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临床试验/NCT05490602
NCT05490602进行中(未招募)不适用

Comparison Study in Different Sutures Techniques in Reduction of Known Abdominoplasty Complications and Improving Patients' Post-operative Outcomes

Brugmann University Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年3月8日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
100
试验地点
1
主要终点
Visual assessment of the wound

研究概览

简要总结

After an important weight loss abdominoplasty has become one of the most frequent interventions to remove excess skin to achieve the best cosmetic and body perception psychological results after weight loss. The American Society of Plastic surgeons have published documents in 2004 indicating a 344% increase in the number of abdominoplasty cases.

Dog ears is one of the classical complications in body contouring and abdominoplasty which needs a scar revision to achieve the optimum cosmetic result. It's due to bad tension from the closed scar.

In a classical abdominoplasty wound closure subcuticular, (or intradermal) sutures can be interrupted or placed in a running fashion. Such a technique obviates the need for external skin sutures and circumvents the possibility of suture marks in the skin. Other techniques have been described in the literature to reduce abdominoplasty complication (seroma, hematoma, infection, dog ear, flap necrosis etc.. ) such as classical high lateral tension and lipo-aspiration on preventing dog ears and elongation scar was evaluated and progressive tension sutures. The running subcutaneous sutures that consist of running sutures in the profound and superficial dermis without knotting the thread(suture) showed less dog ears occurrence and other complications which leads to more patient satisfaction and less scar revision. Dog ear is referred to as a puckering of the skin that appears sometimes at the end of a scar, especially after procedures that involve some degree of skin tightening or when skin after the end of the scar is looser than skin along the scar itself creating a small excess of skin where the incision ends.

So far there's no reported epidemiology for dog ears in the literature, however it's mentioned in some papers where it's a common complication and reason for scar revision in abdominoplasty and breast reduction surgery.

The aim of this study is to compare the incidence of dog ear and other complications in classical abdominoplasty closure to running subcutaneous sutures, method, which decreases dog ear incidence, wound dehiscence, infection and hypertrophic scar which are actually quite common after abdominoplasty. This allows to avoid a scar correction surgery and have a better aesthetic outcome. The investigators also evaluate the amelioration of sexual activity after a pubis-pexy using SAQ(Sexual Activity Questionnaire).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Adult women at our department undergoing primary abdominoplasty with transposition of umbilicus with or without liposuction

排除标准

  • Age <18 or >65 years
  • History of chemotherapy
  • Smoker patient, diabetic patient
  • Male patient
  • < 6 months postpartum
  • Non-compliant patient

结局指标

主要结局

Visual assessment of the wound

时间窗: 1 year post surgery

Pre-operative and post-operative photography will be taken in both groups allowing a visual assessment of the result. The end results will be examined by a third blinded party without a previous knowledge of which technique was used.

Pinch fat of dog ears

时间窗: 1 year post surgery

Absence/presence of dog ears. Dog ears is one of the classical complications in body contouring and abdominoplasty which needs a scar revision to achieve the optimum cosmetic result. It's due to bad tension from the closed scar.

Sexual Activity questionnaire

时间窗: 1 year post surgery

The sexual activity questionnaire is a 20-item tool that is focused on the relational, emotional, and behavioral aspects of sexual activity in the general population. Each question is rated using a four-point Likert scale from 0 to 3 (0 : not at all, and 3 : very much)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Socorro ORTIZ

Head of plastic surgery department

Brugmann University Hospital

研究点 (1)

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