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一种新型清创设备治疗难愈性创面:前瞻性研究。

A novel debridement device for the treatment of hard-to-heal wounds: a prospective trial.

机构信息

The SerenaGroup Research Foundation, Cambridge, MA, US.

出版信息

J Wound Care. 2021 May 1;30(Sup5):S32-S36. doi: 10.12968/jowc.2021.30.Sup5.S32.

DOI:10.12968/jowc.2021.30.Sup5.S32
PMID:33979231
Abstract

OBJECTIVE

Debridement, the removal of nonviable tissue, forms the foundation of wound care practice. Clinicians have a variety of debridement methods at their disposal: sharp, biologic, enzymatic, autolytic and mechanical. The choice of debridement technique depends on the patient care setting, ulcer type and the clinician's experience, training, comfort level and licensure. This prospective study evaluated a novel debridement instrument, EZ-Debride (MDM Ventures, US). Cutting flutes on the head of the tool permit uniform removal of dead tissue while lessening the risk of deeper injury. It may also minimise pain during the debridement procedure.

METHOD

Subjects with hard-to-heal wounds, drawn from a single wound care centre, participated in this institutional review board-approved prospective clinical study. Pain was measured before, during and after debridement using a numerical scale. Assessment of bacterial burden using fluorescence imaging (MolecuLight, Canada) was performed before and after debridement.

RESULTS

Enrolment of 10 male and 12 female subjects, with a total of 28 wounds, was carried out over a two-month period by two investigators at a single institution. The average age of subjects was 64 years (range: 22-95 years). The average wound duration was 29 weeks (range: 6-142 weeks). Wound types included diabetic foot, venous leg and pressure ulcers, post-surgical and traumatic wounds. The average pain score at the time of enrolment was 3.9. Subjects reported an average increase in pain with debridement of 0.6 points (range: 0-8). Fluorescence imaging demonstrated a reduction in bacterial load in 69% of cases, with complete resolution in 19% of wounds. Haemostasis was achieved with direct pressure in all cases and the only adverse event was a wound infection that occurred four days after debridement.

CONCLUSION

The results suggest that this novel debridement tool can safely remove nonviable tissue with minimal discomfort and reduce bacterial burden similar to results achieved by sharp debridement.

摘要

目的

清创术,即清除失活组织,是伤口护理实践的基础。临床医生有多种清创方法可供选择:锐性、生物、酶、自溶和机械。清创技术的选择取决于患者的护理环境、溃疡类型以及临床医生的经验、培训、舒适度和执照。本前瞻性研究评估了一种新型清创工具,EZ-Debride(MDM Ventures,美国)。工具头部的切割槽允许均匀地去除坏死组织,同时降低更深层损伤的风险。它还可能减轻清创过程中的疼痛。

方法

从单个伤口护理中心招募患有难以愈合的伤口的受试者参加这项经机构审查委员会批准的前瞻性临床研究。使用数字量表在清创前、清创中和清创后测量疼痛。使用荧光成像(加拿大 MolecuLight)评估清创前后的细菌负荷。

结果

在两个月的时间里,两名研究人员在一家机构招募了 10 名男性和 12 名女性受试者,共有 28 个伤口。受试者的平均年龄为 64 岁(范围:22-95 岁)。平均伤口持续时间为 29 周(范围:6-142 周)。伤口类型包括糖尿病足、静脉腿部和压力性溃疡、术后和创伤性伤口。入组时的平均疼痛评分为 3.9。受试者报告说,清创时疼痛平均增加 0.6 分(范围:0-8)。荧光成像显示 69%的情况下细菌负荷减少,19%的伤口完全缓解。所有情况下均通过直接按压止血,唯一的不良事件是清创后四天发生的伤口感染。

结论

结果表明,这种新型清创工具可以安全地去除失活组织,且患者不适感最小,并可降低细菌负荷,与锐性清创的效果相似。

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