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

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

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).

Study Overview

• Status: Completed
• Conditions: Burn Wound and Skin Graft Healing
• Intervention / Treatment: Device: extracorporeal shockwave therapy

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®.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Unfallkrankenhaus Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: superficial 2nd degree burn; 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.	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®.; Other Names: ESWT
Experimental: deep 2nd degree burn; 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.	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®.; Other Names: ESWT
Experimental: skin excision for the purpose of a skin graft; 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.	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®.; Other Names: ESWT

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Unfallkrankenhaus Berlin
• Investigators: Principal Investigator: Bernd Hartmann, MD, Unfallkrankenhaus Berlin

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: November 16, 2010
• First Submitted That Met QC Criteria: November 16, 2010
• First Posted (Estimate): November 17, 2010

Study Record Updates

• Last Update Posted (Estimate): November 18, 2010
• Last Update Submitted That Met QC Criteria: November 17, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Keywords: musculoskeletal shockwave therapy
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: EA1/160/06