Unfallkrankenhaus Berlin
Berlin, State of Berlin, Germany
NCT Number: NCT01242423
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).
Looking for future studies?
Notify Me18 year–80 year
All sexes
Interventional
Phase 2 / Phase 3
Berlin, State of Berlin, Germany
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®.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Anamnestic exclusion criteria
Local exclusion criteria
Excluded from the study are those with burns in the regions:
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
Unfallkrankenhaus Berlin
Other
Accelerated Healing of Second Degree Burns and the Effect of Musculoskeletal Shockwave Therapy on the Recovery of Skin Graft Donor Sites
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04685577
Burn Degree Second, Burn; Multiple Body Regions, Max. Second Degree
Edmonton, Alberta, Canada
View Trial DetailsNCT01749371
Burn, Burns
Dallas, Texas, United States
View Trial DetailsNCT07183943
Burns, Wounds and Injuries
Cairo, Egypt
View Trial DetailsNCT07255937
Arterial Leg Ulcer, Burns
Madrid, Spain
View Trial Details