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

Unfallkrankenhaus Berlin

Status and phase: Completed; Phase 3; Phase 2

Conditions: Burn Wound and Skin Graft Healing

Treatments: Device: extracorporeal shockwave therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01242423

EA1/160/06

Details and patient eligibility

About

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).

Full 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®.

Enrollment: 100 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

1. pregnancy
2. below 18 or above 80 years of age
3. burns requiring artificial respiration, since consent for the study participation is unobtainable
4. extent of burns ≤1% to ≥30% of the body surface

Anamnestic exclusion criteria

1. diabetes mellitus requiring insulin
2. dialysis-dependent
3. ongoing chemotherapy treatment
4. drug abuse
5. systemic skin diseases
6. systemic and local cortisone therapy

Local exclusion criteria

Excluded from the study are those with burns in the regions:

1. head, face, neck
2. proximal ventral and dorsal thorax

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

superficial 2nd degree burn

Experimental group

Description:

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.

Treatment:

Device: extracorporeal shockwave therapy

deep 2nd degree burn

Experimental group

Description:

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.

Treatment:

Device: extracorporeal shockwave therapy

skin excision for the purpose of a skin graft

Experimental group

Description:

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.

Treatment:

Device: extracorporeal shockwave therapy