Botulinum Toxin, Type A, Surgical Wound Healing
Conditions
Keywords
Botulinum Toxin Type A, Surgical Wound, Wound Healing, Surgical Scar, Laparoscopic Colectomy
Brief summary
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.
Detailed 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.
Interventions
Botulinum toxin type A (BTX-A) is administered by intradermal injection along both sides of the surgical incision at a dose of 5 units per injection point. Injection points are located approximately 5 mm from the wound edge and spaced approximately 1 cm apart. The injections are performed using a 1-mL insulin syringe with a 29-gauge needle. The procedure is performed by the same physician for all participants in the intervention group to ensure consistency of the injection technique. Participants subsequently receive routine postoperative wound care according to the standard treatment protocol of Thong Nhat Hospital.
Sponsors
Thong Nhat Hospital
Pham Ngoc Thach University of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Participants are randomly assigned in a 1:1 ratio to either botulinum toxin type A injection plus routine postoperative wound care or routine postoperative wound care alone.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early surgical wound healing assessed by the REEDA scale | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Scar appearance assessed by the modified Stony Brook Scar Evaluation Scale (mSBSES) | Postoperative days 7, 14, and 30 | Scar appearance is assessed using the modified Stony Brook Scar Evaluation Scale (mSBSES). The scale evaluates four components: scar width, scar height, scar color/redness, and visibility of the scar line. Each component is scored from 0 to 2, resulting in a total score ranging from 0 to 8. Higher scores indicate better cosmetic scar outcomes. |
| Incidence of adverse events associated with botulinum toxin type A injection | From the time of BTX-A administration through postoperative day 30 | Safety is assessed by recording local injection-site reactions and other complications following botulinum toxin type A administration. Local reactions include pain, bruising, and swelling or edema at the injection site. Other adverse events include muscle weakness extending beyond the injection site and systemic allergic reactions, including urticaria, dyspnea, or anaphylaxis. The number and proportion of participants experiencing one or more adverse events will be recorded. |
Countries
Vietnam
Contacts
CONTACTTo Trinh Ngoc Chau, MSc
Outcome results
None listed