Volume 44 Number 3

WHAM evidence summary: potassium permanganate (Condy’s crystals)

Emily Haesler

Keywords Traditional wound management, evidence summary, Condy’s crystals, potassium permanganate

For referencing Haesler E. WHAM evidence summary: potassium permanganate (Condy’s crystals). WCET® Journal 2024;44(3):26-30.

DOI 10.33235/wcet.44.3.26-30

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Author(s)

References

中文

Clinical question

What is the best available evidence for potassium permanganate for treating wounds?

Summary

Potassium permanganate (also known as Condy’s crystals) is an antiseptic solution with astringent properties that are leveraged to reduce exudate.1 The solution is used to manage skin conditions and a range of wounds including diabetic foot ulcers (DFUs), venous leg ulcers (VLUs), traumatic wounds and wound-related cellulitis. However, the evidence for the efficacy of potassium permanganate to treat wounds is very limited, primarily coming from low level evidence and studies at high risk of bias. Level 1 evidence2, 3 showed reduction in wound size for DFUs associated with using a commercially prepared 5% potassium permanganate solution, but the research was at moderate-to-high risk of bias. Research on potassium permanganate crystals/tablets prepared at a very dilute concentration was primarily Level 4 evidence4-9 at high risk of bias and did not provide sufficient evidence of its efficacy. Use of potassium permanganate for treating wounds should be evaluated with consideration to the risk of adverse events and to the other antimicrobial solutions that are available in the clinical and geographic context.

Clinical practice recommendations

All recommendations should be applied with consideration to the wound, the person, the health professional and the clinical context.
 

There is insufficient evidence to make a recommendation on the use of potassium permanganate to promote wound healing.

 

Sources of evidence: search and appraisal

 

This summary was conducted using methods published by the Joanna Briggs Institute.10-13 The summary is based on a systematic literature search combining search terms related to potassium permanganate, and wound care. Searches were conducted for evidence reporting use of potassium permanganate for treating human wounds published from 01 January 1980 up to 31 May 2024 in English in the following databases: Cumulative Index to Nursing and Allied Health Literature (CINAHL), Medline (Ovid), Google Scholar, Embase (Ovid), AMED, Health Internetwork Access to Research Initiative (Hinari, access via Research4Life) and Cochrane Library. Levels of evidence for intervention studies are in Table 1.

 

Table 1: Levels of evidence for clinical studies

wham crystals table 1.png

 

Background

Potassium permanganate (also known as Condy’s crystals) is an early antiseptic solution dating to the 1850s.1 It has been used in skin and wound care for its antimicrobial qualities and astringent properties that reduce exudate.1, 2, 6, 21, 22, 24 However, the antimicrobial efficacy of potassium permanganate has been questioned in the literature, and it is reported to be low and short-lived,20, 22, 23, 25 with some bench research demonstrating no significant effect in reducing bacteria after application of 0.015% concentration solution for 15 minutes.26

Clinical evidence on potassium permanganate for treating wounds

Studies reporting clinical outcomes for potassium permanganate used in wound management are summarised in Table 2. The research included evidence on a 5% potassium permanganate solution commercially available in some countries, and on potassium permanganate tablets or crystals dissolved in water to a very dilute solution. The best available clinical evidence includes the studies below.

5% potassium permanganate commercial solution

  • A small (n = 25) single-blinded RCT2 at high risk of bias explored 5% potassium permanganate (n = 15, treatment group) for treating Wagner stage I or II DFUs compared with standard treatment that included topical super oxidised solution (MicrodacynTM; n = 10, control group). Wounds in both groups were cleansed daily with potable water and an antiseptic treatment (type not reported) and then either potassium permanganate or super oxidised solution was applied to the entire wound surface area. No rinsing was conducted after application, but excess solution was removed with gauze from deeper wounds. Wound dressings were not reported. Wounds were assessed weekly and debrided if required. At baseline, significantly more DFUs in the treatment group had signs of local infection (64% versus 20%, p = 0.03). Wound surface area was measured weekly using acetate tracings and a digital area calculator. After 3 weeks, the treatment group showed a 78% reduction in wound surface area, which was statistically significantly greater than the 38% surface area reduction observed in the control group (p < 0.009). Four DFUs in the treatment group completely healed by 21 days compared to none in the control group. The number needed to treat (NNT) with potassium permanganate to achieve 50% or greater reduction in DFU size at 21 days was 2.18 (95% confidence interval [CI]: 1.26 to 8.25)2 (Level 1).
  • A second small (n =30 randomised, n = 23 analysed) non-blinded RCT3 at moderate risk of bias reported use of 5% potassium permanganate for Wagner stage I or II DFUs. In this study, participants attended their own wound care daily in a home setting. The treatment group participants (n = 12) washed the DFU with soap and water and applied the potassium permanganate solution topically to the ulcer while avoiding healthy skin (method of application and wound dressing not reported). The control group participants (n = 11) used soap and water, topical and systemic antibiotics (types not reported) and no wound dressing. There was a statistically significant (p = 0.005) reduction in the number of DFUs exhibiting signs of local wound infection in the treatment group versus the control group within the first 7 days of treatment, and no DFUs in either group were clinically infected after 21 days. The treatment group ulcers were statistically significantly smaller in length than the control group at baseline (p = 0.012), 7 days (p = 0.02), 14 days (p = 0.024) and 21 days (p = 0.006). Four DFUs in the treatment group completely healed by 21 days compared to none in the control group3 (Level 1).
  • A non-randomised comparative study14 (n = 40) at moderate risk of bias explored potassium permanganate soaks for managing cellulitis associated with grazes, cuts, skin conditions, trauma and ulcers. The treatment group (n = 20) received twice daily, 15–minute 5% potassium permanganate solution-soaked wraps for 7 days and the control group (n = 20) received non-defined daily standard care. Outcomes were measured using a cellulitis observational checklist that was developed and tested for the study and reported to have high content validity and inter- and intra-reliability. The checklist included percent of erythema, pain severity, swelling and local temperature. Statistically significant (p < 0.05) improvements were shown between baseline and one week for intervention group versus control group for all outcomes on the checklist14 (Level 2).

Potassium permanganate crystals/tablets

  • A non-randomised comparative study15 (n = 30) at high risk of bias explored potassium permanganate skin soaks for managing cellulitis. Participants had at least two anatomical areas affected by cellulitis and acted as their own controls. One anatomical location received twice daily 15–minute potassium permanganate-soaked wraps and the second anatomical location received twice daily 15–minute super-oxidised solution (type not reported) soaked wraps. Outcomes were measured after 7 days and included extent of reduction of erythema and other clinical signs of cellulitis. Reduction in erythema was greater in the control group versus the treatment group after 7 days (72.10% reduction versus 59.05% reduction, p = 0.045). There were no statistically significant differences between groups for other measures, including total cellulitis severity score15 (Level 2).
  • A case series (n = 48) at high risk of bias described the use of potassium permanganate (1:5,000) for continuous irrigation of significant, open trauma injuries in the context of gas gangrene. In these cases, effectiveness of the treatment was not clearly reported4 (Level 4).
  • Several case reports at high risk of bias are also available. The reports provide minimal detail about the use of potassium permanganate, but universally report positive wound outcomes. In many of the reports, multiple different treatments were used for a duration before introducing potassium permanganate to the regimen or were used concurrently. This made it difficult to evaluate the role the potassium permanganate solution may have played in achieving healing. The case reports include use of potassium permanganate to treat:
    • upper limb necrotic ulcers arising from pyoderma gangrenosum in a person with diabetes mellitus, used in combination with topical silver sulfadiazine and systemic antibiotics to achieve complete healing after 4–6 weeks5.
    • traumatic, necrotic ulcers of dermal thickness, used in combination with aloe vera gel to reduce wound exudate6.
    • VLUs and venous eczema in a critically ill person with Cushing’s syndrome, used in combination with Prontosan® gel and solution, antibiotics and topical corticosteroids and graduated compression bandaging to achieve eventual healing7.
    • a sloughy VLU and venous eczema in a person with early lymphoedema, used in combination with corticosteroids, an antimicrobial dressing8, and compression therapy of various sorts over different time periods to achieve eventual healing.
    • severe ulceration from contact with a Paederus sp. insect that failed to respond to corticosteroid treatment, to achieve reduction in wound breakdown within 48 hours9.

 

Table 2. Summary of the primary evidence for potassium permanganate for wound management

wham crystals table 2.png

 

Considerations for use

Wound clinicians should consider local policies, procedures, and licensing before implementing wound treatments.

Preparation and clinical use

  • In clinical use, skin and wounds are soaked in potassium permanganate for up to 20 minutes.
  • Potassium permanganate can be prepared by using crystals or tablets dissolved in lukewarm water to a very dilute solution (e.g. 1:10,000021, 22). When available, one 400mg tablet is dissolved in four litres of water.1, 21 If crystals are used, the resulting solution should be a very pale pink.
  • Commercially available 5% solution potassium permanganate is available in some geographic locations.
  • When practical, the wound is soaked in a bucket/basin of diluted potassium permanganate solution for 10–15 minutes1, 7, 22. When this is not possible, gauze can be soaked in the solution and applied to the wound, with re-soaking of the gauze every 3–4 minutes to maintain the wetness for 10–15 minutes1.

Adverse events

  • Care is required with dilution because the solution is corrosive and can cause burns if prepared and applied inappropriately.1,19
  • A risk of toxicity when used on large areas of skin is reported.2, 21, 22 Caution is recommended for people with heart or renal comorbidities due to this risk.21.
  • Skin irritation and pain on application has been reported2, 3, 21-23. In one study included in this summary, one participant withdrew due to intolerable pain on application of potassium permanganate to a DFU.2
  • Several cases of severe gastric ulceration arising from accidental ingestion are reported in the literature16-18. In these cases, people mistook tablets or crystals for other medications. People storing potassium permanganate at home should receive education on this risk17.
  • Potassium permanganate is a dye that could stain the skin and nails brown1, 22; this can be somewhat minimised by reducing the soaking duration and protecting nails with paraffin or varnish21.

Conflicts of interest

The author declares no conflicts of interest in accordance with International Committee of Medical Journal Editors (ICMJE) standards.

Funding

The author received no funding for this study.

About WHAM evidence summaries

WHAM evidence summaries provide a summary of the best available evidence on specific topics and make suggestions that can be used to inform clinical practice. Evidence contained within this summary should be evaluated by appropriately trained professionals with expertise in wound prevention and management, and the evidence should be considered in the context of the individual, the professional, the clinical setting and other relevant clinical information.

WHAM evidence summaries are developed using methodology consistent with that published by Joanna Briggs Institute10-13. Evidence underpinning a WHAM recommendation is identified via a PICO search strategy, assigned a level of evidence and evaluated for risk of bias. All WHAM evidence summaries are peer-reviewed by an international Expert Reference Group. For more information on the methods and the WHAM Expert Reference Group, visit the website: www.WHAMwounds.com.

Copyright © Wound Healing and Management Collaborative, Curtin University, and the authors.


WHAM证据总结:高锰酸钾(康迪晶体)

Emily Haesler

DOI: 10.33235/wcet.44.3.26-30

Author(s)

References

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临床问题

高锰酸钾用于治疗伤口的现有最佳证据有哪些?

概述

高锰酸钾(又称康迪晶体)是一种具有收敛特性的抗菌溶液,可用于减少渗出物。1该溶液可用于治疗皮肤病和各种伤口,包括糖尿病足溃疡(DFU)、下肢静脉性溃疡(VLU)、创伤性伤口及伤口相关蜂窝组织炎。然而,关于高锰酸钾治疗伤口的有效性证据非常有限,主要来自低级别证据和高偏倚风险的研究。1级证据2, 3显示,使用市售的5%高锰酸钾溶液可减少DFU的伤口面积,但该研究存在中度至高度的偏倚风险。关于以极稀释浓度制备的高锰酸钾晶体/片剂的研究主要是4级证据4-9,具有高偏倚风险,并且没有提供足够的证据证明其有效性。在评价使用高锰酸钾治疗伤口时,应考虑不良事件的风险以及临床和地理环境中可用的其他抗菌溶液。

临床实践建议

采用任何建议时,应考虑伤口、患者、专业医护人员和临床环境。

 

关于使用高锰酸钾促进伤口愈合的建议,目前尚无足够的证据。

 

证据来源检索和评价

本总结采用乔安娜 布里格斯研究所公布的方法进行10-13。本总结基于系统性文献检索,结合了与高锰酸钾、伤口护理相关的检索词。在以下数据库中检索了1980年1月1日至2024年5月31日期间以英文发表的报告使用高锰酸钾治疗人体伤口的证据:护理与联合卫生文献累积索引(CINAHL)、Medline(Ovid)、谷歌学术、Embase(Ovid)、AMED、健康网络研究计划(Health 卫生互联网共享研究成果倡议(Hinari,通过Research4Life访问)和Cochrane图书馆。表1报告了干预研究的证据等级。

 

表1:临床研究的证据等级

wham 1 table 1 - cn.png

 

背景

高锰酸钾(又称康迪晶体)是一种可追溯到19世纪50年代的早期抗菌溶液。1它具有抗菌性和收敛性,可减少渗出物,因此被用于皮肤和伤口护理。1, 2, 6, 21, 22, 24然而,高锰酸钾的抗菌效果在文献中受到质疑,据报道其功效低且持续时间短,20, 22, 23, 25一些实验室研究表明,在应用0.015%浓度的高锰酸钾溶液15分钟后,减少细菌的效果并不明显。26

高锰酸钾治疗伤口的临床证据

表2总结了报告高锰酸钾用于伤口管理的临床结果的研究。研究包括一些国家市售的5%高锰酸钾溶液证据,以及高锰酸钾片剂或晶体溶于水后形成的稀释溶液证据。现有的最佳临床证据包括以下研究。

市售5%高锰酸钾溶液

  • 一项具有高偏倚风险的小型(n=25)单盲随机对照试验(RCT)2探索了5%高锰酸钾(n=15,治疗组)治疗Wagner I期或II期DFU的效果,并与包含局部超氧化溶液的标准治疗(MicrodacynTM;n=10,对照组)进行了比较。每天用饮用水和消毒剂(类型未报告)对两组患者的伤口进行清洁,然后在整个伤口表面区域涂抹高锰酸钾或超氧溶液。涂抹后无需冲洗,但可以使用纱布清除伤口深处多余的溶液。未报告伤口敷料。每周对伤口进行评估,必要时进行清创。基线时,治疗组中有局部感染迹象的DFU明显更多(64% vs. 20%,p=0.03)。每周使用醋酸纤维素薄膜描图和数字面积计算器测量伤口表面积。3周后,治疗组的伤口表面积减少了78%,这在统计学上显著高于对照组观察到的38%的表面积减少(p<0.009)。治疗组中有四例DFU在21天内完全愈合,对照组则无一例愈合。使用高锰酸钾治疗21天使DFU面积缩小50%或更大所需的治疗人数(NNT)为2.18(95%置信区间[CI]:1.26-8.25)2(1级)。
  • 第二项具有中等偏倚风险的小型(随机样本数=30,分析样本数=23)RCT3报告了使用5%的高锰酸钾治疗Wagner I期或II期DFU。在该研究中,受试者每日于家中自行进行伤口护理。治疗组受试者(n=12)用肥皂和水清洁DFU,然后将高锰酸钾溶液局部涂抹在溃疡处,同时避开健康皮肤(涂抹方法与伤口敷料均未报告)。对照组受试者(n=11)使用肥皂和水、局部和全身抗生素(类型未报告),但未使用伤口敷料。在治疗的前7天内,治疗组与对照组相比,出现局部伤口感染迹象的DFU数量在统计学上显著减少(p=0.005),21天后,两组均未出现临床感染的DFU。治疗组溃疡的长度在基线(p=0.012)、7天(p=0.02)、14天(p=0.024)和21天(p=0.006)时均显著小于对照组。治疗组中有四例DFU在21天内完全愈合,对照组则无一例愈合3(1级)。
  • 一项具有中等偏倚风险的非随机比较研究14(n=40)探讨了高锰酸钾浸泡治疗与擦伤、割伤、皮肤病、创伤和溃疡相关蜂窝组织炎的效果。治疗组(n=20)接受每日两次、每次15分钟的5%高锰酸钾溶液浸泡湿敷,持续7天,对照组(n=20)接受无规定的日常标准护理。使用专为研究开发和测试的蜂窝组织炎观察检查表来衡量结局,该检查表具有较高的内容效度和内部、外部信度。检查表涵盖了红斑百分比、疼痛严重程度、肿胀和局部温度。与对照组相比,干预组在检查表上的所有结局在基线和一周之间均显示出统计学显著改善(p<0.05)14(2级)。

 

2.高锰酸钾用于伤口管理的主要证据总结

wham 1 table 2 - cn.png

 

高锰酸钾晶体/片剂

  • 一项具有高偏倚风险的非随机比较研究15(n=30)探讨了高锰酸钾皮肤浸泡治疗蜂窝组织炎的效果。受试者至少有两个解剖部位受到蜂窝组织炎的影响,并作为自身对照。一个解剖部位接受每日两次、每次15分钟的高锰酸钾溶液浸泡湿敷,第二个解剖部位接受每日两次、每次15分钟超氧化溶液(类型未报告)浸泡包裹治疗。7天后测量结局,包括红斑消退程度和蜂窝组织炎的其他临床症状。7天后,对照组的红斑消退程度高于治疗组(减少72.10% vs. 减少59.05%,p=0.045)。在蜂窝组织炎严重程度总分等其他指标上,组间差异无统计学意义15(2级)。
  • 一项具有高偏倚风险的病例系列研究(n=48)描述了在气性坏疽的情况下使用高锰酸钾(1:5,000)持续冲洗重大开放性创伤的情况。在这些案例中,未明确报告治疗效果4(4级)。
  • 还有数份具有高偏倚风险的病例报告。这些报告对于高锰酸钾的使用提供的细节甚少,但普遍报告了积极的伤口治疗结局。在许多报告中,在将高锰酸钾引入治疗方案之前,曾在一段时间内使用过多种不同的治疗方法,或同时使用多种治疗方法。因此,很难评估高锰酸钾溶液在促进愈合方面可能发挥的作用。病例报告包括使用高锰酸钾进行治疗:
    • 糖尿病患者坏疽性脓皮病引起的上肢坏死性溃疡,与局部用磺胺嘧啶银和全身抗生素联合使用,4-6周后完全愈合5
    • 真皮厚度的创伤性、坏死性溃疡,与芦荟胶结合使用可减少伤口渗出物6
    • Cushing综合征危重患者的VLU和静脉湿疹,与Prontosan®凝胶和溶液、抗生素和局部皮质类固醇以及分级压迫包扎联合使用,以实现最终愈合7
    • 早期淋巴水肿患者的粘液性VLU和静脉湿疹,与皮质类固醇、抗菌敷料8和不同时间段的各种压迫疗法联合使用,以实现最终愈合。
    • 因接触毒隐翅虫而出现严重溃疡,经皮质类固醇治疗无效,48小时内伤口破裂程度减轻9

使用注意事项

伤口临床医生在实施伤口治疗之前,应考虑当地政策、程序和许可情况。

制备和临床使用

  • 在临床使用中,皮肤和伤口在高锰酸钾中浸泡长达20分钟。
  • 高锰酸钾可以通过使用溶解在温水中的晶体或片剂制成极稀的溶液(例如1:10,000021, 22)来制备。如果有现成的片剂,可以在4 L水中溶解一片
  • 400 mg片剂。1, 21如果使用晶体,所得溶液应为淡粉色。
  • 在某些地区可以买到市售的5%高锰酸钾溶液。
  • 在可行的情况下,将伤口浸泡在一桶/盆经稀释的高锰酸钾溶液中10-15分钟1, 7, 22。如果无法做到这一点,可将纱布浸泡在溶液中,然后敷在伤口上,每隔3-4分钟重新浸泡纱布一次,以保持湿润10-15分钟1

不良事件

  • 稀释时需要小心,因为溶液具有腐蚀性,如果制备和使用不当,可能会造成灼伤。1,19
  • 据报道,大面积皮肤使用时有中毒风险。2, 21, 22由于存在这种风险,建议患有心脏病或肾病的患者慎用21
  • 据报道,涂抹时会造成皮肤刺激和疼痛2, 3, 21-23。在本总结中的一项研究中,一例受试者因无法忍受高锰酸钾涂抹在DFU上的疼痛而退出研究。2
  • 文献中报道了数例因意外摄入而导致严重胃溃疡的病例16-18。在这些案例中,人们误将片剂或晶体当作其他药物。家中储存高锰酸钾的相关人员应接受有关这一风险的教育17
  • 高锰酸钾是一种染料,可以将皮肤和指甲染成棕色1, 22;但通过缩短浸泡时间和用石蜡或清漆保护指甲,可在一定程度上减少这种情况的发生21

利益冲突

根据国际医学期刊编辑委员会(ICMJE)的标准,作者声明无利益冲突。

资助

作者未因该项研究收到任何资助。

关于WHAM证据总结

WHAM证据总结提供了关于特定主题的最佳可用证据的总结,并提出了可用于指导临床实践的建议。本总结中包含的证据应由经过适当培训的具有伤口预防和管理专业知识的专业人士进行评价,并应根据个人、专业人士、临床环境以及其他相关临床信息考虑证据。

WHAM证据总结的编制方法与乔安娜·布里格斯研究所公布的方法一致10-13。通过PICO检索策略识别支持WHAM建议的证据,划分证据等级并评价偏倚风险。所有WHAM证据总结由国际专家参考小组进行同行评审。欲了解更多有关该方法和WHAM专家参考小组的信息,请访问网站:www.WHAMwounds.com

版权所有˝ 科廷大学伤口愈合和管理协作组织以及相关作者。


Author(s)

Emily Haesler
PhD P Grad Dip Adv Nurs (Gerontics) BN FWA
Adjunct Professor, Curtin University, Curtin Health Innovation Research Institute,
Wound Healing and Management (WHAM) Collaborative

References

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