Best practice for wound repair and regeneration use of cellular, acellular and matrix-like products (CAMPs)

Wu, Stephanie; Carter, Marissa J.; Cole, Windy; Crombie, Roselle; Kapp, Daniel; Kim, Paul; Milne, Catherine T.; Molnár, Joséph; Niezgoda, Jeffrey A.; Woo, Kevin; Zabel, David D.; Hamm, Rose; Armstrong, David; Bock, Alan J; Dheansa, Baljit; Driver, Vickie R.; Glat, Paul M.; Lantis, John C.; Ferreira, Lydia Masako; Melin, M. Mark; Patel, Keyur; Ricci, E; Simman, Richard; Steinberg, John S.; Tettelbach, William; Weir, Dot

doi:10.12968/jowc.2023.32.sup4b.s1

Cited by 24 publications

(7 citation statements)

References 97 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The USP <51> standard provides a well-accepted test method for evaluating the effectiveness of a material against a broad spectrum of microorganisms [18]. The seven microorganisms selected in this study were chosen because of their known pathogenicity, representing a comprehensive range of microbes typically found in the wound environment [1,[6][7][8][11][12]20]. Gjødsbøl et al (2006) conducted a retrospective clinical study on 46 patients with chronic leg ulcers [6].…”

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

“…Advanced matrices have been utilized in wound repair for decades [12]. These products may be cellular or acellular in nature and can be derived from either autologous, allogeneic, xenogeneic, or synthetic sources [12]. A synthetic, electrospun fiber matrix (SEFM) (Restrata®, Acera Surgical, Inc., St. Louis, MO) is a commercially available advanced matrix product [13] classified as a fully synthetic skin substitute by the Centers for Medicare and Medicaid Services.…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Antimicrobial Effectiveness Testing of Resorbable Electrospun Fiber Matrix per United States Pharmacopeia (USP) <51>

Sallade,

Grimes,

Jeng

et al. 2023

Cureus

View full text Add to dashboard Cite

Contamination of surgical, traumatic, and chronic wounds with microorganisms presents a challenge to successful wound healing. In the present in vitro study, a synthetic electrospun fiber matrix (SEFM) cleared for use in the management of chronic, surgical, and traumatic wounds underwent USP (United States Pharmacopeia) <51> Antimicrobial Effectiveness Testing to determine its in vitro effectiveness against various microorganisms commonly found in non-healing wounds. The SEFM was tested in both sheet (s-SEFM) and micronized form (m-SEFM) against Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, Aspergillus brasiliensis, Candida albicans, Proteus mirabilis, and Enterococcus faecalis. Testing was performed per the USP <51> standard on days 7, 14, and 28. Both the s-SEFM and m-SEFM met the USP <51> acceptance criteria for all microorganisms. The results obtained for s-SEFM demonstrated >1log 10 reduction against E. coli, S. aureus, P. aeruginosa, P. mirabilis, E. faecalis, and C. albicans at day 7; >3log 10 reduction with no detection of these microbes at days 14 and 28, and no increase from initial inoculum at days 7, 14, and 28 against A. brasiliensis. The results obtained for m-SEFM demonstrated >3log 10 reduction with no detectable microorganisms at day 7. The results observed in this study indicate that the SEFM is effective in vitro at inhibiting bacterial and fungal growth and colonization per USP <51> testing.

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Antimicrobial Effectiveness Testing of Resorbable Electrospun Fiber Matrix per United States Pharmacopeia (USP) <51>

Sallade,

Grimes,

Jeng

et al. 2023

Cureus

View full text Add to dashboard Cite

show abstract

“…As per a consensus document recently developed, CAMPs are defined as "a broad category of biomaterials, synthetic materials or biosynthetic matrices that support repair or regeneration of injured tissues through various mechanisms of action". 11 A recent report by the Agency for Healthcare Research and Quality (AHRQ) found that there are more than 70 approved skin substitutes in the management of DFUs. 12 Skin substitutes have recently been evaluated in four different systematic reviews and meta-analyses [13][14][15][16] and have been shown to be effective with favourable healing rates and reduced time to healing within [12][13][14][15][16] weeks.…”

Section: Introductionmentioning

confidence: 99%

“…Advanced wound care products such as skin substitutes otherwise known as cellular, acellular, and matrix‑like products (CAMPs) can be used adjunctively with standard care in the management of DFUs. As per a consensus document recently developed, CAMPs are defined as “a broad category of biomaterials, synthetic materials or biosynthetic matrices that support repair or regeneration of injured tissues through various mechanisms of action” 11 . A recent report by the Agency for Healthcare Research and Quality (AHRQ) found that there are more than 70 approved skin substitutes in the management of DFUs 12 .…”

Section: Introductionmentioning

confidence: 99%

Cost effectiveness analysis for commonly used human cell and tissue products in the management of diabetic foot ulcers

Nherera,

Banerjee

2024

Health Science Reports

View full text Add to dashboard Cite

Background and AimsThis study considers the cost‐effectiveness of commonly used cellular, acellular, and matrix‑like products (CAMPs) of human origin also known as human cell and tissue products (HCT/Ps) in the management of diabetic foot ulcers.MethodsWe developed a 1‐year economic model assessing six CAMPs [cryopreserved placental membrane with viable cells (vCPM), bioengineered bilayered living cellular construct (BLCC), human fibroblast dermal substitute (hFDS), dehydrated human amnion chorion membrane (dHACM), hypothermically stored amniotic membrane (HSAM) and human amnion membrane allograft (HAMA) which had randomized controlled trial evidence compared with standard of care (SoC). CAMPs were compared indirectly and ranked in order of cost‐effectiveness using SoC as the baseline, from a CMS/Medicare's perspective.ResultsThe mean cost, healed wounds (hw) and QALYs per patient for vCPM is $10,907 (0.914 hw, 0.783 QALYs), for HAMA $11,470 (0.903 hw, 0.780 QALYs), for dHACM $15,862 (0.828 hw, 0.764 QALYs), for BLCC $18,430 (0.816 hw, 0.763 QALYs), for hFDS $19,498 (0.775 hw, 0.757 QALYs), for SoC $19,862 (0.601 hw, 0.732 QALYs) and $24, 214 (0.829, 0.763 QALYs) for HSAM respectively. Over 1 year, vCPM results in cheaper costs overall and better clinical outcomes compared to other CAMPs. Following probabilistic sensitivity analysis, vCPM has a 60%, HAMA 40% probability of being cost‐effective then dHACM, hFDS, BLCC, and lastly HSAM using a $100,000/healed wound or QALY threshold.ConclusionsAll CAMPs were shown to be cost‐effective when compared to SoC in managing DFUs. However, vCPM appears to be the most cost‐effective CAMP over the modelled 52 weeks followed by HAMA, dHACM, hFDS, BLCC, and HSAM. We urge caution in interpreting the results because we currently lack head‐to‐head evidence comparing all these CAMPs and therefore suggest that this analysis be updated when more direct evidence of CAMPs becomes available.

show abstract

Assessing placental membrane treatment efficiency in diabetic foot ulcers: Processing for retention versus lamination

Frykberg,

Tunyiswa

2024

Health Science Reports

View full text Add to dashboard Cite

BackgroundDiabetic foot ulcers are a severe complication in diabetic patients, significantly impact healthcare systems and patient quality of life, often leading to hospitalization and amputation. Traditional Standard of Care (SOC) treatments are inadequate for many patients, necessitating advanced wound care products (AWCPs) like human placental membranes. This study conducts a retrospective analysis to compare the effectiveness of two human placental membrane products, retention‐processed amnion chorion (RE‐AC) and lamination‐processed amnion chorion (L‐AC) in managing chronic diabetic foot ulcers (DFUs).MethodsThe study collected retrospective observational data from electronic health records (EHRs) of patients treated for DFU at three outpatient wound care centers. Patients were categorized into two cohorts based on the treatment received. Key metrics included wound size progression and the number of product applications. The analysis employed Bayesian estimation, utilizing an analysis of covariance model with a Hurdle Gamma likelihood.ResultsWe found that RE‐AC achieved a marginally higher expected Percent Area Reduction (xPAR) in DFUs compared to L‐AC at 12 weeks (67.3% vs. 52.6%). RE‐AC also required fewer applications, suggesting greater efficiency in general wound closure. Probability of full wound closure was similar in both groups (0.738 vs 0.740 in RE‐AC and L‐AC, respectively).ConclusionThe findings suggest that while L‐AC might be slightly more effective in complete ulcer healing, RE‐AC offers overall better treatment efficiency, especially in reducing the frequency of applications. This efficiency can lead to improved patient comfort, reduced treatment costs, and optimized resource utilization in healthcare settings.

show abstract

Best practice for wound repair and regeneration use of cellular, acellular and matrix-like products (CAMPs)

Cited by 24 publications

References 97 publications

Antimicrobial Effectiveness Testing of Resorbable Electrospun Fiber Matrix per United States Pharmacopeia (USP) <51>

Antimicrobial Effectiveness Testing of Resorbable Electrospun Fiber Matrix per United States Pharmacopeia (USP) <51>

Cost effectiveness analysis for commonly used human cell and tissue products in the management of diabetic foot ulcers

Assessing placental membrane treatment efficiency in diabetic foot ulcers: Processing for retention versus lamination

Contact Info

Product

Resources

About