Schulz Alexandra, Shoham Yaron, Rosenberg Lior, Rothermund Irene, Perbix Walther, Christian Fuchs Paul, Lipensky Alexandra, Schiefer Jennifer Lynn
From the *Department of Plastic Surgery, Hand Surgery, Burn Center, Cologne-Merheim Medical Center (CMMC), University of Witten/Herdecke, Cologne, Germany; and †Department of Plastic and Reconstructive Surgery, Soroka University Medical Center, Faculty of Health Sciences, Ben Gurion University of the Negev, Be'er-Sheva, Israel.
J Burn Care Res. 2017 Jul/Aug;38(4):e745-e755. doi: 10.1097/BCR.0000000000000478.
Severe burns of the hands are extremely challenging, given their anatomic complexity and vulnerability. Although excisional debridement with autografting remains the standard of care (SOC), previous studies have shown that use of enzymatic debridement with bromelain (NexoBrid, EDNX) enables rapid, selective enzymatic debridement, preserving viable tissue. To date, only two studies accruing data on EDNX in this setting have been published. The current study was conducted to compare EDNX with traditional surgical debridement (TSD) of deep dermal and full-thickness hand burns. This single-center, controlled clinical trial included 40 patients, aged 18 to 76 years, with deep dermal burns of the hand. The first 20 patients were debrided surgically, and the other 20 patients were using EDNX for debridement. Therapeutic selectivity, time to complete debridement and healing, complications, and 3-month functional/esthetic outcomes were compared by group. EDNX (vs TSD) significantly reduced time to complete debridement after admission (0.95 day vs 7.750 days; P < .001) and treatments needed for complete debridement (1.05 vs 1.45; P < .001), improving burn depth evaluation (initially overestimated in 55% of EDNX-treated patients). The number of wounds requiring autografting was certainly reduced (15% vs 95%; P = .034), as was time to complete healing after first debridement (23.30 vs 32.00 days; P < .001), and early scar quality after 3 months was nearly equivalent, with only heightened local redness in the EDNX group (P < .001). Compared with TSD, EDNX was superior in burn depth evaluation, tissue preservation, completeness of debridement, and wound closure. Scar quality after 3 months did not differ substantially.
手部严重烧伤极具挑战性,因其解剖结构复杂且脆弱。尽管自体移植切除清创术仍是标准治疗方法(SOC),但先前研究表明,使用菠萝蛋白酶进行酶解清创术(NexoBrid,EDNX)可实现快速、选择性酶解清创,保留存活组织。迄今为止,仅有两项关于EDNX在此情况下的数据积累研究已发表。本研究旨在比较EDNX与传统手术清创术(TSD)治疗手部深度真皮和全层烧伤的效果。这项单中心对照临床试验纳入了40例年龄在18至76岁之间的手部深度真皮烧伤患者。前20例患者接受手术清创,另外20例患者使用EDNX进行清创。按组比较治疗选择性、完成清创和愈合的时间、并发症以及3个月时的功能/美学结果。EDNX(与TSD相比)显著缩短了入院后完成清创的时间(0.95天对7.750天;P <.001)以及完成清创所需的治疗次数(1.05对1.45;P <.001),改善了烧伤深度评估(在55%接受EDNX治疗的患者中最初被高估)。需要自体移植的伤口数量确实减少了(15%对95%;P =.034),首次清创后完成愈合的时间也减少了(23.30天对32.00天;P <.001),3个月后的早期瘢痕质量几乎相当,只是EDNX组局部发红更明显(P <.001)。与TSD相比,EDNX在烧伤深度评估、组织保留、清创完整性和伤口闭合方面更具优势。3个月后的瘢痕质量没有显著差异。