Overview
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.
Description
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.
Eligibility
Inclusion Criteria:
- Age 18 years or older.
- Vietnamese nationality.
- Indication for laparoscopic colectomy.
- Willing and able to provide written informed consent to participate in the study.
Exclusion Criteria:
- 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.
