Botulinum Toxin Type A for Wound Healing After Laparoscopic Colectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPham Ngoc Thach University of Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older.
Vietnamese nationality.
Indication for laparoscopic colectomy.
Willing and able to provide written informed consent to participate in the study.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Botulinum toxin type A (Botox®, Allergan)
DrugBotulinum 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Botulinum Toxin Type A GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
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.
Time frame
Postoperative days 0, 7, and 14Secondary outcomes
1
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 302
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 30Sponsors and contacts
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Pham Ngoc Thach University of Medicine
Lead sponsor
Thong Nhat Hospital
Collaborator
Source ClinicalTrials.gov