ABSTRACT
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.
Subject(s)
Amnion , Chorion , Diabetic Foot , Standard of Care , Wound Healing , Humans , Diabetic Foot/therapy , Female , Amnion/transplantation , Male , Chorion/transplantation , Middle Aged , Prospective Studies , Aged , Treatment Outcome , Adult , Biological DressingsABSTRACT
With increased awareness, both in the dental literature and by the general public, of peri-implant disease, a growing trend in dentistry is to save teeth with a "questionable" periodontal prognosis. This prospective study involving such patients was designed to evaluate the effects of combining a bioactive barrier and graft, not on the socket but to augment adjacent periodontal conditions on teeth with severe periodontal bone loss at the time of extraction of an adjacent tooth. Fifteen patients were selected; teeth were extracted, ground, prepared with a pH 11 cleanser, partially demineralized, and made into a graft. This mixture was used to augment socket volume and perform periodontal regenerative surgery. The graft was covered with a bioactive amnion-chorion barrier membrane. Bioactive membranes can stimulate host cells in the surrounding gingival and periosteal tissues to accelerate site closure and healing, simultaneously exerting positive effects on the underlying bone and graft material not observed to the same extent with other membranes. This can improve healing and site regeneration as shown clinically and radiographically in this report. Use of these bioactive barrier membrane and dentin graft materials may have additive effects and provide stimulus for conversion to host bone after site healing. The combination of an amnion-chorion membrane with autologous dentin graft appears to maximize the benefits of the individual materials, improving guided tissue regeneration results and the prognoses of periodontally involved teeth.
Subject(s)
Amnion , Chorion , Dentin , Tooth Extraction , Humans , Amnion/transplantation , Prognosis , Prospective Studies , Chorion/transplantation , Middle Aged , Female , Adult , Male , Alveolar Bone Loss/surgery , Guided Tissue Regeneration, Periodontal/methods , AgedABSTRACT
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Subject(s)
Humans , Skin Ulcer/therapy , Pressure Ulcer/therapy , Amnion/transplantation , Allografts/transplantation , Chorion/transplantation , Treatment OutcomeABSTRACT
Se realizó un estudio prospectivo y observacional de 25 pacientes portadores de esguince de tobillo grado III, todos con evidencia clínica y radiológica de lesión cápsulo-ligamentaria, los cuales requirieron de tratamiento quirúrgico, a base de la plastía ligamentaria con corion de piel, para la substitución del ligamento peroneo estragalino anterior, reportando resultados satisfactorios en las revisiones, subsecuentes, en un promedio de cuatro meses