Bellingeri A, Falciani F, Traspedini P, Moscatelli A, Russo A, Tino G, Chiari P, Peghetti A
Wound Care Specialist Nurse, Head of Wound Care Department; I.r.c.c.s. Policlinico San Matteo, Pavia, Italy.
Wound Care Specialist Nurse, Coordinator Wound Care Department; Florence Hospital, Florence, Italy.
J Wound Care. 2016 Mar;25(3):160, 162-6, 168. doi: 10.12968/jowc.2016.25.3.160.
Research into surfactant solutions for the debridement of chronic wounds suggests that surfactants may support wound bed preparation (WBP) in chronic wounds, however their efficacy has not been evaluated in randomised controlled trials (RCTs). Our aim was to assess the clinical efficacy of a propylbetaine-polihexanide (PP) solution versus normal saline (NS) solution in WBP, assessing inflammatory signs and wound size reduction in patients with pressure ulcers (PUs) or vascular leg ulcers.
In a single-blinded randomised controlled trial (RCT) patients were randomly allocated to two groups and treated with either propylbetaine-polihexanide (PP) solution (Prontosan) or NS. Wounds were assessed using the Bates-Jensen wound assessment tool (BWAT). Assessments took place at inclusion (T0), day 7 (T1), day 14 (T2), day 21 (T3), and day 28 (T4). Outcomes were analysed using a two-tailed Student's t-test.
A total of 289 patients were included. Both groups had similar demographics, clinical status, and wound characteristics. Data analysis showed statistically significant differences between T0 and T4 for the following outcomes: BWAT total score, p=0.0248; BWAT score for inflammatory items, p=0.03; BWAT scores for wound size reduction (p=0.049) and granulation tissue improvement (p=0.043), all in favour of PP. The assessment of pain did not show any significant difference between the two groups.
The study results showed significantly higher efficacy of the PP solution versus NS solution, in reducing inflammatory signs and accelerating the healing of vascular leg ulcers and PUs. This evidence supports the update of protocols for the care of chronic wounds.
The authors have no conflict of interest regarding this research. This is an investigator initiated trial. B. Braun Milano SpA kindly provided the material under investigation for both treatment groups, and paid the Ethics Committees' application fees in all participating centres.
对用于慢性伤口清创的表面活性剂溶液的研究表明，表面活性剂可能有助于慢性伤口的创面准备（WBP），然而其疗效尚未在随机对照试验（RCT）中得到评估。我们的目的是评估丙基甜菜碱-聚己双胍（PP）溶液与生理盐水（NS）溶液在创面准备中的临床疗效，评估压疮（PU）或下肢血管性溃疡患者的炎症体征和伤口大小缩小情况。
在一项单盲随机对照试验（RCT）中，患者被随机分为两组，分别用丙基甜菜碱-聚己双胍（PP）溶液（普朗特桑）或生理盐水进行治疗。使用贝茨-詹森伤口评估工具（BWAT）对伤口进行评估。评估在纳入时（T0）、第7天（T1）、第14天（T2）、第21天（T3）和第28天（T4）进行。使用双尾学生t检验分析结果。
共纳入289例患者。两组在人口统计学、临床状况和伤口特征方面相似。数据分析显示，在以下结果方面，T0和T4之间存在统计学显著差异：BWAT总分，p = 0.0248；BWAT炎症项目评分，p = 0.03；BWAT伤口大小缩小评分（p = 0.049）和肉芽组织改善评分（p = 0.043），所有结果均有利于PP。疼痛评估显示两组之间无显著差异。
研究结果表明，PP溶液在减轻炎症体征以及加速下肢血管性溃疡和压疮愈合方面的疗效显著高于NS溶液。这一证据支持更新慢性伤口护理方案。
作者在本研究中不存在利益冲突。这是一项研究者发起的试验。B. Braun Milano SpA好心为两个治疗组提供了研究材料，并支付了所有参与中心伦理委员会的申请费用。
