Casanova Dominique, Guerreschi Pierre, Sinna Raphael, Bertheuil Nicolas, Philandrianos Cécile, Chignon-Sicard Bérengère, Duteille Franck, Atlan Michael, Rousseau Pascal, Chatellier Gilles, Boucher Fabien, Pham Dang Nathalie, Cambon-Binder Adeline, Michot Audrey, Pluvy Isabelle, Seigle-Murandi Frédéric, Hu Weiguo, Revol Marc
Department of Plastic and Reconstructive Surgery, Hospital Conception, Marseille, France.
Department of Plastic, Cosmetic and Reconstructive Surgery, Regional and University Hospital Centre Lille, Lille, France.
Plast Reconstr Surg Glob Open. 2020 Mar 27;8(3):e2691. doi: 10.1097/GOX.0000000000002691. eCollection 2020 Mar.
A calcium alginate dressing (ALGINATE) and negative pressure wound therapy (NPWT) are frequently used to treat wounds which heal by secondary intention. This trial compared the healing efficacy and safety of these 2 treatments.
This randomized, non-inferiority trial enrolled patients who underwent skin excision (>30 cm), which was left open to heal by secondary intention. They received ALGINATE or NPWT by a centralized randomization. Follow-up was performed weekly until optimal granulation tissue was obtained. The primary outcome was time to obtain optimal granulation tissue for a split thickness skin graft take (non-inferiority margin: 4 days). Secondary outcomes were occurrence of adverse events (AEs) and impact of the treatments on the patient's daily life.
ALGINATE and NPWT were applied to 47 and 48 patients, respectively. The mean time to optimal granulation was 19.98 days (95% CI, 17.7-22.3) with ALGINATE and 20.54 (95% CI, 17.6-23.5) with NPWT. Between group difference was -0.56 days (95% CI -4.22 to 3.10). The non-inferiority of ALGINATE versus NPWT was demonstrated. No AE related to the treatment occurred with ALGINATE versus 14 AEs with NPWT. There was no difference in the impact of the treatments on the patient's daily life.
This trial demonstrates that ALGINATE has a similar healing efficacy to that of NPWT and that is markedly better with regard to patient safety.
藻酸钙敷料（ALGINATE）和负压伤口治疗（NPWT）常用于治疗通过二期愈合的伤口。本试验比较了这两种治疗方法的愈合效果和安全性。
本随机、非劣效性试验纳入了接受皮肤切除（>30 cm）且伤口敞开通过二期愈合的患者。通过集中随机分组，他们接受ALGINATE或NPWT治疗。每周进行随访，直至获得最佳肉芽组织。主要结局是获得用于取中厚皮片的最佳肉芽组织的时间（非劣效界值：4天）。次要结局是不良事件（AE）的发生情况以及治疗对患者日常生活的影响。
分别对47例和48例患者应用了ALGINATE和NPWT。使用ALGINATE时，达到最佳肉芽组织的平均时间为19.98天（95%CI，17.7 - 22.3），使用NPWT时为20.54天（95%CI，17.6 - 23.5）。组间差异为 -0.56天（95%CI -4.22至3.10）。证明了ALGINATE相对于NPWT的非劣效性。使用ALGINATE时未发生与治疗相关的AE，而使用NPWT时发生了14例AE。两种治疗方法对患者日常生活的影响无差异。
本试验表明，ALGINATE与NPWT具有相似的愈合效果，且在患者安全性方面明显更好。
