.S. | 14 | 110 patients with non-healing (4 weeks) lower extremity ulcers | EpiFix | SOC with alginate dressing | |
| Lavery et al (2014)10, | 97 patients with chronic diabetic foot ulcers | Grafix Weekly | SOC |
RCT: randomized controlled trial; SOC: standard of care including debridement, nonadherent dressing, moisture dressing, a compression dressing, and offloading.
Table 2. Summary of Key RCT Results
| Study | Wounds Healed | Wounds Healed | Time to Complete Healing | Adverse Events and Number of Treatments |
|---|---|---|---|---|
| Cazzell et al (2024)1, | 12 Weeks (ITT) (%) | Median | No adverse events or serious adverse events were reported | |
| N | 218 | 218 | ||
| NuShield | 50% | 84 days | ||
| SOC | 35% | not achieved by 12 weeks | ||
| p-value | .04 | |||
| Serena et al (2020)2, | 12 Weeks (ITT) (%) | 16 Weeks (ITT) (%) | Median | |
| N | 76 | 76 | 76 | |
| Affinity | 55% | 58% | 11 weeks | |
| SOC | 29% | 29% | not attained by 16 weeks | |
| p-value | .02 | .01 | ||
| HR (95% CI) | 1.75 (1.16 to 2.70) | |||
| Ananian et al (2018)3, | 8 Weeks (PP) n (%) | Patients with Index Ulcer Related Adverse Events n (%) | ||
| N | 62 | 75 | ||
| Grafix | 15 (48.4%) | 1 (5.9%) | ||
| Dermagraft | 12 (38.7%) | 4 (16.7%) | ||
| Diff (95% CI) | 9.68% (−10.7 to 28.9) | |||
| Lower bound for non-inferiority | -15% | |||
| Tettlebach et al (2018)4, | 12 Weeks (PP) n (%) | 12 Weeks (ITT) n (%) | Patients with Adverse Events (% of total) | |
| N | 134 | 155 | 155 | |
| EpiCord | 81 (81%) | 71 (70%) | 42 (42%) | |
| SOC | 29 (54%) | 26 (48%) | 33 (61%) | |
| p-value | .001 | .009 | ||
| DiDomenico et al (2018)5, | 6 Weeks (ITT) n (%) | 12 weeks ITT n (%) | Mean Days (95% CI) | |
| N | 80 | 80 | 80 | |
| AmnioBand | 27 (68) | 34 (85) | 37.0 (29.5 to 44.4) | |
| SOC | 8 (20) | 13 (33) | 67.3 (59.0 to 79.6) | |
| HR (95% CI) | 4.25 (0.44 to 0.79) | |||
| p-value | <.001 | <.001 | <.001 | |
| Snyder et al (2016)6, | 6 Weeks (PP) Mean (95% CI) |
|||
| N | 21 | |||
| AmnioExcel | 45.5% (32.9% to 58.0%) | |||
| SOC | 0% | |||
| p-value | .014 | |||
| Zelen et al (2015, 2016)7,8, | 6 Weeks ITT n (%) | Wounds Healed at 12 Weeks | Weekly Treatments | |
| N | 60 | 100 | ||
| EpiFix | 19 (95%) | NR | 3.4 | |
| Apligraf | 9 (45%) | NR | 5.9 | |
| SOC | 7 (35%) | NR | ||
| HR (95% CI) | 5.66; (3.03 to 10.57) | |||
| p-value | .003 | <.001 vs. SOC | .003 | |
| Tettelbach et al (2019)9, | Wounds Healed at 12 Weeks (ITT) n(%) | |||
| N | 110 | 110 | ||
| EpiFix | 38 (81) | |||
| SOC | 28 (55) | |||
| p-value | ||||
| Lavery et al (2014)10 | Wounds Healed at 12 Weeks | Patients With Adverse Events | ||
| N | 97a | 97 | 97 | |
| Grafix | 62.0% | 42.0 | 44.0% | |
| SOC | 21.3% | 69.5 | 66.0% | |
| p-value | <.001 | .019 | .031 | |
| Difference in wounds healed between amniotic or placental membrane and SOC | Affinity 26% AmnioBand 55% AmnioExcel 33% EpiFix 60% |
Affinity 28% EpiCord 22% Grafix 41% |
CI: confidence interval; Diff : difference; HR: hazard ratio; ITT: intention-to-treat; NR: not reported; PP: per-protocol; RCT: randomized controlled trial; SOC: standard of care.
a. Power analysis indicated that 94 patients per arm would be needed. However, after a prespecified interim analysis at 50% enrollment, the blinded review committee recommended the trial is stopped due to the efficacy of the treatment.
Lower-Extremity Ulcers Due to Venous Insufficiency
Amniotic Membrane
Three RCTs, 2 using EpiFix and 1 using AmnioBand, were identified on HAM for venous leg ulcers. Serena et al (2014) reported on an industry-sponsored multicenter open-label RCT that compared EpiFix d-HAM plus compression therapy with compression therapy alone for venous leg ulcers (see Tables 6 and 7).11, The primary outcome in this trial was the proportion of patients with 40% wound closure at 4 weeks, which was achieved by about twice as many patients in the combined EpiFix group compared with the control group (see Table 8). However, a similar percentage of patients in the combined EpiFix group and the control group achieved complete wound closure during the 4-week study. There was no significant difference in healing for wounds given 1 versus 2 applications of amniotic membrane (62% vs. 63%, respectively). Strengths of this trial included adequate power and ITT analysis with last observation carried forward. Limitations included the lack of blinding for wound evaluation and use of 40% closure rather than complete closure. A 2015 retrospective study of 44 patients from this RCT (31 treated with amniotic membrane) found that wounds with at least 40% closure at 4 weeks (n=20) had a closure rate of 80% by 24 weeks; however, this analysis did not take into account additional treatments after the 4-week randomized trial period.
A second industry-sponsored, multicenter, open-label RCT (Bianchi et al [2018; 2019]) evaluated the time to complete ulcer healing following weekly treatment with EpiFix d-HAM plus compression therapy or compression wound therapy alone (see Tables 6 and 7).12,13, Patients treated with EpiFix had a higher probability of complete healing by 12 weeks, as adjudicated by blinded outcome assessors (hazard ratio, 2.26; 95% confidence interval [CI], 1.25 to 4.10; p=.01), and improved time to complete healing, as assessed by Kaplan-Meier analysis. In per-protocol analysis, healing within 12 weeks was reported for 60% of patients in the EpiFix group and 35% of patients in the control group (p<.013) (see Table 8). Intent-to-treat analysis found complete healing in 50% of patients in the EpiFix group compared to 31% of patients in the control group (p=.0473). There were several limitations of this trial (see Tables 8 and 9). In the per-protocol analysis, 19 (15%) patients were excluded from the analysis, and the proportion of patients excluded differed between groups (19% from the EpiFix group vs. 11% from the control group). There was also a difference between the groups in how treatment failures at 8 weeks were handled. Patients in the control group who did not have a 40% decrease in wound area at 8 weeks were considered study failures and treated with advanced wound therapies. The ITT analysis used last-observation-carried-forward for these patients and sensitivity analysis was not performed to determine how alternative methods of handling the missing data would affect results. Kaplan-Meier analysis suggested a modest improvement in the time to heal when measured by ITT analysis, but may be subject to the same methodological limitations.
Serena et al (2022) reported an industry-sponsored, multicenter, open-label RCT comparing once- or twice-weekly applications of HAM (AmnioBand Membrane) plus compression bandaging with compression bandaging alone in patients with chronic venous leg ulcers (Tables 6 through 9).14, This HAM is a dehydrated aseptically processed product without terminal irradiation for sterilization. It is purported to retain the structural properties of the extracellular matrix that enhances wound healing. There were no significant differences in the proportion of wounds with percentage area reduction 40 percent at 4 weeks between all three study groups. A significantly greater proportion of patients assigned to weekly or twice-weekly HAM achieved the primary endpoint of blinded assessor-confirmed complete wound healing after 12 weeks of study treatment (75%) than those assigned to compression bandaging alone (30%; p=.001). Receiving HAM was independently associated with odds of complete healing at 12 weeks after adjusting for baseline wound area (odds ratio, 8.7; 95% CI, 2.2 to 33.6). Median reduction in wound area from baseline was also significantly greater in patients assigned to HAM therapy (100%; interquartile range, 5.3%) than those assigned to compression bandaging alone (75%; interquartile range, 68.7%; p=.012). Adverse events were reported in 55%, 60%, and 75% of the once-weekly HAM, twice-weekly HAM, and standard-of-care groups, respectively. The most commonly reported adverse events were wound-related infections (36.7%) and new ulcer (31.6%). No adverse events were attributed to study treatment.
The evidence on HAM for the treatment of venous leg ulcers includes 2 multicenter RCTs with EpiFix and 1 multicenter RCT with AmnioBand Membrane. One RCT reported a larger percent wound closure at 4 weeks, but the percentage of patients with complete wound closure at 4 weeks did not differ between EpiFix and the SOC. A second RCT evaluated complete wound closure at 12 weeks after weekly application of EpiFix or standard dressings with compression. Although a significant difference in complete healing was reported, interpretation is limited by the differential loss to follow-up and exclusions between groups. Although a subsequent publication reported ITT analysis, the handling of missing data differed between the groups and sensitivity analysis was not performed. The methodological flaws in the design, execution, and reporting of both of these RCTs limit inference that can be drawn from the results. An additional RCT evaluated outcomes using AmnioBand Membrane, a dehydrated aseptically processed product without terminal irradiation for sterilization that s purported to retain the structural properties of the extracellular matrix that enhances wound healing. The application of HAM plus SOC resulted in significantly higher rates of complete wound closure at 12 weeks compared with SOC alone. This endpoint was confirmed by a blinded assessor panel in the ITT population. All 60 subjects received the allocated intervention, and none were lost to follow-up or exited because of protocol deviation. Adverse event rates were numerically greater in the biweekly HAM group but no adverse events were attributed to appeared to be similar between groups.
Neurotrophic Keratitis with Ocular Surface Damage or Inflammation That Does Not Respond to Conservative Treatment
Khokhar et al (2005) reported on an RCT of 30 patients (30 eyes) with refractory neurotrophic corneal ulcers who were randomized to HAM transplantation (n=15) or conventional treatment with tarsorrhaphy or bandage contact lens. At the 3-month follow-up, 11 (73%) of 15 patients in the HAM group showed complete epithelialization compared with 10 (67%) of 15 patients in the conventional group. This difference was not significantly significant.
Suri et al (2013) reported on 11 eyes of 11 patients with neurotrophic keratopathy that had not responded to conventional treatment.15, The mean duration of treatment prior to ProKera insertion was 51 days. Five of the 11 patients (45.5%) were considered to have had a successful outcome.
Corneal Ulcers and Melts That Do Not Respond to Initial Medical Therapy
Corneal ulcers and melts are uncommon and variable and additional RCTs are not expected. A systematic review of 1 RCT and case series showed healing in 97% of patients with an improvement of vision in 53% of eyes. One retrospective comparative study with 22 patients found more rapid and complete epithelialization and more patients with a clinically significant improvement in visual acuity following early treatment with self-retained amniotic membrane when compared to historical controls. These results support the use of non-sutured amniotic membrane for corneal ulcers and melts that do not respond to initial medical therapy.
Bullous Keratopathy in Patients Who are Not Candidates for a Curative Treatment (eg, Endothelial or Penetrating Keratoplasty)
Dos Santos Paris et al (2013) published an RCT that compared fresh HAM with stromal puncture for the management of pain in patients with bullous keratopathy.16, Forty patients with pain from bullous keratopathy who were either waiting for a corneal transplant or had no potential for sight in the affected eye were randomized to the 2 treatments. Symptoms had been present for approximately 2 years. HAM resulted in a more regular epithelial surface at up to 180 days follow-up, but there was no difference between the treatments related to the presence of bullae or the severity or duration of pain. Because of the similar effects on pain, the authors recommended initial use of the simpler stromal puncture procedure, with use of HAM only if the pain did not resolve.
Moderate or Severe Stevens-Johnson Syndrome
One RCT from India by Sharma et al (2016) assigned 25 patients (50 eyes) with acute ocular Stevens-Johnson syndrome to c-HAM plus medical therapy (antibiotics, steroids, or lubricants) or medical therapy alone.17, The c-HAM was prepared locally and applied with fibrin glue rather than sutures. Application of c-HAM in the early stages of Stevens-Johnson syndrome resulted in improved visual acuity (p=.042), better tear breakup time (p=.015), improved Schirmer test results (p<.001), and less conjunctival congestion (p=.03). In the c-HAM group at 180 days, there were no cases of corneal haze, limbal stem cell deficiency, symblepharon, ankyloblepharon, or lid-related complications. These outcomes are dramatically better than those in the medical therapy alone group, which had 11 (44%) cases with corneal haze (p=.001), 6 (24%) cases of corneal vascularization and conjunctivalization (p=.03), and 6 (24%) cases of trichiasis and metaplastic lashes.
Persistent Epithelial Defects and Ulcerations That Do Not Respond to Conservative Therapy
Bouchard and John (2004) reviewed the use of amniotic membrane transplantation in the management of severe ocular surface disease.18, They noted that c-HAM has been available since 1995, and has become an established treatment for persistent epithelial defects and ulceration refractory to conventional therapy. However, there was a lack of controlled studies due to the rarity of the diseases and the absence of standard therapy. They identified 661 reported cases in the peer-reviewed literature. Most cases reported assessed the conjunctival indications of pterygium, scars and symblepharon, and corneal indications of acute chemical injury and postinfectious keratitis.
Quick Code Search
Procedure
Diagnosis
Codes
Innovamatrix ac, per square centimeter
Corplex p or theracor p or allacor p, per milligram
Grafix core and grafixpl core, per square centimeter
Grafix prime, grafixpl prime, stravix and stravixpl, per square centimeter
Amnioexcel, amnioexcel plus or biodexcel, per square centimeter
Biodfence dryflex, per square centimeter
Amniomatrix or biodmatrix, injectable, 1 cc
Biodfence, per square centimeter
Epifix, injectable, 1 mg
Neox cord 1k, neox cord rt, or clarix cord 1k, per square centimeter
Allowrap ds or dry, per square centimeter
Amnioband or guardian, per square centimeter
Dermavest and plurivest, per square centimeter
Biovance, per square centimeter
Neoxflo or clarixflo, 1 mg
Neox 100 or clarix 100, per square centimeter
Revitalon, per square centimeter
Affinity, per square centimeter
Nushield, per square centimeter
Woundex flow, bioskin flow, 0.5 cc
Woundex, bioskin, per square centimeter
Amnioband, 1 mg
Artacent wound, per square centimeter
Cygnus, per square centimeter
Interfyl, 1 mg
Palingen or palingen xplus, per square centimeter
Palingen or promatrx, 0.36 mg per 0.25 cc
Neopatch, per square centimeter
Floweramnioflo, 0.1 cc
Floweramniopatch, per square centimeter
Revita, per square centimeter
Amnio wound, per square centimeter
Surgigraft, per square centimeter
Cellesta, per square centimeter
Cellesta flowable amnion (25 mg per cc); per 0.5 cc
Epifix, per square centimeter
Epicord, per square centimeter
Amnioarmor, per square centimeter
Artacent ac, 1 mg
Artacent ac, per square centimeter
Restorigin, per square centimeter
Restorigin, 1 cc
Novachor, per square centimeter
Genesis amniotic membrane, per square centimeter
Cygnus matrix, per square centimeter
Matrion, per square centimeter
Xwrap, per square centimeter
Membrane graft or membrane wrap, per square centimeter
Fluid flow or fluid GF, 1 cc
Novafix, per square cenitmeter
Surgraft, per square centimeter
Amnion bio or Axobiomembrane, per square centimeter
Allogen, per cc
Ascent, 0.5 mg
Cellesta cord, per square centimeter
Axolotl ambient or axolotl cryo, 0.1 mg
Artacent cord, per square centimeter
Woundfix, BioWound, Woundfix Plus, BioWound Plus, Woundfix Xplus or BioWound Xplus, per square centimeter
Surgicord, per square centimeter
Surgigraft-dual, per square centimeter
BellaCell HD or Surederm, per square centimeter
Amniowrap2, per square centimeter
Human health factor 10 amniotic patch (hhf10-p), per square centimeter
Amniobind, per square centimeter
Amniocore, per square centimeter
Cogenex amniotic membrane, per square centimeter
Cogenex flowable amnion, per 0.5 cc
Corplex p, per cc
Corplex, per square centimeter
Surfactor or nudyn, per 0.5 cc
Xcellerate, per square centimeter
Amniorepair or altiply, per square centimeter
Carepatch, per square centimeter
Cryo-cord, per square centimeter
Derm-maxx, per square centimeter
Amnio-maxx or amnio-maxx lite, per square centimeter
Corecyte, for topical use only, per 0.5 cc
Polycyte, for topical use only, per 0.5 cc
Amniocyte plus, per 0.5 cc
Amniotext, per cc
Coretext or protext, per cc
Amniotext patch, per square centimeter
Dermacyte amniotic membrane allograft, per square centimeter
Amniply, for topical use only, per square centimeter
Amnioamp-mp, per square centimeter
Vim, per square centimeter
Vendaje, per square centimeter
Zenith amniotic membrane, per square centimeter
Novafix dl, per square centimeter
Reguard, for topical use only, per square centimeter
Mlg-complete, per square centimeter
Relese, per square centimeter
Enverse, per square centimeter
Celera dual layer or celera dual membrane, per square centimeter
Signature apatch, per square centimeter
Tag, per square centimeter
Dual layer impax membrane, per square centimeter
Surgraft tl, per square centimeter
Cocoon membrane, per square centimeter
Neostim tl, per square centimeter
Neostim membrane, per square centimeter
Neostim dl, per square centimeter
Surgraft ft, per square centimeter
Surgraft xt, per square centimeter
Complete sl, per square centimeter
Complete ft, per square centimeter
Esano a, per square centimeter
Esano aaa, per square centimeter
Esano ac, per square centimeter
Esano aca, per square centimeter
Orion, per square centimeter
Epieffect, per square centimeter
Vendaje ac, per square centimeter
Xcell amnio matrix, per square centimeter
Barrera sl or barrera dl, per square centimeter
Cygnus dual, per square centimeter
Biovance tri-layer or biovance 3l, per square centimeter
Dermabind sl, per square centimeter
Nudyn dl or nudyn dl mesh, per square centimeter
Nudyn sl or nudyn slw, per square centimeter
Dermabind dl, per square centimeter
Dermabind ch, per square centimeter
Revoshield + amniotic barrier, per square centimeter
Membrane wrap-hydro, per square centimeter
Lamellas xt, per square centimeter
Lamellas, per square centimeter
Acesso dl, per square centimeter
Amnio quad-core, per square centimeter
Amnio tri-core amniotic, per square centimeter
Rebound matrix, per square centimeter
Emerge matrix, per square centimeter
Amnicore pro, per square centimeter
Amnicore pro+, per square centimeter
Acesso tl, per square centimeter
Activate matrix, per square centimeter
Complete aca, per square centimeter
Complete aa, per square centimeter
Grafix plus, per square centimeter
American amnion ac tri-layer, per square centimeter
American amnion ac, per square centimeter
American amnion, per square centimeter
Sanopellis, per square centimeter
Via matrix, per square centimeter
Procenta, per 100 mg
Acesso, per square centimeter
Acesso ac, per square centimeter
Dermabind fm, per square centimeter
Reeva ft, per square cenitmeter
Regenelink amniotic membrane allograft, per square centimeter
Amchoplast, per square centimeter
Vitograft, per square centimeter
E-graft, per square centimeter
Sanograft, per square centimeter
Pellograft, per square centimeter
Renograft, per square centimeter
Caregraft, per square centimeter
Alloply, per square centimeter
Amniotx, per square centimeter
Acapatch, per square centimeter
Woundplus, per square centimeter
Duoamnion, per square centimeter
Most, per square centimeter
Singlay, per square centimeter
Total, per square centimeter
Axolotl graft, per square centimeter
Axolotl dualgraft, per square centimeter
Ardeograft, per square centimeter
Amnioplast 1, per square centimeter
Amnioplast 2, per square centimeter
Artacent c, per square centimeter
Artacent trident, per square centimeter
Artacent velos, per square centimeter
Artacent vericlen, per square centimeter
Simpligraft, per square centimeter
Simplimax, per square centimeter
Theramend, per square centimeter
Dermacyte ac matrix amniotic membrane allograft, per square centimeter
Tri-membrane wrap, per square centimeter
Shelter dm matrix, per square centimeter
Rampart dl matrix, per square centimeter
Sentry sl matrix, per square centimeter
Mantle dl matrix, per square centimeter
Palisade dm matrix, per square centimeter
Enclose tl matrix, per square centimeter
Overlay sl matrix, per square centimeter
Xceed tl matrix, per square centimeter
Palingen dual-layer membrane, per square centimeter
Abiomend xplus membrane and abiomend xplus hydromembrane, per square centimeter
Abiomend membrane and abiomend hydromembrane, per square centimeter
Xwrap plus, per square centimeter
Xwrap dual, per square centimeter
Choriply, per square centimeter
Amchoplast fd, per square centimeter
Epixpress, per square centimeter
Cygnus disk, per square centimeter
Amnio burgeon membrane and hydromembrane, per square centimeter
Amnio burgeon xplus membrane and xplus hydromembrane, per square centimeter
Amnio burgeon dual-layer membrane, per square centimeter
Dual layer amnio burgeon x-membrane, per square centimeter
Amniocore sl, per square centimeter
Amchothick, per square centimeter
Amnioplast 3, per square centimeter
Aeroguard, per square centimeter
Neoguard, per square centimeter
Amchoplast excel, per square centimeter
Membrane wrap lite, per square centimeter
Duograft ac, per square centimeter
Duograft aa, per square centimeter
Trigraft ft, per square centimeter
Renew ft matrix, per square centimeter
Amniodefend ft matrix, per square centimeter
Advograft one, per square centimeter
Advograft dual, per square centimeter
References
|
2020
Serena TE, Yaakov R, Moore S, et al. A randomized controlled clinical trial of a hypothermically stored amniotic membrane for use in diabetic foot ulcers. J Comp Eff Res. Jan 2020; 9(1): 23-34. PMID 31691579 |
|
2024
Cazzell SM, Caporusso J, Vayser D, et al. Dehydrated Amnion Chorion Membrane versus standard of care for diabetic foot ulcers: a randomised controlled trial. J Wound Care. Jul 01 2024; 33(Sup7): S4-S14. PMID 38973638 |
|
2018
Ananian CE, Dhillon YS, Van Gils CC, et al. A multicenter, randomized, single-blind trial comparing the efficacy of viable cryopreserved placental membrane to human fibroblast-derived dermal substitute for the treatment of chronic diabetic foot ulcers. Wound Repair Regen. May 2018; 26(3): 274-283. PMID 30098272 |
|
2019
Tettelbach W, Cazzell S, Sigal F, et al. A multicentre prospective randomised controlled comparative parallel study of dehydrated human umbilical cord (EpiCord) allograft for the treatment of diabetic foot ulcers. Int Wound J. Feb 2019; 16(1): 122-130. PMID 30246926 |
|
2018
DiDomenico LA, Orgill DP, Galiano RD, et al. Use of an aseptically processed, dehydrated human amnion and chorion membrane improves likelihood and rate of healing in chronic diabetic foot ulcers: A prospective, randomised, multi-centre clinical trial in 80 patients. Int Wound J. Dec 2018; 15(6): 950-957. PMID 30019528 |
|
2016
Snyder RJ, Shimozaki K, Tallis A, et al. A Prospective, Randomized, Multicenter, Controlled Evaluation of the Use of Dehydrated Amniotic Membrane Allograft Compared to Standard of Care for the Closure of Chronic Diabetic Foot Ulcer. Wounds. Mar 2016; 28(3): 70-7. PMID 26978860 |
|
2015
Zelen CM, Gould L, Serena TE, et al. A prospective, randomised, controlled, multi-centre comparative effectiveness study of healing using dehydrated human amnion/chorion membrane allograft, bioengineered skin substitute or standard of care for treatment of chronic lower extremity diabetic ulcers. Int Wound J. Dec 2015; 12(6): 724-32. PMID 25424146 |
|
2016
Zelen CM, Serena TE, Gould L, et al. Treatment of chronic diabetic lower extremity ulcers with advanced therapies: a prospective, randomised, controlled, multi-centre comparative study examining clinical efficacy and cost. Int Wound J. Apr 2016; 13(2): 272-82. PMID 26695998 |
|
2019
Tettelbach W, Cazzell S, Reyzelman AM, et al. A confirmatory study on the efficacy of dehydrated human amnion/chorion membrane dHACM allograft in the management of diabetic foot ulcers: A prospective, multicentre, randomised, controlled study of 110 patients from 14 wound clinics. Int Wound J. Feb 2019; 16(1): 19-29. PMID 30136445 |
|
2014
Lavery LA, Fulmer J, Shebetka KA, et al. The efficacy and safety of Grafix(®) for the treatment of chronic diabetic foot ulcers: results of a multi-centre, controlled, randomised, blinded, clinical trial. Int Wound J. Oct 2014; 11(5): 554-60. PMID 25048468 |
|
2014
Serena TE, Carter MJ, Le LT, et al. A multicenter, randomized, controlled clinical trial evaluating the use of dehydrated human amnion/chorion membrane allografts and multilayer compression therapy vs. multilayer compression therapy alone in the treatment of venous leg ulcers. Wound Repair Regen. 2014; 22(6): 688-93. PMID 25224019 |
|
2018
Bianchi C, Cazzell S, Vayser D, et al. A multicentre randomised controlled trial evaluating the efficacy of dehydrated human amnion/chorion membrane (EpiFix ® ) allograft for the treatment of venous leg ulcers. Int Wound J. Feb 2018; 15(1): 114-122. PMID 29024419 |
|
2019
Bianchi C, Tettelbach W, Istwan N, et al. Variations in study outcomes relative to intention-to-treat and per-protocol data analysis techniques in the evaluation of efficacy for treatment of venous leg ulcers with dehydrated human amnion/chorion membrane allograft. Int Wound J. Jun 2019; 16(3): 761-767. PMID 30864259 |
|
2022
Serena TE, Orgill DP, Armstrong DG, et al. A Multicenter, Randomized, Controlled, Clinical Trial Evaluating Dehydrated Human Amniotic Membrane in the Treatment of Venous Leg Ulcers. Plast Reconstr Surg. Nov 01 2022; 150(5): 1128-1136. PMID 36067479 |
|
2013
Suri K, Kosker M, Raber IM, et al. Sutureless amniotic membrane ProKera for ocular surface disorders: short-term results. Eye Contact Lens. Sep 2013; 39(5): 341-7. PMID 23945524 |
|
2013
Paris Fdos S, Gonçalves ED, Campos MS, et al. Amniotic membrane transplantation versus anterior stromal puncture in bullous keratopathy: a comparative study. Br J Ophthalmol. Aug 2013; 97(8): 980-4. PMID 23723410 |
|
2016
Sharma N, Thenarasun SA, Kaur M, et al. Adjuvant Role of Amniotic Membrane Transplantation in Acute Ocular Stevens-Johnson Syndrome: A Randomized Control Trial. Ophthalmology. Mar 2016; 123(3): 484-91. PMID 26686968 |
|
2004
Bouchard CS, John T. Amniotic membrane transplantation in the management of severe ocular surface disease: indications and outcomes. Ocul Surf. Jul 2004; 2(3): 201-11. PMID 17216092 |
|
2019
Liu J, Li L, Li X. Effectiveness of Cryopreserved Amniotic Membrane Transplantation in Corneal Ulceration: A Meta-Analysis. Cornea. Apr 2019; 38(4): 454-462. PMID 30702468 |
|
2020
Yin HY, Cheng AMS, Tighe S, et al. Self-retained cryopreserved amniotic membrane for treating severe corneal ulcers: a comparative, retrospective control study. Sci Rep. Oct 12 2020; 10(1): 17008. PMID 33046729 |
