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

NCT01242423 | Completed Phase 2

• 1 other identifier: EA1/160/06
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Burn Wound and Skin Graft Healing

Keywords

musculoskeletal shockwave therapy

Outcome Measures

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).

Study Arms (3)

superficial 2nd degree burn

EXPERIMENTAL

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

deep 2nd degree burn

EXPERIMENTAL

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

skin excision for the purpose of a skin graft

EXPERIMENTAL

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

Interventions

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®.

Also known as: ESWT

deep 2nd degree burn; skin excision for the purpose of a skin graft; superficial 2nd degree burn

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• diabetes mellitus requiring insulin
• dialysis-dependent
• ongoing chemotherapy treatment
• drug abuse
• systemic skin diseases
• systemic and local cortisone therapy
• Excluded from the study are those with burns in the regions:
• head, face, neck
• proximal ventral and dorsal thorax

Sponsors & Collaborators

• Unfallkrankenhaus Berlin: lead

Study Sites (1)

Unfallkrankenhaus Berlin

Berlin, State of Berlin, Germany

Location

Related Publications (1)

• 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.

  PMID: 21775883 DERIVED

MeSH Terms

Conditions

Burns

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Bernd Hartmann, MD

  Unfallkrankenhaus Berlin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 16, 2010
• First Posted: November 17, 2010
• Study Start: November 1, 2006
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: November 18, 2010

Record last verified: 2010-11

Locations

DE (1)