Status:
COMPLETED
Healing of Burns and the Effect of Shockwave Therapy on the Recovery of Skin Grafts
Lead Sponsor:
Unfallkrankenhaus Berlin
Conditions:
Burn Wound and Skin Graft Healing
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief Summary
The study is to review whether musculoskeletal shockwave therapy (ESWT) can speed up the healing of second-degree burns as well as skin-graft donor sites. In both cases, the primary hypothesis is the...
Detailed Description
ESWT is administered as a one-off treatment on the wound surfaces within 24 hours of a 2nd degree burn trauma and immediately after an intraoperative skin graft excision procedure. A defocused sound h...
Eligibility Criteria
Inclusion
- Group A (n=50): Consent-capable male and female patients between ≥18 and ≤80 years of age who have sustained a superficial 2nd degree burn on ≥1% and ≤30% of the surface of the body.
- Group B (n=50): Consent-capable male and female patients between ≥18 and ≤80 years of age who have sustained a deep 2nd degree burn on ≥1% and ≤30% of the surface of the body.
- Group C (n=50): Consent-capable male and female patients between ≥18 and ≤80 years of age who require a skin excision for the purpose of a skin graft. The minimal size of the skin-graft donor site must not be less than 1% of BBS.
Exclusion
- General exclusion criteria
- pregnancy
- below 18 or above 80 years of age
- burns requiring artificial respiration, since consent for the study participation is unobtainable
- extent of burns ≤1% to ≥30% of the body surface
- Anamnestic exclusion criteria
- diabetes mellitus requiring insulin
- dialysis-dependent
- ongoing chemotherapy treatment
- drug abuse
- systemic skin diseases
- systemic and local cortisone therapy
- Local exclusion criteria
- Excluded from the study are those with burns in the regions:
- head, face, neck
- proximal ventral and dorsal thorax
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01242423
Start Date
November 1 2006
End Date
October 1 2010
Last Update
November 18 2010
Active Locations (1)
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1
Unfallkrankenhaus Berlin
Berlin, State of Berlin, Germany