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NCT Number: NCT07795463

Botulinum Toxin Type A for Wound Healing After Laparoscopic Colectomy

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.

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Key information

Conditions

Surgical Wound Healing Botulinum Toxin, Type A Surgical Wound Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thong Nhat hospital

Ho Chi Minh City, Vietnam

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Botulinum toxin type A (Botox®, Allergan)

Drug

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.

Primary outcomes

  1. Early surgical wound healing assessed by the REEDA scale

    Time frame: 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 outcomes

  1. Scar appearance assessed by the modified Stony Brook Scar Evaluation Scale (mSBSES)

    Time frame: 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.

  2. Incidence of adverse events associated with botulinum toxin type A injection

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

To Trinh Ngoc Chau, MSc

CONTACT

[email protected]

+84937262323‬

Sponsors and collaborators

Lead sponsor

Pham Ngoc Thach University of Medicine

Other

Collaborators

  • Thong Nhat Hospital

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 31, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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