Botulinum toxin injection to reduce scarring after unilateral cleft lip repair
Efficacy of Botulinum Toxin Injection in Reducing Scar Following Cheilorrhaphy: A Randomized Controlled Clinical Trial.
This will test whether injecting botulinum toxin A before surgical repair reduces scarring in people with unilateral cleft lip.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 10 Weeks and up |
| Sex | All |
| Sponsor | Mansoura University Academic / other |
| Locations | 1 site (Al Mansurah) |
| Trial ID | NCT07137234 on ClinicalTrials.gov |
What this trial studies
This interventional study gives a botulinum toxin A injection before performing a modified Millard rotation-advancement repair to see if reducing muscle tension around the lip improves scar appearance. Eligible participants are non-syndromic patients with mild to severe unilateral cleft lip, with or without cleft palate, who are fit for general anesthesia; patients with syndromic clefts or systemic disease are excluded. Outcomes will be measured by standardized clinical and photographic scar assessments during postoperative follow-up. The single-center trial is conducted at Mansoura University in Al Mansurah, Egypt.
Who should consider this trial
Good fit: Ideal candidates are non-syndromic patients with mild to severe unilateral cleft lip (with or without cleft palate) who are fit for general anesthesia and surgery.
Not a fit: Patients with syndromic cleft lip, significant systemic disease, or those unable to travel to the single study center are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, the approach could produce less visible scarring and improved cosmetic outcomes after cleft lip repair.
How similar studies have performed: Small surgical series and facial wound studies have suggested botulinum toxin A can reduce scar tension and improve cosmetic outcomes, but its use specifically for cleft lip repair remains relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
inclusion criteria : * patients with mild to severe unilateral cleft lip requiring repair * free from any systemic disease * with or without cleft palate * fit for general anesthesia exclusion criteria : * patients with syndromic type of cleft lip * patients with systemic disease
Where this trial is running
Al Mansurah
- Mansoura University — Al Mansurah, Egypt (Recruiting)
Study contacts
- Principal investigator: Basel Saeed Shamaa, Master's — Mansoura University
- Study coordinator: Basel Saeed Shamaa, Master's
- Email: baselshamaa@mans.edu.eg
- Phone: +201067705286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.