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在所有疾病控制与预防中心伤口分类的中心进行的关于抗菌涂层、非交联、脱细胞猪真皮基质(XenMatrix™ AB外科移植物)用于疝修补的前瞻性多中心研究:24个月随访队列。

Prospective, multicenter study of antimicrobial-coated, noncrosslinked, acellular porcine dermal matrix (XenMatrix™ AB Surgical Graft) for hernia repair in all centers for disease control and prevention wound classes: 24-month follow-up cohort.

作者信息

Ilahi Obeid N, Velmahos George, Janis Jeffrey E, Kovach Stephen J, McLean Susan F, Askari Reza, Sommer Courtney A, Agarwal Suresh, Srinivasan Jahnavi, Wong Alex K, Pakula Andrea, Miranda Edward P, Breen Kerry, Shapiro Mark, Deeken Corey R, Stringer R Cody, McGraw J Reed, Bascone Corey, Martindale Robert G

机构信息

Washington University School of Medicine.

Massachusetts General Hospital.

出版信息

Ann Med Surg (Lond). 2023 Apr 19;85(5):1571-1577. doi: 10.1097/MS9.0000000000000695. eCollection 2023 May.

Abstract

UNLABELLED

Prospective, multicenter, single-arm study of antimicrobial-coated, noncrosslinked, acellular porcine dermal matrix (AC-PDM) in a cohort involving all centers for disease control and prevention wound classes in ventral/incisional midline hernia repair (VIHR).

MATERIALS AND METHODS

Seventy-five patients (mean age 58.6±12.7 years; BMI 31.3±4.9 kg/m) underwent ventral/incisional midline hernia repair with AC-PDM. Surgical site occurrence (SSO) was assessed in the first 45 days post-implantation. Length of stay, return to work, hernia recurrence, reoperation, quality of life, and SSO were assessed at 1, 3, 6, 12, 18, and 24 months.

RESULTS

14.7% of patients experienced SSO requiring intervention within 45 days post-implantation, and 20.0% thereafter (>45 d post-implantation). Recurrence (5.8%), definitely device-related adverse events (4.0%), and reoperation (10.7%) were low at 24 months; all quality-of-life indicators were significantly improved compared to baseline.

CONCLUSION

AC-PDM exhibited favourable results, including infrequent hernia recurrence and definitely device-related adverse events, with reoperation and SSO comparable to other studies, and significantly improved quality of life.

摘要

未标注

一项前瞻性、多中心、单臂研究,在涉及所有疾病控制与预防中心伤口分类的队列中,对抗菌涂层、非交联、无细胞猪真皮基质(AC-PDM)用于腹侧/切口中线疝修补术(VIHR)进行研究。

材料与方法

75例患者(平均年龄58.6±12.7岁;体重指数31.3±4.9kg/m²)接受了使用AC-PDM的腹侧/切口中线疝修补术。在植入后的前45天评估手术部位感染(SSO)情况。在1、3、6、12、18和24个月时评估住院时间、恢复工作情况、疝复发、再次手术、生活质量和SSO。

结果

14.7%的患者在植入后45天内出现需要干预的SSO,此后(植入后>45天)为20.0%。24个月时复发率(5.8%)、明确与器械相关的不良事件发生率(4.0%)和再次手术率(10.7%)较低;与基线相比,所有生活质量指标均有显著改善。

结论

AC-PDM显示出良好的结果,包括疝复发率低和明确与器械相关的不良事件发生率低,再次手术和SSO与其他研究相当,且生活质量有显著改善。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8fb6/10205341/5c71ddacb679/ms9-85-1571-g001.jpg

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