Flap Preconditioning by Intermittent Negative Pressure

Ruhr University of Bochum

Status: Unknown

Conditions: Complication of Surgical Procedure; Flap Ischemia

Treatments: Procedure: Preconditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT03900065

18-6408-BR

Details and patient eligibility

About

A randomized controlled trial to investigate the effect of negative pressure preconditioning of flaps on surgical outcome and microcirculation of the tissue.

Full description

Flap surgery relies on the perfusion of the transposed or transplanted tissue. Distal parts of flaps are at risk of ischemia leading to wound complications and reoperation. The potential benefit of a preconditioning protocol using foam mediated negative pressure on the flap before surgery is to be examined.

Enrollment: 32 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients receiving a free or pedicled musculocutaneous M. latissimus dorsi-flap with the time frame of 5 days preconditioning.

Exclusion criteria

• Infection of skin of planned flap.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

32 participants in 2 patient groups

Control group

No Intervention group

Description:

No preconditioning of the flap.

Preconditioned group

Experimental group

Description:

Preconditioning of the flap prior to surgery.

Treatment:

Procedure: Preconditioning