Sonnichsen K, Isberg P-E, Elers J, Zaigham M, Wiberg Nana
Department of Obstetrics and Gynecology, Skåne University Hospital, Malmö and Lund, Sweden.
Department of Statistics, Lund University, Lund, Sweden.
Matern Health Neonatol Perinatol. 2025 May 5;11(1):13. doi: 10.1186/s40748-025-00211-0.
Preventing infection in primary sutured perineal tears after childbirth is crucial to avoid systemic antibiotic use and potential complications from poor healing. This study aimed to investigate the efficacy of an antibacterial, triclosan-coated suture (VicrylPlus) in reducing infection in primary sutured childbirth-related perineal tears.
The PLUS study was a single-center, single-blinded, adaptive parallel-group randomized trial conducted at Lund University Hospital, Sweden. Women aged ≥ 18 years with a perineal tear at childbirth were randomly assigned in a 1:1 ratio to either the control group (conventional-absorbable suture, Vicryl) or the intervention group (triclosan-coated- absorbable suture, VicrylPlus).
Out of 1921 eligible women, 1890 were randomized to either Vicryl (n = 953) or VicrylPlus (n = 937). There were no significant demographic differences between the groups. The most common type of tear in both groups was a second-degree tear (Vicryl 66.2% (n = 625), VicrylPlus 67.5% (n = 625)). Encompassing all types of deeper tears in the analysis there was a significantly decrease in infection after suturing with VicrylPlus 4% (n = 28) versus Vicryl 6.8% (n = 47); (OR 0.57, 95% CI 0.35-0.91, P = 0.024). When analyzing different tears separately, there was a non-significant increase in infection for first-degree tears with VicrylPlus 0.8% (n = 2) versus Vicryl 3.9% (n = 8); (OR 4.75, 95% CI 1.00-22.63, P = 0.050). However, for second-degree tears, the infection rate was significantly reduced with VicrylPlus 4.4% (n = 27) versus Vicryl 7.2% (n = 44); (OR 0.63, 95% CI 0.36-0.98, P = 0.05) and for third-degree and unclassified tears there was a non-significant decrease in infections with VicrylPlus 5.3% (n = 1) versus Vicryl 14.3% (n = 2); (OR 0.33, 95% CI 0.03-4.10, P = 0.561), respectively, VicrylPlus 0% versus Vicryl 1.7% (n = 1); (OR 0.98, 95% CI 0.95-1.02, P = 0.462).
The use of triclosan coated sutures significantly reduces the risk of infection in primary sutured childbirth-related perineal tears by 43%, except for first-degree tears. Further research is needed to determine whether their effectiveness remains consistent across the other specific types of deeper tears in a larger study population.
ClinicalTrials (NCT02863874), posted 11/08/2016, retrospectively registered. Approved by the regional ethical committee before start of enrollment (Dnr 2015/774).
预防产后一期缝合会阴撕裂的感染对于避免全身性使用抗生素以及因愈合不良引发的潜在并发症至关重要。本研究旨在调查抗菌性三氯生涂层缝线（VicrylPlus）在降低一期缝合的分娩相关会阴撕裂感染方面的疗效。
PLUS研究是在瑞典隆德大学医院进行的一项单中心、单盲、适应性平行组随机试验。年龄≥18岁且分娩时有会阴撕裂的女性按1:1比例随机分配至对照组（传统可吸收缝线，Vicryl）或干预组（三氯生涂层可吸收缝线，VicrylPlus）。
在1921名符合条件的女性中，1890名被随机分配至Vicryl组（n = 953）或VicrylPlus组（n = 937）。两组之间在人口统计学方面无显著差异。两组中最常见的撕裂类型均为二度撕裂（Vicryl组66.2%（n = 625），VicrylPlus组67.5%（n = 625））。在分析所有类型的深度撕裂时，VicrylPlus组缝合后感染率显著降低，为4%（n = 28），而Vicryl组为6.8%（n = 47）；（比值比0.57，95%置信区间0.35 - 0.91，P = 0.024）。分别分析不同类型撕裂时，一度撕裂中VicrylPlus组感染率有非显著增加，为0.8%（n = 2），而Vicryl组为3.9%（n = 8）；（比值比4.75，95%置信区间1.00 - 22.63，P = 0.050）。然而，对于二度撕裂，VicrylPlus组感染率显著降低，为4.4%（n = 27），而Vicryl组为7.2%（n = 44）；（比值比0.63，95%置信区间0.36 - 0.98，P = 0.05），对于三度和未分类撕裂，VicrylPlus组感染率有非显著降低，分别为5.3%（n = 1）和Vicryl组14.3%（n = 2）；（比值比0.33，95%置信区间0.03 - 4.10，P = 0.561），VicrylPlus组为0%，Vicryl组为1.7%（n = 1）；（比值比0.98，95%置信区间0.95 - 1.02，P = 0.462）。
使用三氯生涂层缝线可显著降低一期缝合的分娩相关会阴撕裂的感染风险达43%，一度撕裂除外。需要进一步研究以确定在更大规模研究人群中，其在其他特定类型深度撕裂中的有效性是否保持一致。
ClinicalTrials（NCT02863874），于2016年8月11日发布，回顾性注册。在入组开始前经地区伦理委员会批准（编号2015/774）。
