Milcheski Dimas A, Clivatti Gustavo M, Santos Junior Rafael A, González Carol V S, Monteiro Araldo A, Gemperli Rolf
Division of Plastic Surgery, Faculty of Medicine, University of São Paulo, São Paulo, Brazil.
Graduate Program in Adult Health Nursing at the University of São Paulo School of Nursing (Universidade de São Paulo, Escola de Enfermagem-EEUSP) São Paulo, São Paulo, Brazil.
J Plast Reconstr Aesthet Surg. 2025 Jan;100:208-218. doi: 10.1016/j.bjps.2024.11.005. Epub 2024 Nov 17.
Acute traumatic wounds often require prolonged healing time and hospitalization. Negative-pressure wound therapy with instillation and dwell time (NPWTi-d) has demonstrated effectiveness in accelerating patient healing over traditional NPWT, and its benefits are well established in the treatment of chronic infected wounds. However, randomized studies examining the use of NPWTi-d in acute traumatic wounds are scarce. This study aimed to examine the effectiveness of NPWTi-d compared to traditional gauze layer dressing and standard NPWT.
This single-center, randomized, pragmatic, controlled clinical trial included 120 adult patients with acute traumatic wounds from traffic accidents randomized to NPWTi-d (n = 39), NPWT (n = 41), and gauze dressing (n = 40). Following surgical debridement of the wound bed, all patients underwent definitive wound closure with delayed primary closure, skin grafting, or surgical flaps. The primary outcomes were wound closure time, number of surgical procedures, and hospital length of stay. The secondary outcomes were primary closure type, amputations, complications, and death.
Wound closure time was significantly lower in patients with NPWTi-d compared to patients with NPWT and gauze dressing (6.1 vs. 10 vs. 11.7 days, respectively; p < 0.001). Patients with NPWTi-d had fewer surgical procedures than patients with NPWT and gauze dressing (3.0 vs. 3.5 vs. 6.2, respectively; p < 0.001). No significant differences in length of stay were observed among the groups.
In this study, patients with acute traumatic wounds who received NPWTi-d experienced shorter wound closure time and fewer surgical procedures than patients who received NPWT or gauze dressing.
The current study is registered on the Brazilian Clinical Trials Registry (ReBec) platform under the name Comparison between Traditional Dressing, V.A.C. Dressing and V.A.C. Dressing with Instillation in Complex Wounds, ID nº RBR-658g535 at https://ensaiosclinicos.gov.br/rg/RBR-658g535.
急性创伤性伤口通常需要较长的愈合时间和住院时间。带灌注和驻留时间的负压伤口治疗(NPWTi-d)已证明在加速患者愈合方面比传统的负压伤口治疗(NPWT)更有效,并且其在慢性感染伤口治疗中的益处已得到充分证实。然而,关于NPWTi-d在急性创伤性伤口中应用的随机研究很少。本研究旨在比较NPWTi-d与传统纱布层敷料和标准NPWT的有效性。
这项单中心、随机、实用、对照临床试验纳入了120名因交通事故导致急性创伤性伤口的成年患者,随机分为NPWTi-d组(n = 39)、NPWT组(n = 41)和纱布敷料组(n = 40)。在对伤口床进行手术清创后,所有患者均采用延迟一期缝合、皮肤移植或手术皮瓣进行确定性伤口闭合。主要结局指标为伤口闭合时间、手术次数和住院时间。次要结局指标为一期闭合类型、截肢情况、并发症和死亡情况。
与NPWT组和纱布敷料组患者相比,NPWTi-d组患者的伤口闭合时间显著缩短(分别为6.1天、10天和11.7天;p < 0.001)。NPWTi-d组患者的手术次数少于NPWT组和纱布敷料组患者(分别为3.0次、3.5次和6.2次;p < 0.001)。各组之间的住院时间未观察到显著差异。
在本研究中,与接受NPWT或纱布敷料治疗的患者相比,接受NPWTi-d治疗的急性创伤性伤口患者伤口闭合时间更短,手术次数更少。
本研究已在巴西临床试验注册平台(ReBec)上注册,名称为“复杂伤口中传统敷料、V.A.C.敷料和带灌注的V.A.C.敷料的比较”,注册号为RBR-658g535,网址为https://ensaiosclinicos.gov.br/rg/RBR-658g535 。