Evaluation of the Effectiveness of Amniotic Membrane Extract in the Experimental Wound Model of Skin

Project no. 30746 · Status: Kapanmış · 2023

Summary

OBJECTIVE: Wound care is a principal subject in plastic, reconstructive, and aesthetic surgery where effective treatment is critical to prevent potential secondary complications. Efforts in development of practical and cost-effective products for wound care continues vigorously due to factors such as the rising costs of wound care and challenges in the surgical treatment of patients with comorbid conditions. The efficacy of human amniotic membrane (hAM) application on wound healing has been known for many years. With the aim of making this treatment more practical and due to limitations in the acquisition and storage of hAM, the idea of extracting this biological material emerged. Globally, research is conducted on this topic; however, there is no consensus on the best extraction method or application dosage. This study aims to investigate the effectiveness of the amniotic membrane extract (AME), developed through R&D at the Department of Ophthalmology of our university's Medical Faculty, applied in a clinically correlated dose in an experimental skin wound model in comprasion with traditional amniotic membrane transplantation (AMT).MATERIALS AND METHODS: The study utilized cryopreserved hAM and lyophilized-sterile AME drops, obtained from the Ocular Surface Research Laboratory at Ege University. The study included 16 albino Wistar rats divided into three groups: Group 1 (n=6) underwent AMT, Group 2 (n=6) received AME, and Group 3 (n=4) served as the control. A full-thickness circular skin defect with a 1.5 cm radius was created on the dorsal surface of all rats. In Group 1, a 4x4 cm AMT was applied, while in Group 2, an AME drop with an equivalent total protein ratio to that of the amniotic membrane was used. Group 3 was treated only with a gauze pad containing petrolatum and chlorhexidine. Clinical follow-up was conducted through photography throughout the monitoring period, and on day 21, the animals were sacrificed, and the wound sites were excised for histopathological evaluation.RESULTS: No infections or bleeding complications developed in any of the groups. Clinical evaluations on days 7 and 14 showed that Group 1 had a smoother wound surface and thinner scab formation compared to the other groups. Clinically, Group 3 displayed a greater crust thickness than Group 2. Histopathological examination on day 21 revealed that the crust thickness in Group 1 was significantly thinner compared to the other groups. While no statistically significant differences were observed in other histopathological parameters, Group 2 exhibited the lowest scores in terms of increased vascularization, fibrosis, and edema. Inflammatory cell infiltration was less observed in Groups 1 and 2 compared to the control group. Bacterial colonization was almost non-existent in Group 1.CONCLUSION: AME, a biologically derived therapeutic product, is extracted from hAM. Despite the lack of global consensus on its preparation, storage, and dosing, this study investigated the effects of AME, which has been standardized within our university to have a fixed protein content and is both sterile and lyophilized. This is the first time in the literature that AME has been applied in a clinically correlated dosage in an experimental skin wound model. The data indicate that AME shares similar therapeutic properties with AMT in promoting wound healing, yet offers advantages in terms of storage and ease of use. This thesis represents the first study to compare clinically correlated dosage adjustments of AME with AMT in the treatment of skin wounds. The absence of infections or allergic reactions in subjects treated with AME underscores its potential as a safe therapeutic alternative. Additionally, the AME group exhibited lower instances of vascularization, edema, and fibrosis, highlighting its anti-inflammatory efficacy and potential effectiveness in wound healing. Based on these findings, while the efficacy of AMT in routine clinical use for wound healing is undeniable, AME also stands out for its ease of use. Completing preclinical studies within this thesis, AME holds potential as an alternative therapeutic product in this field. Phase studies are planned to clearly demonstrate its clinical effects.

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