Efficacy and Safety of Botulinum Toxin Type A Injection for Surgical Wound Healing in Patients Undergoing Laparoscopic Colectomy at Thong Nhat Hospital, Ho Chi Minh City
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Early surgical wound healing assessed by the REEDA scale
研究概览
简要总结
This study aims to evaluate the efficacy and safety of botulinum toxin type A (BTX-A) injection as an adjunct to surgical wound healing in patients undergoing laparoscopic colectomy. Eligible participants are randomly assigned in a 1:1 ratio to either an intervention group receiving intradermal BTX-A injection along the surgical incision after wound closure or a control group receiving routine postoperative wound care without BTX-A injection. Wound healing and scar outcomes are evaluated during postoperative follow-up, and adverse events associated with BTX-A administration are monitored.
详细描述
This is a randomized controlled interventional study conducted in adult patients undergoing laparoscopic colectomy at Thong Nhat Hospital, Ho Chi Minh City, Vietnam. Participants who meet the eligibility criteria and provide written informed consent are enrolled in the study. After completion of surgery and closure of the specimen-extraction incision, eligible participants are randomly assigned in a 1:1 ratio to the intervention or control group using a pre-prepared randomization schedule.
Participants assigned to the intervention group receive intradermal botulinum toxin type A injections along the surgical incision. Participants assigned to the control group do not receive botulinum toxin type A and continue to receive routine postoperative wound care according to the hospital's standard clinical practice.
Participants are followed after surgery to evaluate wound healing, scar appearance, and the safety of botulinum toxin type A administration. The study compares wound-healing outcomes and adverse events between the intervention and control groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older.
- •Vietnamese nationality.
- •Indication for laparoscopic colectomy.
- •Willing and able to provide written informed consent to participate in the study.
排除标准
- •Pregnancy or breastfeeding.
- •History of allergy to botulinum toxin type A.
- •History of botulinum toxin type A injection at or near the surgical site within the previous 6 months.
- •History of radiotherapy, chemotherapy, hematologic disorders, psychiatric disorders, or myasthenia gravis.
- •Unstable chronic diseases, including uncontrolled hypertension or diabetes mellitus.
- •Unable to attend scheduled follow-up visits.
研究组 & 干预措施
Botulinum Toxin Type A Group
Participants receive intradermal botulinum toxin type A injection along the surgical incision after completion of laparoscopic colectomy and wound closure, in addition to routine postoperative wound care.
干预措施: Botulinum toxin type A (Botox®, Allergan) (Drug)
Control Group
Participants do not receive botulinum toxin type A injection and receive routine postoperative wound care according to the standard clinical practice of Thong Nhat Hospital.
结局指标
主要结局
Early surgical wound healing assessed by the REEDA scale
时间窗: Postoperative days 0, 7, and 14
Early surgical wound healing is assessed using the Redness, Edema, Ecchymosis, Discharge, and Approximation (REEDA) scale. The scale evaluates five components: redness, edema, ecchymosis, discharge, and approximation of the wound edges. Each component is scored from 0 to 3, resulting in a total score ranging from 0 to 15. Lower scores indicate better wound healing, whereas higher scores indicate poorer wound healing.
次要结局
- Scar appearance assessed by the modified Stony Brook Scar Evaluation Scale (mSBSES)(Postoperative days 7, 14, and 30)
- Incidence of adverse events associated with botulinum toxin type A injection(From the time of BTX-A administration through postoperative day 30)