Ponce Jordi, García-Tejedor Amparo, Barahona Marc, Cappuccio Serena, Costantini Barbara, Fedele Camilla, Marti-Cardona Lola, Scambia Giovanni
Gynecology Department, University Hospital of Bellvitge (IDIBELL), Hospitalet de Llobregat, Barcelona, Spain.
IDIBELL (Instituto de Investigación Biomédica de Bellvitge), Hospitalet de Llobregat, Barcelona, Spain.
PLoS One. 2025 Sep 11;20(9):e0331376. doi: 10.1371/journal.pone.0331376. eCollection 2025.
To evaluate the safety and effectiveness of an absorbable modified polymer starch powder hemostat (AMP-SPH) compared with standard care to control hemostasis when used in adult subjects during open or laparoscopic gynecological procedures for both benign and malignant diseases. Methods: Prospective, multi-center, randomized, and interventional phase IV study conducted on consecutive patients, aged ≥18 years, who underwent an open or laparoscopic gynecological procedure between November 2015 and July 2017 in a third-level Hospital. Study participants were randomly assigned (1:1) to receive either treatment with an AMP-SPH (AMP group) or usual standard care (SC group). The hemostatic treatment administered to the SC group was at the investigator's discretion. The primary effectiveness endpoint of the study was the achievement of hemostasis (yes/no) within 10 minutes. Results: Ninety patients, 44 (48.9%) in the AMP group and 46 (51.1%) in the SC group were included in the analysis. the AMP group, 97.7% (43/44) of patients achieved hemostasis as compared to the 93.5% (43/46) of subjects in the SC group (mean difference: 4.2%; 95%CI: -4.1% to 12.6%; p = .337). The time required to achieve hemostasis was lower in the AMP group (1.91 ± 1.15 minutes) than in the SC group (2.28 ± 2.09 minutes), although not significant (p = .309). A higher proportion of patients in the SC group (17.9%) was observed to require blood products compared to those in the AMP group (4.8%).A total of 29 adverse events (AEs) (24 non-serious and 5 serious AEs) were reported, 12 AEs in the AMP group and 17 in the SC group.
According to the results of this study, AMP-SPH was not inferior to standard care in the control of bleeding for patients undergoing gynecology procedures and the cessation of bleeding was trending to be faster with the use of AMP-SPH than with standard methods.
ClinicalTrials.gov NCT02835391.
评估可吸收改性聚合物淀粉粉末止血剂（AMP-SPH）与标准护理相比，在成人良性和恶性疾病的开放或腹腔镜妇科手术中用于控制止血的安全性和有效性。方法：对2015年11月至2017年7月在一家三级医院接受开放或腹腔镜妇科手术、年龄≥18岁的连续患者进行前瞻性、多中心、随机、干预性IV期研究。研究参与者被随机分配（1:1）接受AMP-SPH治疗（AMP组）或常规标准护理（SC组）。给予SC组的止血治疗由研究者自行决定。该研究的主要有效性终点是在10分钟内实现止血（是/否）。结果：90名患者纳入分析，AMP组44名（48.9%），SC组46名（51.1%）。在AMP组，97.7%（43/44）的患者实现了止血，而SC组为93.5%（43/46）的受试者（平均差异：4.2%；95%CI：-4.1%至12.6%；p = 0.337）。AMP组实现止血所需时间（1.91±1.15分钟）低于SC组（2.28±2.09分钟），尽管差异不显著（p = 0.309）。观察到SC组中需要血液制品的患者比例（17.9%）高于AMP组（4.8%）。共报告了29起不良事件（AE）（24起非严重AE和5起严重AE），AMP组12起AE，SC组17起。结论：根据本研究结果，AMP-SPH在妇科手术患者的出血控制方面不劣于标准护理，并且使用AMP-SPH比标准方法止血趋势更快。试验注册：ClinicalTrials.gov NCT02835391。
