An interventional study of Botulinum toxin type A (Botox®, Allergan) in Surgical Wound Healing and Botulinum Toxin, Type A, sponsored by Pham Ngoc Thach University of Medicine. Recruiting at 1 site in Vietnam. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by Pham Ngoc Thach University of Medicine · Not applicable, Interventional, and Treatment
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.
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.
315 studies on the registry are indexed under Surgical Wound; 57 are open to participants now.
This study's planned enrollment of 60 is close to the median of 66 across 242 interventional studies indexed under Surgical Wound.
Browse Surgical Wound studies →Pham Ngoc Thach University of Medicine is the lead sponsor of 9 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Botulinum toxin type A (Botox®, Allergan)
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.
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.
Early surgical wound healing assessed by the REEDA scale
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.
Time frame: Postoperative days 0, 7, and 14
Scar appearance assessed by the modified Stony Brook Scar Evaluation Scale (mSBSES)
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.
Time frame: Postoperative days 7, 14, and 30
Incidence of adverse events associated with botulinum toxin type A injection
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.
Time frame: From the time of BTX-A administration through postoperative day 30
Plan to share: No
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Studies of the drug tested here: Botulinum toxin type A
Pham Ngoc Thach University of Medicine