Burn Centre, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
Scar Free Foundation Burn Research Centre, Birmingham, UK.
BMJ Open. 2023 Sep 25;13(9):e058006. doi: 10.1136/bmjopen-2021-058006.
Despite of recent advancement in the burns wound management, burn wound infection (BWI) is still one of the major cause of burns mortality. Patients who survive their burns injury still suffers from BWI related complication like delayed wound healing and poor scarring. BWI has been treated by application of topical antimicrobial agents or systemic antibiotics. Due to the global risk of developing systemic antibiotics resistance, medical research focuses on identifying single topical agent which has effective antimicrobial activity, easily available and cost effective. One such agent is acetic acid (AA). AA has been used as a topical antibacterial agent for the treatment of burns wounds for many years and has shown to have activity against gram-negative organisms including . So far there has been no consensus on optimal concentration that has effective antimicrobial activity, frequency of application, duration of treatment and most importantly good patient's tolerability. A randomised control study is required to answer all these questions.
To investigate the efficacy and tolerability of 0.5% and 2% of AA when applied to colonised burns wounds for 3 days after admittance to the Queen Elizabeth Hospital Birmingham.
This is a double-blinded, prospective, randomised, controlled, single-centre trial. Patients will be screened for eligibility in the inpatient area and those who are found to be eligible will be randomly assigned to one of two treatment groups: group 1: 0.5% AA (10 patients); group 2: 2% AA (10 patients); total number: 20 patients.
: Efficacy will be assessed by measuring the bacterial load from microbiology wound swabs for three consecutive days.: (1) The assessment of antimicrobial activity of AA and the minimum inhibitory concentrations. (2) Patient's tolerance by assessing Visual Analogue Scale pain score. (3) Time to 95% wound healing of treatment area. (4) Patient's perceived treatment allocation.
AceticA trial protocol was approved by the National Research Ethics Service (West Midlands-Edgbaston Research Ethics Committee; 17/WM/0407; IRAS 234132). This article refers to protocol version 5.0 dated 6 July 2020. The analysed results will be presented at national and international conferences related to management of burn patients. The generated articles based on the trial results will be submitted to peer review journals for publication.
ISRCTN11636684.
尽管烧伤创面管理近年来取得了进展，但烧伤创面感染（BWI）仍是烧伤患者死亡的主要原因之一。烧伤患者即使存活下来，仍会遭受 BWI 相关并发症的困扰，如创面愈合延迟和瘢痕形成不良。BWI 的治疗方法包括应用局部抗菌药物或全身抗生素。由于全球范围内对抗生素产生系统耐药性的风险，医学研究的重点是确定具有有效抗菌活性、易于获得且具有成本效益的单一局部药物。醋酸（AA）就是这样一种药物。AA 多年来一直被用作治疗烧伤创面的局部抗菌药物，并且已显示出对革兰氏阴性菌（包括 ）具有活性。到目前为止，尚无关于具有有效抗菌活性的最佳浓度、应用频率、治疗持续时间以及最重要的是患者良好耐受性的共识。需要进行随机对照研究来回答所有这些问题。
研究 0.5%和 2%的 AA 应用于伯明翰伊丽莎白女王医院收治烧伤患者的创面后 3 天的疗效和耐受性。
这是一项双盲、前瞻性、随机、对照、单中心试验。将在住院病房筛选患者的入选资格，符合入选标准的患者将随机分配到以下两个治疗组之一：第 1 组：0.5% AA（10 例）；第 2 组：2% AA（10 例）；总人数：20 例。
连续 3 天通过微生物学创面拭子测量细菌负荷来评估疗效：（1）AA 的抗菌活性和最小抑菌浓度的评估。（2）通过评估视觉模拟量表疼痛评分来评估患者的耐受性。（3）治疗区域达到 95%创面愈合的时间。（4）患者对治疗分配的感知。
醋酸 A 试验方案已获得国家伦理服务机构（西米德兰兹-埃德巴斯顿伦理委员会；17/WM/0407；IRAS 234132）批准。本文所指的是 2020 年 7 月 6 日第 5.0 版方案。分析结果将在与烧伤患者管理相关的国家和国际会议上公布。基于试验结果生成的文章将提交给同行评审期刊发表。
ISRCTN85030414。
