Botulinum Toxin Type A for Wound Healing After Laparoscopic Colectomy

NCT07795463 | Recruiting

• 1 other identifier: 26140-BVTN
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Wound Healing; Botulinum Toxin, Type A

Keywords

Botulinum Toxin Type A; Surgical Wound; Wound Healing; Surgical Scar; Laparoscopic Colectomy

Outcome Measures

Primary Outcomes (1)

• 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.

  Postoperative days 0, 7, and 14

Secondary Outcomes (2)

• 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

Study Arms (2)

Botulinum Toxin Type A Group

EXPERIMENTAL

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)

Control Group

NO INTERVENTION

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.

Interventions

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.

Botulinum Toxin Type A Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older.
• Vietnamese nationality.
• Indication for laparoscopic colectomy.
• Willing and able to provide written informed consent to participate in the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pham Ngoc Thach University of Medicine: lead
• Thong Nhat Hospital: collaborator

Study Sites (1)

Thong Nhat hospital

Ho Chi Minh City, Vietnam

RECRUITING

MeSH Terms

Conditions

Surgical Wound

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Central Study Contacts

To Trinh Ngoc Chau, MSc

CONTACT

+84937262323‬; bstrinh86@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: August 31, 2026
• Study Start: August 10, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: August 31, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)