Effect of Irrigation of Triamcinolone Versus Hypertonic Saline in Decreasing Seroma Post Abdominoplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- number of abdominoplasty patients having seroma after intraoperative Triamcinolone irrigation
研究概览
简要总结
A total of 90 abdominoplasty patients were randomly assigned into three groups:
Group A: Triamcinolone group, Group B: Hypertonic saline group, Group C: Control group
Randomization:
It was performed using the closed envelope technique.
Technique:
After performing a Lipo-abdominoplasty Group A (triamcinolone) irrigates 10 cm saline mixed with two 40 mg vials through the umbilicus into dead space; Group B (hypertonic saline) irrigates 20 cm of 10% solution similarly; Group C (control) receives no irrigation
详细描述
A total of 90 patients were recruited in this study from November 2023 until July 2025. These patients presented to the outpatient clinic of the Plastic and Reconstructive Surgery Department, Kasr Al ainy Hospital with pendulous abdomen or manifestations of myofascial abdominal laxity and weakness or more commonly, a combination of both. In additions, almost all patients were complaining of localized stubborn fat deposits usually in the flank and epigastric areas that also needed to be addressed.
Randomization:
It was performed using . Opaque, sealed and sequentially numbered envelopes containing group assignments were prepared by an independent participant not enrolled in the study. Each envelope was opened only after a participant enrollment, ensuring allocation concealment and preventing selection bias.
Pre-operative: Before admission, patients were consented on the study methodology and the randomization process. The initial consultation of our patients revolved around the expected procedural details, the preoperative preparatory steps and the post-operative recovery time and details. Afterwards, proper history and examination were conducted along with routine preoperative labs and abdominal ultrasound to detect hernial defects.
Preoperative markings: In the standing position, after proper exposure of the trunk area, Markings of the liposuction area over the back were done. Followed by anterior markings which begins with identifying the anterior midline and marking both linae semilunaris while the patient contracts the rectus abdominis muscles. Next, the lateral ends of the expected abdominal scars are marked at the abdominal fold with the patient flexing the trunk 30 degrees. The midpoint of the proposed incision site is then marked in the midline at 6-8 cm under medium stretch, confirmed at 8-10 cm under maximum stretch. Measurements of 7 cm lateral to the midline at this site and 9 cm from the midline above the umbilicus are taken, ensuring these points coincide during closure for 2 cm abdominal flap medialization. This midpoint connects laterally to the 7 cm marking and then to the proposed incision ends. Using a pinch test, the proposed upper incision is marked in the midline above the umbilicus and connected to the lateral ends of the proposed lower incision. Finally, areas for liposuction in the anterior flanks and epigastrium are marked.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pendulous abdomen grades 3 and 4 according to the Matarasso classification of 1991.
排除标准
- •Age: < 18 years and > 65 years
- •BMI: >39.1
- •Known allergies to steroidal compounds
- •Uncontrolled medical comorbidities
- •open abdominal surgeries other than caesarian sections.
- •Ventral hernias
- •Ehlers-Danlos and other hyper elasticity syndromes
结局指标
主要结局
number of abdominoplasty patients having seroma after intraoperative Triamcinolone irrigation
时间窗: 8 weeks
number of patients having seroma after irrigation of 10 cc of saline 0.9% mixed with 80 mg triamcinolone
number of abdominoplasty patients having seroma after intraoperative hypertonic saline irrigation
时间窗: 8 weeks
number of patients having seroma after irrigation of 20cc of 10% hypertonic saline
次要结局
- days needed to remove the drain post abdominoplasty after intraoperative triamcinolone irrigation(up to 15 days)
- Days needed to remove the drain post abdominoplasty after intraoperative Hypertonic saline irrigation(Up to 15 days)
- total amount of seroma, measured in cc, in patients who develop seroma after intraoperative Triamcinolone irrigation following abdominoplasty(8 weeks)
- total amount of seroma, measured in cc, in patients who develop seroma after intraoperative hypertonic saline irrigation following abdominoplasty(8 weeks)
- total drain output, measured in cc, post abdominoplasty after intraoperative triamcinolone irrigation(up to 15 days)
- total drain output, measured in cc, post abdominoplasty after intraoperative hypertonic saline irrigation(up to 15 days)
研究者
Hamed M. Kadry
Professor Of Plastic & Reconstructive Surgery
Cairo University
