2025-522410-23-00招募中4 期
Botulinum toxin in open abdomen closure. A multicentric randomized controlled single-blind clinical trial to evaluate the efficacy of early administration of botulinum toxin for primary midline closure in patients with an open abdomen.
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 5
- 主要终点
- Proportion (%) of patients achieving approximation of the middle fascial edges with sutures, regardless of adjunctive measures (e.g. traction sutures or temporary meshes), provided that definitive bridging with a permanent mesh is not used.
研究概览
简要总结
To demonstrate the efficacy of botulinum toxin in the primary midline closure of patients with an open abdomen compared to placebo within 20 days.
研究设计
- 分配方式
- Randomized
- 主要目的
- Randomized, single-blind, placebo-controlled, multicenter, phase IV, low-intervention clinical trial
- 盲法
- Single (Subject)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Subjects capable of understanding the study's purpose and risks, providing written informed consent and authorising the use of confidential health information in accordance with applicable regulations.
- •If the patient cannot provide consent due to an emergency status, consent will be obtained from a first- or second-degree relative. If the patient regains decision-making capacity, consent will be requested to continue participation.
- •Patients aged 18 years or older at the time of inclusion.
- •Patients who have undergone abdominal surgery resulting in an open abdomen per clinical practice, in whom administration of the investigational treatment is feasible within 48 hours after the procedure that led to the open abdomen.
- •Subjects willing and able to participate and comply with study procedures and follow-up visits for most of the study duration.
排除标准
- •Participants are not willing or able to comply with either: all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, or other study procedures.
- •Presence of conditions potentially interfering or worsening with botulinum toxin use (e.g., hyperthyroidism, neuromuscular disease, myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis).
- •Known hypersensitivity to botulinum toxin.
- •Active neoplastic disease.
- •Pregnant or breastfeeding women, where pregnancy is defined as the state of a female after conception and until the termination of gestation.
- •Any condition or situation which, in the opinion of the investigator, may interfere with the efficacy and/or safety evaluation of the trial.
- •Patients with severe uncorrected coagulopathy or bleeding disorders (prolonged bleeding times) that, in the opinion of the investigator, contraindicate intramuscular injections.
研究组 & 干预措施
DYSPORT 500 U POLVO PARA SOLUCIÓN INYECTABLE
Test
干预措施: DYSPORT 500 U POLVO PARA SOLUCIÓN INYECTABLE (Drug)
Suero fisiológico al 0,9%
Placebo
干预措施: Suero fisiológico al 0,9% (Drug)
结局指标
主要结局
Proportion (%) of patients achieving approximation of the middle fascial edges with sutures, regardless of adjunctive measures (e.g. traction sutures or temporary meshes), provided that definitive bridging with a permanent mesh is not used.
Proportion (%) of patients achieving approximation of the middle fascial edges with sutures, regardless of adjunctive measures (e.g. traction sutures or temporary meshes), provided that definitive bridging with a permanent mesh is not used.
次要结局
- Incidence of treatment-emergent adverse events potentially related to botulinum toxin (e.g., clinically relevant muscle weakness, injection-site reactions), serious adverse events, and all-cause mortality through day 30.
- Time (in days) from the open-abdomen procedure to primary midline fascial closure or to planned ventral hernia is established (not total midline closure but skin closure).
- Incidence of midline continuity defect (incisional hernia) confirmed by physical examination and/or imaging at 6 months.
- Mean number of patients achieving the primary objective with botulinum toxin administration within the first 24 hours compared to those administered between 24 and 48 hours.
- Incidence of respiratory complications (distress, atelectasis, prolonged intubation, reintubation within 72 hours or oxygen requirements) during acute hospitalization.
- SF-36 questionnaire results at 1 and 6-month follow-up.
- Incidence of surgical site infections based on the day of midline closure since the open abdomen, measured over 30 days without mesh and 90 days with mesh.
研究者
Luis Asensio Gómez
Scientific
Hospital Universitario La Paz
研究点 (5)
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