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

Last updated: November 17, 2010
Sponsor: Unfallkrankenhaus Berlin
Overall Status: Completed

Phase

2/3

Condition

Skin Wounds

Hyponatremia

Treatment

N/A

Clinical Study ID

NCT01242423
EA1/160/06
  • Ages 18-80
  • All Genders

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).

Eligibility Criteria

Inclusion

Inclusion Criteria: Group A (n=50): Consent-capable male and female patients between ≥18 and ≤80 years of agewho have sustained a superficial 2nd degree burn on ≥1% and ≤30% of the surface of thebody. Group B (n=50): Consent-capable male and female patients between ≥18 and ≤80 years of agewho 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 agewho require a skin excision for the purpose of a skin graft. The minimal size of theskin-graft donor site must not be less than 1% of BBS.

Exclusion

Exclusion Criteria: General exclusion criteria

  1. pregnancy

  2. below 18 or above 80 years of age

  3. burns requiring artificial respiration, since consent for the study participation isunobtainable

  4. extent of burns ≤1% to ≥30% of the body surface Anamnestic exclusion criteria

  5. diabetes mellitus requiring insulin

  6. dialysis-dependent

  7. ongoing chemotherapy treatment

  8. drug abuse

  9. systemic skin diseases

  10. systemic and local cortisone therapy Local exclusion criteria Excluded from the study are those with burns in the regions:

  11. head, face, neck

  12. proximal ventral and dorsal thorax

Study Design

Total Participants: 100
Study Start date:
November 01, 2006
Estimated Completion Date:
October 31, 2010

Study 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®.

Connect with a study center

  • Unfallkrankenhaus Berlin

    Berlin,
    Germany

    Site Not Available

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