Chiang Nathaniel, Rodda Odette A, Sleigh Jamie, Vasudevan Thodur
Department of Vascular Surgery, Waikato Hospital, Hamilton, New Zealand.
Department of Vascular Surgery, St. Vincent's Hospital, Melbourne, Victoria, Australia.
J Vasc Surg. 2017 Aug;66(2):564-571. doi: 10.1016/j.jvs.2017.02.050. Epub 2017 Jun 2.
Topical negative pressure (TNP) therapy is widely used in the treatment of acute wounds in vascular patients on the basis of proposed multifactorial benefits. However, numerous recent systematic reviews have concluded that there is inadequate evidence to support its benefits at a scientific level. This study evaluated the changes in wound volume, surface area, depth, collagen deposition, and tissue oxygenation when using TNP therapy compared with traditional dressings in patients with acute high-risk foot wounds.
This study was performed with hospitalized vascular patients. Forty-eight patients were selected with an acute lower extremity wound after surgical débridement or minor amputation that had an adequate blood supply without requiring further surgical revascularization and were deemed suitable for TNP therapy. The 22 patients who completed the study were randomly allocated to a treatment group receiving TNP or to a control group receiving regular topical dressings. Wound volume and wound oxygenation were analyzed using a modern stereophotographic wound measurement system and a hyperspectral transcutaneous oxygenation measurement system, respectively. Laboratory analysis was conducted on wound biopsy samples to determine hydroxyproline levels, a surrogate marker to collagen.
Differences in clinical or demographic characteristics or in the location of the foot wounds were not significant between the two groups. All patients, with the exception of two, had diabetes. The two patients who did not have diabetes had end-stage renal failure. There was no significance in the primary outcome of wound volume reduction between TNP and control patients on day 14 (44.2% and 20.9%, respectively; P = .15). Analyses of secondary outcomes showed a significant result of better healing rates in the TNP group by demonstrating a reduction in maximum wound depth at day 14 (36.0% TNP vs 17.6% control; P = .03). No significant findings were found for the other outcomes of changes in hydroxyproline levels (58.0% TNP vs 94.5% control; P = .32) or tissue perfusion by tissue oxyhemoglobin saturation (19.4% TNP vs 12.0% control; P = .07) at day 14. At 1 year of follow-up, there were no significant outcomes in the analysis of wound failure, major amputation, and overall survival rates between the two groups.
In this pilot study, applying TNP to acute high-risk foot wounds in patients with diabetes or end-stage renal failure improved the wound healing rate in reference to wound depth. This suggests that TNP may play a role in enhancing wound healing. This study sets the foundation for larger studies to evaluate the superiority of TNP over traditional dressings in high-risk foot wounds.
基于提出的多方面益处，局部负压（TNP）疗法广泛应用于血管疾病患者急性伤口的治疗。然而，近期众多系统评价得出结论，在科学层面上，尚无充分证据支持其益处。本研究评估了在急性高危足部伤口患者中，与传统敷料相比，使用TNP疗法时伤口体积、表面积、深度、胶原蛋白沉积及组织氧合的变化。
本研究针对住院血管疾病患者开展。选取48例患者，这些患者在接受手术清创或小截肢术后出现急性下肢伤口，血供充足，无需进一步手术血管重建，且被认为适合TNP疗法。完成研究的22例患者被随机分为接受TNP的治疗组或接受常规局部敷料的对照组。分别使用现代立体摄影伤口测量系统和高光谱经皮氧合测量系统分析伤口体积和伤口氧合情况。对伤口活检样本进行实验室分析以测定羟脯氨酸水平，其为胶原蛋白的替代标志物。
两组在临床或人口统计学特征或足部伤口位置方面差异无统计学意义。除2例患者外，所有患者均患有糖尿病。这2例无糖尿病的患者患有终末期肾衰竭。在第14天，TNP组和对照组患者伤口体积减小的主要结局无显著差异（分别为44.2%和20.9%；P = 0.15）。次要结局分析显示，TNP组愈合率更高，在第14天最大伤口深度减小（TNP组为36.0%，对照组为17.6%；P = 0.03）。在第14天，羟脯氨酸水平变化（TNP组为58.0%，对照组为94.5%；P = 0.32）或组织氧合血红蛋白饱和度的组织灌注（TNP组为19.4%，对照组为12.0%；P = 0.07）的其他结局未发现显著结果。在1年随访期，两组在伤口失败、大截肢和总生存率分析中无显著结局。
在这项初步研究中，对糖尿病或终末期肾衰竭患者的急性高危足部伤口应用TNP，在伤口深度方面提高了伤口愈合率。这表明TNP可能在促进伤口愈合中发挥作用。本研究为更大规模研究奠定了基础，以评估TNP在高危足部伤口中优于传统敷料的优势。
