Comparing Botulinum Toxin-A and Shock Wave Therapy for Scars in Burned Children
Botulinum Toxin-A Injection and Shock Waves on Hypertrophic Scars in Hand-burned Children
This study is testing whether Botulinum toxin-A injections or shock wave therapy works better for improving scars and wrist movement in children aged 6 to 18 who have burned their hands.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 6 Years to 18 Years |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Giza) |
| Trial ID | NCT06174155 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of Botulinum toxin-A injections versus shock wave therapy in treating hypertrophic scars in children who have suffered hand burns. The research focuses on assessing improvements in wrist functionality and scar severity after these treatments, alongside a traditional physical therapy program. Children aged 6 to 18 with specific burn-related criteria will be included, and the study will evaluate outcomes such as wrist extension and hand grip strength. The goal is to determine if one treatment is superior to the other in enhancing recovery.
Who should consider this trial
Good fit: Ideal candidates are children aged 6-18 with hypertrophic scars from hand burns and specific functional impairments.
Not a fit: Patients with underlying medical conditions or complications that could interfere with treatment outcomes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for improving scar outcomes and functionality in children with hand burns.
How similar studies have performed: While there have been studies on scar treatments, this specific comparison of Botulinum toxin-A and shock wave therapy in children is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age will range from 6-18 years * Diagnosed with hypertrophic scars resulting from hand burns. * Has burn injuries caused by flame, scald or chemical agents. * With a total body surface area (TBSA) varied from 10 to 30% * A resistant partial or complete loss of wrist flexion attributable to wrist flexor contracture * After wound and skin graft healing (\~ 90 days post-surgery), Exclusion criteria: * Children with underlying medical conditions that could interfere with scar healing or treatment outcomes * Skin flap surgery, malignancies, cardiac arrhythmias, pacemaker implantation, coagulopathies, fractures about the treatment area, articular adhesions, and psychiatric co-morbidities
Where this trial is running
Giza
- Reham Alsakhawi — Giza, Egypt (Recruiting)
Study contacts
- Principal investigator: Reham Alsakhawi — Assistant Professor
- Study coordinator: Reham Alsakhawi
- Email: rsm211_pt@yahoo.com
- Phone: 00201015447798
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.