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

This study has been completed.
Sponsor:
Information provided by:
Unfallkrankenhaus Berlin
ClinicalTrials.gov Identifier:
NCT01242423
First received: November 16, 2010
Last updated: November 17, 2010
Last verified: November 2010
  Purpose

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).


Condition Intervention Phase
Burn Wound and Skin Graft Healing
Device: extracorporeal shockwave therapy
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Accelerated Healing of Second Degree Burns and the Effect of Musculoskeletal Shockwave Therapy on the Recovery of Skin Graft Donor Sites

Resource links provided by NLM:


Further study details as provided by Unfallkrankenhaus Berlin:

Primary Outcome Measures:
  • The period leading up to the complete healing of the wound (reepithelization). [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Manifestation of undesirable local events (e.g. reddening, swelling, hematoma). [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: November 2006
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: ESWT

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01242423

Locations
Germany
Unfallkrankenhaus Berlin
Berlin, Germany
Sponsors and Collaborators
Unfallkrankenhaus Berlin
Investigators
Principal Investigator: Bernd Hartmann, MD Unfallkrankenhaus Berlin
  More Information

No publications provided by Unfallkrankenhaus Berlin

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christian Ottoman, Unfallkrankenhaus Berlin
ClinicalTrials.gov Identifier: NCT01242423     History of Changes
Other Study ID Numbers: EA1/160/06
Study First Received: November 16, 2010
Last Updated: November 17, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by Unfallkrankenhaus Berlin:
musculoskeletal shockwave therapy

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on August 28, 2014