Abstract：
BACKGROUND: Negative-pressure-wound-therapy (NPWT) has become a widely used tool for the coverage and active treatment of complex wounds, including burns. This study aimed to evaluate the effectiveness of NPWT in acute burns of upper and lower extremities and to compare results to the standard-of-care (SOC) at our institution.
METHODS: Patients that were admitted to our institution between May 2019 and November 2021 with burns on extremities between 0.5 % and 10 % of the total body surface area (%TBSA) were included and randomized to either NPWT or SOC (polyhexanide gel, fatty gauze, and cotton wool). Treatment was performed until complete wound healing. Patients that required skin grafts, received additional NPWT after grafting independent on the initial group allocation.
RESULTS: Sixty-five patients suffering from burn injury between May 2019 and November 2021 were randomized into treatment with NPWT (n = 33) or SOC (n = 32); of these, 33 patients (NPWT) and 28 patients (SOC) had complete data sets and were included in the analysis. Both groups were similar regarding age (39.8 ± 13.7 vs. 44.8 ± 16.2 years,p = 0.192), total burn size (3.1 ± 2.3 vs. 3.4 ± 2.8 %TBSA,p = 0.721) and treated wound size (1.9 ± 1.2 vs. 1.5 ± 0.8 %TBSA,p = 0.138). We found no differences regarding healing time (11.0 ± 4.9 vs. 8.6 ± 3.8,p = 0.074, and significant differences in a number of dressing changes throughout the study (2.4 ± 1.5 vs 4.2 ± 1.9,p < 0.001). The Kaplan-Meier time-to-event analysis exhibited no statistically significant difference in the time to healing or skin grafting (p = 0.085) in NPWT group compared with SOC group. The median time to healing or skin grafting was 10(8-11) days for NPWT and 9(7-11) days for SOC. The hazard ratio for healing or skin graft was HR= 0.64(0.38-1.08). The results of the time-to-event analysis as well as the Kaplan-Meier curve on the PPS confirmed this result. We found no differences in secondary surgical operations 15.2 vs 21.4 % pain or functional outcomes.
CONCLUSIONS: In this study, we found no significant difference between the two groups in terms of time to detect wound healing. We also found no difference regarding further operations for wound closure, pain and/or scarring. However, dressing changes were significantly less frequent for patients that were treated with NPWT, which may be a psychological and logistical advantage.
METHODS: Patients that were admitted to our institution between May 2019 and November 2021 with burns on extremities between 0.5 % and 10 % of the total body surface area (%TBSA) were included and randomized to either NPWT or SOC (polyhexanide gel, fatty gauze, and cotton wool). Treatment was performed until complete wound healing. Patients that required skin grafts, received additional NPWT after grafting independent on the initial group allocation.
RESULTS: Sixty-five patients suffering from burn injury between May 2019 and November 2021 were randomized into treatment with NPWT (n = 33) or SOC (n = 32); of these, 33 patients (NPWT) and 28 patients (SOC) had complete data sets and were included in the analysis. Both groups were similar regarding age (39.8 ± 13.7 vs. 44.8 ± 16.2 years,p = 0.192), total burn size (3.1 ± 2.3 vs. 3.4 ± 2.8 %TBSA,p = 0.721) and treated wound size (1.9 ± 1.2 vs. 1.5 ± 0.8 %TBSA,p = 0.138). We found no differences regarding healing time (11.0 ± 4.9 vs. 8.6 ± 3.8,p = 0.074, and significant differences in a number of dressing changes throughout the study (2.4 ± 1.5 vs 4.2 ± 1.9,p < 0.001). The Kaplan-Meier time-to-event analysis exhibited no statistically significant difference in the time to healing or skin grafting (p = 0.085) in NPWT group compared with SOC group. The median time to healing or skin grafting was 10(8-11) days for NPWT and 9(7-11) days for SOC. The hazard ratio for healing or skin graft was HR= 0.64(0.38-1.08). The results of the time-to-event analysis as well as the Kaplan-Meier curve on the PPS confirmed this result. We found no differences in secondary surgical operations 15.2 vs 21.4 % pain or functional outcomes.
CONCLUSIONS: In this study, we found no significant difference between the two groups in terms of time to detect wound healing. We also found no difference regarding further operations for wound closure, pain and/or scarring. However, dressing changes were significantly less frequent for patients that were treated with NPWT, which may be a psychological and logistical advantage.
摘要：
背景：负压伤口疗法（NPWT）已成为广泛用于覆盖和积极治疗复杂伤口的工具，包括烧伤.这项研究旨在评估NPWT在上肢和下肢急性烧伤中的有效性，并将结果与我们机构的标准护理（SOC）进行比较。
方法：在2019年5月至2021年11月期间收治的四肢烧伤占全身表面积（％TBSA）的0.5％至10％之间的患者被纳入本机构，并随机分配至NPWT或SOC（聚己内酯凝胶，脂肪纱布,和棉绒）。进行治疗直至伤口完全愈合。需要皮肤移植的患者，移植后接受额外的NPWT，与初始组分配无关。
结果：在2019年5月至2021年11月期间，65例烧伤患者被随机分配到NPWT（n=33）或SOC（n=32）治疗中；其中，33例患者（NPWT）和28例患者（SOC）具有完整的数据集，并包括在分析中。两组的年龄相似（39.8±13.7vs.44.8±16.2年，p=0.192)，总烧伤大小(3.1±2.3vs.3.4±2.8%TBSA，p=0.721）和治疗的伤口大小（1.9±1.2vs.1.5±0.8%TBSA,p=0.138）。我们发现愈合时间没有差异（11.0±4.9与8.6±3.8，p=0.074，并且在整个研究中敷料更换次数存在显着差异（2.4±1.5vs4.2±1.9，p<0.001）。Kaplan-Meier事件时间分析显示，与SOC组相比，NPWT组的愈合时间或植皮时间差异无统计学意义（p=0.085）。NPWT愈合或植皮的中位时间为10（8-11）天，SOC为9（7-11）天。愈合或皮肤移植的风险比为HR=0.64（0.38-1.08）。时间-事件分析的结果以及PPS上的Kaplan-Meier曲线证实了该结果。我们发现，在二次外科手术中，15.2与21.4％的疼痛或功能结局没有差异。
结论：在这项研究中，我们发现在检测伤口愈合的时间方面，两组之间没有显着差异。我们还发现伤口闭合的进一步手术没有区别，疼痛和/或疤痕。然而,对于接受NPWT治疗的患者，换药频率明显较低，这可能是一种心理和后勤优势。
方法：在2019年5月至2021年11月期间收治的四肢烧伤占全身表面积（％TBSA）的0.5％至10％之间的患者被纳入本机构，并随机分配至NPWT或SOC（聚己内酯凝胶，脂肪纱布,和棉绒）。进行治疗直至伤口完全愈合。需要皮肤移植的患者，移植后接受额外的NPWT，与初始组分配无关。
结果：在2019年5月至2021年11月期间，65例烧伤患者被随机分配到NPWT（n=33）或SOC（n=32）治疗中；其中，33例患者（NPWT）和28例患者（SOC）具有完整的数据集，并包括在分析中。两组的年龄相似（39.8±13.7vs.44.8±16.2年，p=0.192)，总烧伤大小(3.1±2.3vs.3.4±2.8%TBSA，p=0.721）和治疗的伤口大小（1.9±1.2vs.1.5±0.8%TBSA,p=0.138）。我们发现愈合时间没有差异（11.0±4.9与8.6±3.8，p=0.074，并且在整个研究中敷料更换次数存在显着差异（2.4±1.5vs4.2±1.9，p<0.001）。Kaplan-Meier事件时间分析显示，与SOC组相比，NPWT组的愈合时间或植皮时间差异无统计学意义（p=0.085）。NPWT愈合或植皮的中位时间为10（8-11）天，SOC为9（7-11）天。愈合或皮肤移植的风险比为HR=0.64（0.38-1.08）。时间-事件分析的结果以及PPS上的Kaplan-Meier曲线证实了该结果。我们发现，在二次外科手术中，15.2与21.4％的疼痛或功能结局没有差异。
结论：在这项研究中，我们发现在检测伤口愈合的时间方面，两组之间没有显着差异。我们还发现伤口闭合的进一步手术没有区别，疼痛和/或疤痕。然而,对于接受NPWT治疗的患者，换药频率明显较低，这可能是一种心理和后勤优势。
