家庭模式负压伤口治疗的安全性和效果评价

Safety and Efficacy of Home-based Negative Pressure Wound Therapy for Chronic Wounds

背景负压伤口治疗是全球公认的有效技术,国外广泛应用于医院、社区和家庭。国内主要在医院环境中实施,研究能否在家庭环境中安全、有效开展此技术,对提高我国慢性伤口患者的家庭治疗水平和效果有积极意义。目的评价家庭模式负压治疗处理慢性伤口的安全性与效果,为在家庭中开展此技术提供依据。方法2015年1月-2018年12月共纳入128例慢性伤口患者,非随机分为对照组62例和干预组66例,对照组在伤口护理门诊接受负压伤口治疗(门诊模式),干预组在家庭环境中接受负压伤口治疗(家庭模式),均连续治疗14 d,然后采用标准湿性疗法随访治疗3个月。安全性指标:负压治疗过程中观察伤口出血、皮肤浸渍、漏气报警、潮湿相关性皮肤损伤发生率。效果指标:观察负压治疗前和治疗后14 d细菌阳性率、面积缩小率、深度缩小率及随访治疗3个月的伤口治愈率、愈合时间。结果对照组脱落率为8.1%(5/62)、干预组脱落率为1.5%(1/66),差异无统计学意义(P>0.05)。对照组57例、干预组65例完成了3个月的负压治疗和随访,两组负压治疗时间接近[(17.5±7.6)d比(18.4±7.9)d,P>0.05]。两组皮肤浸渍、漏气报警次数及潮湿相关性皮肤损伤发生率比较,差异无统计学意义(P>0.05),两组均无一例发生伤口出血。干预组治疗14 d的面积缩小率[(49.4±22.1)%]高于对照组[(33.4±20.2)%],差异有统计学意义(P<0.05)。干预组和对照组的伤口治愈率比较[(81.5%(53/65)比54.4%(31/57)],差异有统计学意义(P<0.05),前者愈合时间短于后者[(51.7±16.9)d比(61.9±17.1)d],差异有统计学意义(P<0.05)。结论家庭模式负压伤口治疗能够安全、有效地用于各类慢性伤口,改善伤口治疗效果,可用于慢性伤口的家庭护理。

Background Negative pressure wound therapy(NPWT),a globally recognized effective technology,is widely used in hospitals,communities and home-based settings at abroad,but is mainly used in hospitals in China.Studying whether this technique can be carried out safely and effectively in home-based settings facilitates the improvement of level and effect home-based NPWT for chronic wound patients in China.Objective To evaluate the safety and efficacy of home-based NPWT for chronic wounds,providing a basis for the use of this technology in home-based settings.Methods This non-randomized control study was conducted among 128 patients with chronic wounds who were enrolled from January 2015 to December 2018.By patient subjective choice of care,they were divided into the control group(n=62)and the intervention group(n=66)treated with a 14-consecutive-day NPWT delivered in the wound care clinic,and delivered in home-based settings,respectively,then a 3-month follow-up treatment with standardized moist wound healing therapy.The safety was evaluated by adverse events occurred during treatment,including wound bleeding,skin immersion,air leakage alarm and moisture-associated skin damage(MASD),and outcome was evaluated by post-14-day treatment positive rate of bacteria,wound area,and rate of reduction in wound depth,and healing rate and healing time a the end of follow-up treatment.Results Altogether,57 receiving outpatient-based NPWT and 65 receiving home-based NPWT who completed the treatment were included in the finally analysis,after excluding 6 dropouts〔5(8.1%)in the control group and 1(1.5%)intervention group with no intergroup difference in dropout rate,P>0.05〕.There were no significant differences between the two groups in the frequency of skin immersion,air leakage alarm and the incidence of MASD(P>0.05).The intervention group and control group showed similar mean overall NPWT time〔(18.4±7.9)d vs(17.5±7.6)d〕(P>0.05).The rate of post-14-day-treatment wound area reduction in the intervention group was higher than that of the control group〔(49.4±22.1)%vs(33.4±20.2)%,P<0.05〕.No wound bleeding occurred during treatment.The wound healing rate of the intervention group and the control group were 81.5%(53/65)and 54.4%(31/57),respectively(P<0.05).The mean healing time of the former was shorter than that of the latter〔(51.7±16.9)d vs(61.9±17.1)d,P<0.05〕.Conclusion The home-based NPWT showed high safety and treatment effect in out study,which may be contributive to the wound outcome,and may be used for home care of chronic wounds.