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

Burn Wound and Skin Graft Healing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01242423
• Other study ID #: EA1/160/06
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 16, 2010
• Last updated: November 17, 2010
• Start date: November 2006
• Est. completion date: October 2010

Study information

• Verified date: November 2010
• Source: Unfallkrankenhaus Berlin
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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).

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®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burn Wound and Skin Graft Healing
• Burns

Intervention

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®.

Locations

Country	Name	City	State
Germany	Unfallkrankenhaus Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Unfallkrankenhaus Berlin

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The period leading up to the complete healing of the wound (reepithelization).			No
Secondary	Manifestation of undesirable local events (e.g. reddening, swelling, hematoma).			Yes