Healing of Burns and the Effect of Shockwave Therapy on the Recovery of Skin Grafts
- Conditions
- Burn Wound and Skin Graft Healing
- Interventions
- Device: extracorporeal shockwave therapy
- Registration Number
- NCT01242423
- Lead Sponsor
- Unfallkrankenhaus Berlin
- 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 shortened period leading up to the complete healing of the wound (reepithelization).
The secondary hypothesis in the course of the study assesses:
the rare manifestation of undesirable local events (e.g. reddening, swelling, hematoma).
- 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 head is orthogradely applied to the burn wound or the donor site. 100 impulses/cm² is administered at 20 seconds per cm². The defocused sound head is placed on the wound along with a sterile gel (Lavaseptgel®, Octenidingel®) and a sterile protection foil. The shockwaves deployed are not at an energy density that is painful. This single application of ESWT is followed by routine dressing using Mepitel® in combination with Polyhexanid/Octenidin®.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
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.
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description superficial 2nd degree burn extracorporeal shockwave therapy 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. deep 2nd degree burn extracorporeal shockwave therapy 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. skin excision for the purpose of a skin graft extracorporeal shockwave therapy 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.
- Primary Outcome Measures
Name Time Method The period leading up to the complete healing of the wound (reepithelization).
- Secondary Outcome Measures
Name Time Method Manifestation of undesirable local events (e.g. reddening, swelling, hematoma).
Trial Locations
- Locations (1)
Unfallkrankenhaus Berlin
🇩🇪Berlin, Germany