Surgical Wound HealingNCT07795463
Botulinum Toxin Type A for Wound Healing After Laparoscopic Colectomy
A study testing Botulinum toxin type A (Botox®, Allergan) in people with Surgical Wound Healing and Botulinum Toxin, Type A, run by Pham Ngoc Thach University of Medicine at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Wound Healing, Botulinum Toxin, Type A
- What is being tested?
- Botulinum toxin type A (Botox®, Allergan)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteVietnam
- Study dates
- 10 Aug 2026to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older.
- Vietnamese nationality.
- Indication for laparoscopic colectomy.
- Willing and able to provide written informed consent to participate in the study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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.
Read the 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.
- Conditions
- Surgical Wound Healing, Botulinum Toxin, Type A
- Being tested
- Botulinum toxin type A (Botox®, Allergan)
- Keywords
- Botulinum Toxin Type A, Surgical Wound, Wound Healing, Surgical Scar, Laparoscopic Colectomy
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative days 0, 7, and 14
Secondary outcomes (2)
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.
Measured: 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.
Measured: From the time of BTX-A administration through postoperative day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start10 Aug 2026
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Wound HealingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pham Ngoc Thach University of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Thong Nhat Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07795463
- Sponsor's protocol ID
- 26140-BVTN
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07795463
- Acronym / sponsor ID
- 26140-BVTN
- Conditions
- Surgical Wound Healing, Botulinum Toxin, Type A
- Keywords
- Botulinum Toxin Type A, Surgical Wound, Wound Healing, Surgical Scar, Laparoscopic Colectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Pham Ngoc Thach University of MedicineUniversity, hospital or other
- Collaborators
- Thong Nhat Hospital
- Study start
- 10 Aug 2026 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 31 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Botulinum Toxin Type A Group | Experimental | Drug: Botulinum toxin type A (Botox®, Allergan)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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older.
- Vietnamese nationality.
- Indication for laparoscopic colectomy.
- Willing and able to provide written informed consent to participate in the study.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin type A (Botox®, Allergan)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. | Drug | Botulinum Toxin Type A Group |
Primary outcome
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.
2 secondary outcomes
Scar appearance assessed by the modified Stony Brook Scar Evaluation Scale (mSBSES)
Time frame: Postoperative days 7, 14, and 30
Incidence of adverse events associated with botulinum toxin type A injection
Time frame: From the time of BTX-A administration through postoperative day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botulinum toxin type A (Botox®, Allergan) in people with Surgical Wound Healing and Botulinum Toxin, Type A, run by Pham Ngoc Thach University of Medicine at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact To Trinh Ngoc Chau, MSc (+84937262323, bstrinh86@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early surgical wound healing assessed by the REEDA scale (time frame: Postoperative days 0, 7, and 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.