NCT06913257 Cost-Effectiveness of ESWT Plus Rehabilitation vs Rehabilitation Alone in Post-Burn Scars
| NCT ID | NCT06913257 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Al Hayah University In Cairo |
| Condition | Hypertrophic Scar |
| Study Type | INTERVENTIONAL |
| Enrollment | 104 participants |
| Start Date | 2025-04-22 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 104 participants in total. It began in 2025-04-22 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This randomized controlled trial (RCT) will evaluate the cost-effectiveness of combining extracorporeal shock wave therapy (ESWT) with standard rehabilitation versus standard rehabilitation alone for the management of hypertrophic post-burn scars in adults. The study will assess clinical outcomes-such as pain intensity, pruritus, and scar quality-alongside economic outcomes including cost per quality-adjusted life year (QALY) gained, direct medical costs, and indirect costs (e.g., absenteeism and reduced productivity). Results will inform health policy and resource allocation decisions for advanced burn rehabilitation interventions.
Eligibility Criteria
Inclusion Criteria: Adults aged 18-65 years. Documented hypertrophic scars following a burn injury, with scars present and stable for at least 6 months. Moderate to severe scar severity as measured by a standardized clinical assessment. Experiencing significant pain and/or pruritus related to the scar, with a baseline VAS score of ≥4. Able to provide informed consent and comply with study procedures. Employed or engaged in daily activities such that indirect costs (absenteeism/reduced productivity) can be recorded. Exclusion Criteria: Pregnant or lactating women. Individuals with previous surgical scar revision or other invasive scar treatments within the last 6 months. Patients with comorbid conditions (e.g., severe cardiovascular disease, uncontrolled diabetes) that could interfere with rehabilitation or ESWT. Active skin infection in the area of the scar. Use of concurrent investigational therapies for scar management.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06913257 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Hypertrophic Scar. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06913257 currently recruiting?
Yes, NCT06913257 is actively recruiting participants. Contact the research team at ibrahim.alzoheiry@hotmail.com for enrollment information.
Where is the NCT06913257 trial being conducted?
This trial is being conducted at Cairo, Egypt.
Who is sponsoring the NCT06913257 clinical trial?
NCT06913257 is sponsored by Al Hayah University In Cairo. The trial plans to enroll 104 participants.