Accelerated Healing of Second Degree Burns and the Effect of Musculoskeletal Shockwave Therapy on the Recovery of Skin Graft Donor Sites
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Unfallkrankenhaus Berlin
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- The period leading up to the complete healing of the wound (reepithelization).
Study Overview
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®.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
- •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
Outcomes
Primary Outcomes
The period leading up to the complete healing of the wound (reepithelization).
Secondary Outcomes
- Manifestation of undesirable local events (e.g. reddening, swelling, hematoma).