Clinical trial NCT01242423: Healing of Burns and the Effect of Shockwave Therapy on the Recovery of Skin Grafts
Official title: Accelerated Healing of Second Degree Burns and the Effect of Musculoskeletal Shockwave Therapy on the Recovery of Skin Graft Donor Sites
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Burn Wound and Skin Graft Healing
Keywords: musculoskeletal shockwave therapy
Lead sponsor: Unfallkrankenhaus Berlin
Sponsor class: OTHER
First posted: 2010-11-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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®.

Eligibility criteria: 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

Primary outcomes:
measure: The period leading up to the complete healing of the wound (reepithelization).
Secondary outcomes:
measure: Manifestation of undesirable local events (e.g. reddening, swelling, hematoma).
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Unfallkrankenhaus Berlin
Study officials:
affiliation: Unfallkrankenhaus Berlin
name: Bernd Hartmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ottomann C, Stojadinovic A, Lavin PT, Gannon FH, Heggeness MH, Thiele R, Schaden W, Hartmann B. Prospective randomized phase II Trial of accelerated reepithelialization of superficial second-degree burn wounds using extracorporeal shock wave therapy. Ann Surg. 2012 Jan;255(1):23-9. doi: 10.1097/SLA.0b013e318227b3c0.