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

Primary Purpose

Burn Wound and Skin Graft Healing

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
extracorporeal shockwave therapy
Sponsored by
Unfallkrankenhaus Berlin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burn Wound and Skin Graft Healing focused on measuring musculoskeletal shockwave therapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Unfallkrankenhaus Berlin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

superficial 2nd degree burn

deep 2nd degree burn

skin excision for the purpose of a skin graft

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 16, 2010
Last Updated
November 17, 2010
Sponsor
Unfallkrankenhaus Berlin
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1. Study Identification

Unique Protocol Identification Number
NCT01242423
Brief Title
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

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Unfallkrankenhaus Berlin

4. Oversight

Data Monitoring Committee
No

5. Study Description

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®.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn Wound and Skin Graft Healing
Keywords
musculoskeletal shockwave therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
superficial 2nd degree burn
Arm Type
Experimental
Arm Description
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.
Arm Title
deep 2nd degree burn
Arm Type
Experimental
Arm Description
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.
Arm Title
skin excision for the purpose of a skin graft
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
extracorporeal shockwave therapy
Other Intervention Name(s)
ESWT
Intervention 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®.
Primary Outcome Measure Information:
Title
The period leading up to the complete healing of the wound (reepithelization).
Secondary Outcome Measure Information:
Title
Manifestation of undesirable local events (e.g. reddening, swelling, hematoma).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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 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 Anamnestic exclusion criteria diabetes mellitus requiring insulin dialysis-dependent ongoing chemotherapy treatment drug abuse systemic skin diseases systemic and local cortisone therapy Local exclusion criteria Excluded from the study are those with burns in the regions: head, face, neck proximal ventral and dorsal thorax
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernd Hartmann, MD
Organizational Affiliation
Unfallkrankenhaus Berlin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unfallkrankenhaus Berlin
City
Berlin
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
21775883
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.
Results Reference
derived

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

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