NCT01242423

Healing of Burns and the Effect of Shockwave Therapy on the Recovery of Skin Grafts

Accelerated Healing of Second Degree Burns and the Effect of Musculoskeletal Shockwave Therapy on the Recovery of Skin Graft Donor Sites

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Unfallkrankenhaus Berlin · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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®.

Conditions

• Burn Wound and Skin Graft Healing

Interventions

Type	Name	Description
DEVICE	extracorporeal shockwave therapy	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®.

Timeline

• Start date: 2006-11-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2010-11-17
• Last updated: 2010-11-18

Locations

1 site across 1 country: Germany