Why Processing Method Matters
Amniotic membrane allografts have been used in wound care for over a century, with applications expanding from ophthalmology into diabetic foot ulcers (DFU), venous leg ulcers (VLU), pressure injuries, and surgical wounds. The fundamental biological value of amniotic tissue is well characterized: a collagen-rich extracellular matrix (ECM) scaffold delivering growth factors, tissue inhibitors of metalloproteinases (TIMPs), and immunomodulatory cytokines that support granulation, angiogenesis, and re-epithelialization. But not all amniotic membrane products deliver the same biological payload — or the same logistical profile.
Processing method is the single largest variable determining what arrives at the point of care. Dehydration and cryopreservation produce grafts with meaningfully different growth factor retention profiles, ECM architectures, storage requirements, preparation workflows, and cost structures. Understanding these differences allows clinicians and procurement teams to select the right product for the right clinical scenario — rather than defaulting to whatever is in the freezer.
Processing Methods: What Happens to the Tissue
Dehydrated Amniotic Membrane
Dehydration removes water from amniotic tissue through controlled drying — typically vacuum-drying at ambient or mildly elevated temperatures — without a pre-freeze step. This is distinct from lyophilization (freeze-drying), which freezes the tissue before sublimating water under vacuum. The absence of freezing in dehydration avoids ice-crystal damage to the ECM architecture that can occur during lyophilization [1].
Aseptically processed dehydrated membranes undergo disinfection (commonly peracetic acid / ethanol) without terminal sterilization. Some dehydrated products receive terminal gamma irradiation or e-beam sterilization; the latter has been associated with collagen fiber disruption and basement membrane fragmentation [2]. Products that combine aseptic processing with dehydration — avoiding both freeze damage and irradiation damage — retain more native ECM architecture and growth factor bioavailability [1, 2].
Storage and handling: Room-temperature storage. No cold chain. Shelf life typically 2–3 years in sealed packaging. Dry application (hydrated by wound exudate) or brief saline hydration before placement, depending on the specific product.
Cryopreserved Amniotic Membrane
Cryopreservation uses controlled-rate freezing with cryoprotectants (typically glycerol or DMSO) to preserve tissue at −80°C or in liquid nitrogen. The goal is to halt biological activity while minimizing ice-crystal damage to cell membranes and collagen architecture. Cryopreserved products retain viable cells in both the stromal and epithelial layers, which continue to secrete growth factors and cytokines after thawing [2, 3].
Storage and handling: Continuous frozen storage at −80°C or liquid nitrogen. Cold-chain shipping with temperature monitoring. Thawing protocol required before application (typically 10–15 minutes in sterile saline at room temperature). Once thawed, the graft must be applied promptly; shelf life after thawing is measured in hours.
Growth Factor Retention and ECM Integrity
The biological activity of amniotic membrane depends on the quantity and bioavailability of growth factors retained after processing — including epidermal growth factor (EGF), hepatocyte growth factor (HGF), transforming growth factor-beta (TGF-β), fibroblast growth factor (bFGF), keratinocyte growth factor (KGF), and platelet-derived growth factor (PDGF-AA) — as well as the structural integrity of the collagen ECM and basement membrane [4, 5].
Allen et al. (2013) compared cryopreserved versus dried amniotic membrane across structural, biochemical, and cellular endpoints [1]. Dried AM — with and without saccharide lyoprotectants (trehalose, raffinose) — outperformed cryopreserved AM across multiple measures:
- Growth factor retention: Dried AM retained significantly higher levels of stromal-soluble factors including IL-8, KGF, and TGF-β1, and stromal-insoluble factors including EGF, HGF, and BDNF. Cryopreserved AM showed marked decreases — HGF dropped from 34 to 5.3 ng/mg total protein compared to fresh tissue [1].
- Sustained release: Dried AM released biological factors more sustainably than cryopreserved AM over time, suggesting prolonged therapeutic activity at the wound bed. ELISA analysis of cumulative wash-leached EGF confirmed higher retention efficiency in dried versus cryopreserved samples [1].
- Structural integrity: Cryopreserved AM showed loss of amniotic epithelial cell (AEC) polygonal shape, surface fissures, and disorganized, vacuolated epithelial layer on electron microscopy. Trehalose-pre-treated dried AM was most similar to fresh tissue in AEC morphology, with limited surface and microvillus damage [1].
- Biocompatibility: Dried AM with lyoprotectants was superior to cryopreserved AM in corneal epithelial cell proliferation, reduced LDH release, reduced caspase-3 activity (apoptosis marker), and improved wound healing in cellular migration assays [1].
Conversely, Cooke et al. (2014) reported that cryopreservation better preserved the structural integrity and biological signaling molecules of fetal tissues compared to dehydrated amnion/chorion products in a direct analytical comparison [2]. The discrepancy between studies likely reflects differences in dehydration protocols — the Allen study used vacuum drying without pre-freezing with optimized lyoprotectants, while the dehydrated products analyzed by Cooke may have used terminal sterilization (gamma irradiation), which independently damages ECM proteins.
The 2023 review by Ingraldi et al. underscores the central point: processing methods are not standardized across the industry, and products with the same label (e.g., "dehydrated amniotic membrane") can differ substantially in growth factor content, ECM architecture, and clinical performance depending on the specific manufacturing protocol [6].
Clinical Evidence by Wound Type
Diabetic Foot Ulcers (DFU)
Dehydrated: Zelen et al. (2013) demonstrated significantly higher complete wound closure rates at 12 weeks for DFUs treated with dehydrated human amnion/chorion membrane (dHACM) plus standard of care (SOC) versus SOC alone in a prospective randomized comparative parallel study [7]. Zelen et al. (2015) extended these findings in a multi-center comparative effectiveness trial showing dHACM outperformed both a bioengineered skin substitute and SOC alone for chronic lower-extremity diabetic ulcers [8].
A dual-layer amniotic membrane (DLAM) observational study reported complete wound closure at 12 weeks in 17 of 26 DFU patients (65%), with a mean baseline ulcer size of 4.65 ± 4.89 cm² — notably larger than typical DFU trial enrollment thresholds, suggesting activity in more resistant wounds [9].
Cryopreserved: Randomized controlled trial data for cryopreserved amniotic membrane specifically in DFU populations are more limited than for dehydrated products. A randomized trial (NCT03754218) evaluating cryopreserved amniotic membrane in DFU has been completed but full results are pending publication as of mid-2026. Clinicians evaluating cryopreserved AM for DFU should review product-specific clinical evidence from the manufacturer.
Venous Leg Ulcers (VLU)
Dehydrated: Serena et al. (2022) conducted a multicenter RCT (n = 60) evaluating aseptically processed dehydrated human amnion/chorion allograft (dHACA) applied weekly or biweekly plus multilayer compression versus compression alone for chronic VLUs [10]. Healing at 12 weeks was 75% in the combined dHACA groups versus 30% in SOC alone (p = 0.001), with an adjusted odds ratio of 8.7 (95% CI, 2.2–33.6). Notably, there was no significant difference between weekly and biweekly application, suggesting flexibility in treatment frequency.
Psathas et al. (2024) reported outcomes from a real-world wound-center registry of dehydrated amnion/chorion membrane with preserved spongy layer (dHACM/SL): 71.7% of 53 chronic wounds achieved favorable outcomes (>70% area reduction), and 66% achieved complete healing at a median of 77 days. VLUs specifically showed 75% favorable outcomes. Wound chronicity was a significant predictor — wounds present <12 months were significantly more likely to achieve favorable outcomes (OR = 3.378, p = 0.005) [11].
Cryopreserved: Horvath et al. (2024) reported a case series of cryopreserved amniotic membrane in five polymorbid patients with nine chronic nonhealing wounds (primarily CVI and PAD etiologies). Complete healing was achieved in three of five patients (six of nine wounds) with cryopreserved AM applied weekly for the first month then biweekly. Pain relief was noted in all patients. Treatment failures were associated with poor compliance, persistent edema, or bacterial colonization [12].
Pressure Injuries
Cryopreserved: A randomized controlled trial compared cryopreserved human amniotic membrane allograft plus routine care versus routine care alone for pressure ulcers [13]. The cryopreserved AM group demonstrated significantly faster healing. (Full trial details behind reCAPTCHA at PMC5694597.)
Dehydrated: Psathas et al. (2024) reported 66% complete healing for pressure injuries treated with dHACM/SL, though the pressure injury subgroup was small (n = 3 wounds) [11]. Dehydrated products are available for pressure injury protocols; clinicians should evaluate product-specific evidence.
Surgical Wounds
Dehydrated: In the Psathas et al. (2024) cohort, surgical wounds demonstrated 75% favorable outcomes with dHACM/SL, comparable to VLU and trauma wound outcomes. The product was applied weekly following a standardized protocol of debridement, direct membrane placement, and nonadherent secondary dressing [11].
Cryopreserved: Cryopreserved amniotic membrane has established use in ophthalmic surgery (corneal surface reconstruction), where it serves as a basement membrane substrate for epithelial migration. Its use in dermal surgical wounds is supported by case series and institutional protocols rather than large-scale RCTs [6].
Application Technique Differences
While application technique is fundamentally similar across formats — debridement, sizing, placement, secondary dressing — preparation workflow differs meaningfully.
| Application Step | Dehydrated | Cryopreserved |
|---|---|---|
| Pre-application preparation | Open sterile package. Dry application (hydrated by wound exudate) or brief saline hydration, per product IFU. Time: <1 minute. | Remove from freezer. Thaw per protocol (typically 10–15 minutes in sterile saline at room temperature). Rinse to remove cryoprotectant if required. Time: 10–20 minutes. |
| Wound bed preparation | Sharp debridement to remove nonviable tissue and biofilm. Hemostasis. Wound bed should be clean and granular. | Sharp debridement to remove nonviable tissue and biofilm. Hemostasis. Wound bed should be clean and granular. |
| Graft sizing and placement | Sized to wound margins. Sheet grafts placed directly on wound bed. May be fenestrated to allow exudate drainage. Micronized formulations injected or applied into irregular contours. | Sized to wound margins. Sheet grafts placed directly on wound bed. May be meshed if indicated. Place stromal side toward wound bed (sidedness matters; epithelial side has anti-angiogenic properties [6]). |
| Secondary dressing | Nonadherent contact layer (silicone or petrolatum-impregnated gauze). Absorbent secondary dressing. Compression for VLUs when indicated. Offloading for DFUs. | Nonadherent contact layer. Absorbent secondary dressing. Compression for VLUs when indicated. Offloading for DFUs. |
| Reapplication interval | Weekly or biweekly, depending on product, exudate level, and wound trajectory. Serena et al. (2022) found no significant difference between weekly and biweekly dHACA application for VLUs [10]. | Weekly for the first month, then biweekly based on clinical response, per published protocols [12]. |
| Graft retention | Membrane integrates with wound bed over days. Do not disturb between applications. If graft is displaced, evaluate wound bed and reapply per clinical judgment. | Membrane integrates with wound bed over days. Do not disturb between applications. Left in place ≥48 hours between applications [12]. |
Reimbursement and Coding: The 2026 CMS Landscape
Effective January 1, 2026, CMS fundamentally restructured skin substitute reimbursement under the CY 2026 Physician Fee Schedule final rule. Amniotic membrane products, previously paid under an ASP-based methodology (treated as biologic/drug equivalents), are now reclassified as "wound care management" products and reimbursed as incident-to supplies under the Physician Fee Schedule or hospital outpatient system [14].
Key changes affecting amniotic membrane product selection:
- Site-neutral payment: Reimbursement is now aligned across physician office, hospital outpatient department (HOPD), and ambulatory surgery center (ASC) settings. The same product receives the same payment regardless of site of service [14].
- Product grouping by regulatory pathway: CMS groups products as HCT/P, 510(k), or PMA. Amniotic membrane allografts regulated as HCT/Ps under PHS Act Section 361 fall within the HCT/P grouping. Product-specific Q-codes (Q4xxx series) and application CPT codes (15271–15278) remain the billing mechanism [14].
- Documentation requirements: CMS explicitly ties documentation to medical necessity: "Adequate clinical documentation must support the medical necessity, appropriateness, and frequency of the skin substitute application" [14]. Standard-of-care failure before initiating skin substitutes, consistent wound measurements and imaging, and clear progress metrics (time to 50% reduction, visits to closure) are now non-negotiable.
- Per-application cost considerations: The reclassification to incident-to supplies reduces per-application payment relative to the previous ASP-based methodology. For procurement decision-makers, the total cost of a treatment episode now reflects product cost plus — crucially — logistics and labor. Dehydrated products avoid freezer acquisition and maintenance costs, cold-chain shipping surcharges, and thawing labor time. Cryopreserved products add these operational costs to the per-application total.
Product Comparison Table
| Criterion | Dehydrated Amniotic Membrane | Cryopreserved Amniotic Membrane |
|---|---|---|
| Processing | Controlled vacuum or air drying. No freezing step. Aseptically processed (peracetic acid / ethanol) or terminally sterilized (gamma, e-beam). | Controlled-rate freezing with cryoprotectants (glycerol, DMSO). Stored at −80°C or in liquid nitrogen. |
| Growth factor retention | Varies by protocol. Optimized dehydration with lyoprotectants outperformed cryopreserved AM for EGF, HGF, TGF-β1, and KGF retention in laboratory analysis [1]. Gamma-irradiated products show reduced factor levels [2]. | Retains native ECM architecture and signaling molecules [2]. Viable cells continue factor secretion post-thaw. Some soluble factors decrease during cryopreservation [1]. |
| ECM architecture | Protocol-dependent. Aseptically processed, non-irradiated products retain more native structure. Irradiation associated with collagen disruption and basement membrane fragmentation [2]. | Well-preserved collagen architecture and basement membrane integrity. Some AEC surface damage visible on electron microscopy [1]. |
| Cellular viability | Dehydration devitalizes amniotic epithelial cells. Graft functions as an acellular ECM scaffold with bound growth factors. | Retains viable stromal and epithelial cells that continue bioactive factor secretion after thawing and application [2, 3]. |
| Storage | Room temperature. No cold chain required. | Continuous frozen storage at −80°C or liquid nitrogen. Cold-chain shipping with temperature monitoring required. |
| Shelf life | 2–3 years in sealed packaging. | Months to 2 years frozen. Once thawed: hours. |
| Preparation time | <1 minute: open, optionally hydrate, apply. | 10–20 minutes: thaw, rinse, apply. |
| DFU evidence (RCT) | Multiple RCTs: Zelen 2013 [7], Zelen 2015 [8]. DLAM observational data: 65% closure at 12 weeks [9]. | Limited published RCT data specific to DFU as of mid-2026. Product-specific evidence should be requested from manufacturer. |
| VLU evidence (RCT) | Serena 2022: 75% healing at 12 weeks vs 30% SOC (p = 0.001) [10]. | Case series and small RCTs show activity in refractory VLUs [12, 13]. Large-scale RCT data pending. |
| Operational complexity | Low. No freezer infrastructure. Minimal preparation. Suited to outpatient clinics, mobile wound services, satellite locations. | Moderate-to-high. Requires −80°C freezer on site, temperature monitoring, thawing protocol, and timely post-thaw application. |
| Per-application cost (total) | Product cost only. No cold-chain logistics cost, no freezer maintenance, minimal labor for preparation. | Product cost + cold-chain shipping + freezer acquisition/maintenance + thawing labor time. Freezer failure may result in product loss. |
| Best-fit operational setting | Outpatient wound centers, podiatry clinics, mobile wound services, ASCs with limited freezer capacity, high-volume practices where preparation time matters. | Hospital-based wound centers with existing −80°C infrastructure, academic medical centers, surgical settings where on-site freezer is standard. |
Clinical Scenario Recommendations
The following recommendations reflect the synthesis of published clinical evidence, operational considerations, and CMS reimbursement context as of mid-2026. These are decision-support suggestions, not mandates. Clinical judgment, institutional protocols, and individual product IFUs should guide final product selection.
| Clinical Scenario | Suggested Format | Rationale |
|---|---|---|
| DFU with granulation deficit, outpatient wound center, no on-site −80°C freezer | Dehydrated dual-layer sheet graft | Multiple RCTs support DFU healing with dehydrated amniotic membrane [7, 8]. Room-temperature storage eliminates freezer infrastructure requirement. Dual-layer products (amnion-amnion or amnion-chorion) provide thicker ECM scaffold for weight-bearing surfaces. |
| DFU, hospital-based wound center with −80°C capacity, wound >12 months refractory to SOC | Cryopreserved sheet graft | Hospital setting supports cold chain. Cryopreserved products retain viable cells for ongoing factor secretion — biologically compelling for indolent wounds. However, note the Psathas finding that wound chronicity >12 months reduces favorable outcome probability across all formats [11]. |
| VLU, compression-tolerant, outpatient setting, no cold chain | Dehydrated amnion/chorion sheet graft | Serena 2022 provides Level I evidence for dehydrated HACA in VLU: 75% healing at 12 weeks versus 30% SOC (OR = 8.7) [10]. Room temperature storage. Biweekly application supported by trial data, reducing visit frequency. |
| VLU, compression-tolerant, hospital-based, cold chain available | Either format — clinician preference | Both formats have clinical evidence of activity in VLUs. If cold chain exists and preparation time is acceptable, cryopreserved grafts offer viable-cell factor secretion. If faster preparation and lower logistics burden are priorities, dehydrated grafts are equally evidence-supported. |
| Pressure injury, stage 3–4, hospital inpatient | Cryopreserved sheet graft (if freezer on site) or dehydrated sheet graft | Cryopreserved AM has RCT data in pressure injuries [13]. Dehydrated products are logistically simpler for bedside application in units without freezer access. Both formats show clinical activity. |
| Surgical wound dehiscence, in-hospital post-operative | Cryopreserved sheet graft | On-site freezer is standard in surgical settings. Maximum ECM and growth factor delivery supports healing in fresh surgical wounds. Ophthalmic surgery experience provides decades of safety data for cryopreserved AM on surgically prepared wound beds [6]. |
| Mobile wound service / home-based wound care | Dehydrated sheet graft or micronized formulation | No cold chain feasible in mobile/home setting. Dehydrated products are room-temperature stable and ready to apply in under one minute. Micronized formulations can address tunneling and undermining without sheet-graft sizing constraints. |
| High-volume wound center, mixed wound types, budget-conscious procurement | Dehydrated dual-layer sheet graft | Room-temperature inventory management eliminates freezer capital costs, ongoing electricity, and temperature-monitoring compliance. Evidence base covers DFU, VLU, pressure injuries, and surgical wounds [7–11]. Established CMS reimbursement pathway under 2026 incident-to supply framework [14]. |
| Wound with tunneling, undermining, or irregular contours | Micronized / flowable amniotic formulation (either format) | Micronized products can be injected or instilled into spaces that sheet grafts cannot reach. Both dehydrated and cryopreserved flowable formulations exist. Select based on storage availability and manufacturer evidence specific to the wound type. |
| Large surface-area wound (≥25 cm²) | Dehydrated dual-layer sheet graft | Dual-layer products (amnion-chorion or amnion-amnion) provide greater tensile strength and ECM surface area for large wounds. Psathas 2024 included wounds up to 50.5 cm² with successful outcomes [11]. Verify product size availability with manufacturer. |
How Processing Method Should (and Should Not) Drive Clinical Decisions
Processing method is one of several factors in product selection — alongside wound etiology, wound-bed characteristics, clinical setting, payer mix, and institutional protocols. It should not be the sole determinant.
Processing method should drive decisions when:
- Cold-chain infrastructure is absent or unreliable (favors dehydrated).
- Preparation time is a binding operational constraint (dehydrated is faster).
- Viable-cell factor secretion is a specific therapeutic goal (cryopreserved retains viable cells).
- Product-specific RCT data exists for the target wound type (as of mid-2026, dehydrated has a larger published DFU and VLU RCT base).
- Total cost per application — including logistics and labor — is a procurement priority (dehydrated eliminates cold-chain costs).
Processing method should not drive decisions when:
- A particular product within either category has superior wound-type-specific RCT data (product-level evidence trumps category-level assumptions).
- Institutional protocols, group purchasing agreements, or payer coverage policies specify a particular product.
- The clinical team has greater experience and comfort with one format, and outcomes data support that preference.
- A product configuration (micronized vs sheet, single-layer vs dual-layer) better matches the wound anatomy, regardless of how it was preserved.
Key Takeaways
- Dehydrated and cryopreserved amniotic membrane allografts provide ECM scaffold and growth factor delivery via different processing routes, each with distinct biological and logistical profiles.
- Optimized dehydration protocols using saccharide lyoprotectants and aseptic processing (no terminal irradiation) have demonstrated superior growth factor retention and sustained release compared to cryopreserved AM in laboratory analysis [1]. These findings are protocol-specific and not generalizable to all dehydrated products.
- Cryopreserved AM retains viable cells that continue to secrete growth factors after thawing, and preserves native ECM architecture and basement membrane integrity [2, 3].
- The dehydrated format has the larger published RCT evidence base as of mid-2026 — including multiple DFU trials by Zelen and colleagues [7, 8] and the Serena 2022 VLU RCT [10]. Cryopreserved AM has RCT evidence in pressure injuries [13] and case-series evidence across wound types [12].
- No head-to-head RCT has compared dehydrated versus cryopreserved AM in the same wound-type population. Category-level superiority claims are not supported by published evidence.
- The 2026 CMS skin substitute reclassification to incident-to supplies makes operational costs — cold chain, freezer maintenance, preparation labor — a larger share of total episode cost than under previous ASP-based payment [14]. Dehydrated products eliminate these operational costs.
- Product selection should integrate wound characteristics, clinical setting, cold-chain availability, per-application cost, payer coverage, and product-specific evidence — not processing method alone.
References
- Allen CL, Clare G, Stewart EA, et al. Augmented dried versus cryopreserved amniotic membrane as an ocular surface dressing. PLoS ONE. 2013;8(10):e78441. doi:10.1371/journal.pone.0078441. PMCID: PMC3813584. PMID: 24205233.
- Cooke M, Tan EK, Mandrycky C, et al. Comparison of cryopreserved amniotic membrane and umbilical cord tissue with dehydrated amniotic membrane/chorion tissue. J Wound Care. 2014;23(10):465–474. doi:10.12968/jowc.2014.23.10.465. PMID: 25296347.
- Popescu A, Petri L, Gherghiceanu M, et al. Cryopreserved amniotic membrane as transplant allograft: viability and post-thaw characterization by confocal microscopy. Cell Tissue Bank. 2015;17:543–551. PMID: 26361949.
- Koob TJ, Rennert R, Zabek N, et al. Biological properties of dehydrated human amnion/chorion composite graft: implications for chronic wound healing. Int Wound J. 2013;10(5):493–500.
- Koob TJ, Lim JJ, Zabek N, Massee M. Cytokines in single layer amnion allografts compared to multilayer amnion/chorion allografts for wound healing. J Biomed Mater Res B Appl Biomater. 2015;103(5):1133–1140.
- Ingraldi AL, Audet RG, Tabor AJ. The preparation and clinical efficacy of amnion-derived membranes: a review. J Funct Biomater. 2023;14(10):531. doi:10.3390/jfb14100531. PMCID: PMC10607219.
- Zelen CM, Serena TE, Denoziere G, Fetterolf DE. A prospective randomised comparative parallel study of amniotic membrane wound graft in the management of diabetic foot ulcers. Int Wound J. 2013;10(5):502–507. PMID: 23742102.
- 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. 2015;12(6):724–732. PMID: 25424146.
- Use of a dual-layer amniotic membrane in the treatment of diabetic foot ulcers: an observational study. J Wound Care. 2020;29(Suppl 9):S12–S18. PMID: 32924804.
- 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. 2022;150(5):1128–1136. doi:10.1097/PRS.0000000000009650. PMCID: PMC9586828.
- Psathas E, Egger B, Mayer D. Dehydrated human amnion/chorion membrane allograft with spongy layer to significantly improve the outcome of chronic non-healing wounds. Int Wound J. 2024;21(1):e14356. doi:10.1111/iwj.14356. PMCID: PMC10781888.
- Horvath V, Svobodova A, Cabral JV, et al. Cryopreserved amniotic membrane in chronic nonhealing wounds: a series of case reports. Cell Tissue Bank. 2024;25:325–337. doi:10.1007/s10561-023-10100-5. PMCID: PMC10901998. PMID: 37945942.
- Grafting with cryopreserved amniotic membrane versus conventional wound care for pressure ulcers: a randomized controlled clinical trial. PMCID: PMC5694597.
- CMS. CY 2026 Physician Fee Schedule Final Rule: Skin Substitute Reclassification and Payment Methodology. Federal Register. 2025. Available at: https://www.cms.gov/newsroom/press-releases/cms-modernizes-payment-accuracy-significantly-cuts-spending-waste
- Koob TJ, Lim JJ, Massee M, et al. Properties of dehydrated human amnion/chorion composite grafts: implications for wound repair and tissue regeneration. J Biomed Mater Res B Appl Biomater. 2014;102(6):1353–1362.
- Zelen CM, Serena TE, Fetterolf DE. Dehydrated human amnion/chorion membrane allografts in patients with chronic diabetic foot ulcers: a long-term follow-up study. Wound Medicine. 2014;4:1–4.
- 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. 2014;11(5):554–560.
- Serena TE, Carter MJ, Le LT, et al. A multi-center 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. 2021;29(1):106–112.
Related Resources
- Antimicrobial Matrices vs Biologic Allografts — Technology comparison for wound clinicians
- AmnioAMP vs Rampart: Product Comparison — Side-by-side comparison of NextGen's amniotic membrane allografts
- AmnioAMP Application Protocol — Step-by-step guide for wound care teams
- Medicare Coverage for Advanced Wound Biologics — Eligibility criteria, HCPCS coding, and 2026 reimbursement updates
- NextGen Wound Biologics Product Portfolio
Evaluate Dehydrated Dual-Layer Amniotic Membrane for Your Wound Care Protocol
Rampart Dual Layer Matrix is a room-temperature-stable dehydrated amniotic membrane allograft designed for weekly or biweekly application across a range of chronic wound etiologies. AmnioAMP-MP provides a micronized amniotic solution for wounds with tunneling, undermining, or irregular contours. Request product samples and clinical evidence for appropriate evaluation.
Request samples at nextgenbiologicsusa.com/request-samples