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Completed

NCT Number: NCT01242423

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

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).

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Unfallkrankenhaus Berlin

Berlin, State of Berlin, Germany

About this study

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®.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

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

Treatment and study plan

Extracorporeal shockwave therapy

Device

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®.

Other names: ESWT

Primary outcomes

  1. The period leading up to the complete healing of the wound (reepithelization).

Secondary outcomes

  1. Manifestation of undesirable local events (e.g. reddening, swelling, hematoma).

Sponsors and collaborators

Lead sponsor

Unfallkrankenhaus Berlin

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Nov 17, 2010
Registry last updated
Nov 18, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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