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BEMER - Physical vascular therapy to improve the micro circulation and tissue regeneration after microsurgical flap reconstruction

BEMER - Physical vascular therapy to improve the micro circulation and tissue regeneration after microsurgical flap reconstruction

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00033624
Enrollment
40
Registered
2024-03-04
Start date
2025-01-31
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with a fasciocutaneous, musculo-fasciocutaneouss or osseo-fasciocutaneouss transplant

Interventions

Group 1: Arm A: Physical vascular therapy local (belt): The participants receive the belt B.PAD EVO for the local, post-operative application of the pulsed electro-magentic field at the donor site of

Sponsors

BEMER INT. AG
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Fasciocutaneouss, musculo-fasciocutaneous or osseo-fasciocutaneous transplant Informed Consent

Exclusion criteria

Exclusion criteria: Incapability of the patient in giving an informed consent Dementi or marked cognitive dysfunction Terminal disease with a life expectancy < 12 months Condition after organ transplantation Simultaneous participation in a pharmacological study Pregnancy Implanted insulin pump Implanted pace maker Active Hepatitis B or C infection

Design outcomes

Primary

MeasureTime frame
Wound healing (appearance, micro-circulatory characterization (parameters inter alia tissue oxygen saturation)) in the vicinity of the transplant donor site.

Secondary

MeasureTime frame
Improvement of quality of life e.g. by decrease of (wound) pain (assessment via the SF-12 questionnaire at the visits V0, V1 and V10)

Countries

Germany

Contacts

Public ContactRalph Smeets

Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Mund-, Kiefer- und Gesichtschirurgie

r.smeets@uke.de+49 40/7410-53254

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026