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

NCT01242423 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2010-11-18

No results posted yet for this study

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).

Conditions

  • Burn Wound and Skin Graft Healing

Interventions

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®.

Sponsors & Collaborators

  • Unfallkrankenhaus Berlin

    lead OTHER

Principal Investigators

  • Bernd Hartmann, MD · Unfallkrankenhaus Berlin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01242423 on ClinicalTrials.gov