Department of Surgical Affairs, Royal College of Surgeons in Ireland, Dublin, Republic of Ireland.
National Surgical Research Support Centre (NSRSC), Dublin, Republic of Ireland.
BJS Open. 2024 Jul 2;8(4). doi: 10.1093/bjsopen/zrae081.
A proportion of patients undergoing midline laparotomy will develop surgical site infections after surgery. These complications place considerable financial burden on healthcare economies and have negative implications for patient health and quality of life. The prophylactic application of negative pressure wound therapy devices has been mooted as a pragmatic strategy to reduce surgical site infections. Nevertheless, further availability of multicentre randomized clinical trial data evaluating the prophylactic use of negative pressure wound therapy following midline laparotomy is warranted to definitely provide consensus in relation to these closure methods, while also deciphering potential differences among subgroups. The aim of this study is to determine whether prophylactic negative pressure wound therapy reduces postoperative wound complications in patients undergoing midline laparotomy.
PROPEL-2 is a multicentre prospective randomized clinical trial designed to compare standard surgical dressings (control arm) with negative pressure wound therapy dressings (Prevena™ and PICO™ being the most commonly utilized). Patient recruitment will include adult patients aged 18 years or over, who are indicated to undergo emergency or elective laparotomy. To achieve 90% power at the 5% significance level, 1006 patients will be required in each arm, which when allowing for losses to follow-up, 10% will be added to each arm, leaving the total projected sample size to be 2013 patients, who will be recruited across a 36-month enrolment period.
The PROPEL-2 trial will be the largest independent multicentre randomized clinical trial designed to assess the role of prophylactic negative pressure wound therapy in patients indicated to undergo midline laparotomy. The comparison of standard treatment to two commercially available negative pressure wound therapy devices will help provide consensus on the routine management of laparotomy wounds. Enrolment to PROPEL-2 began in June 2023. Registration number: NCT05977816 (http://www.clinicaltrials.gov).
一部分接受中线剖腹术的患者术后会发生手术部位感染。这些并发症给医疗经济带来了相当大的负担，对患者的健康和生活质量也有负面影响。预防性应用负压伤口治疗装置已被提出作为减少手术部位感染的一种实用策略。然而，需要更多的多中心随机临床试验数据来评估中线剖腹术后预防性应用负压伤口治疗，以明确提供这些闭合方法的共识，同时也解析亚组之间的潜在差异。本研究旨在确定预防性应用负压伤口治疗是否能减少接受中线剖腹术患者的术后伤口并发症。
PROPEL-2 是一项多中心前瞻性随机临床试验，旨在比较标准手术敷料（对照组）与负压伤口治疗敷料（Prevena™ 和 PICO™ 是最常用的两种）。患者招募将包括年龄在 18 岁或以上的成年患者，这些患者需要接受紧急或择期剖腹术。为了在 5%的显著性水平上达到 90%的效力，每个臂需要 1006 例患者，考虑到随访丢失，每个臂将增加 10%，总预计样本量为 2013 例患者，将在 36 个月的入组期内招募。
PROPEL-2 试验将是最大的独立多中心随机临床试验，旨在评估预防性应用负压伤口治疗在需要接受中线剖腹术的患者中的作用。将标准治疗与两种市售的负压伤口治疗装置进行比较，将有助于就剖腹术伤口的常规管理达成共识。PROPEL-2 的入组于 2023 年 6 月开始。注册号：NCT05977816（http://www.clinicaltrials.gov）。
