Flap Preconditioning by Intermittent Negative Pressure

Not Applicable

• Conditions: Complication of Surgical Procedure; Flap Ischemia
• Interventions: Procedure: Preconditioning

• Registration Number: NCT03900065
• Lead Sponsor: Ruhr University of Bochum

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2019-01-01
• Status Verified: 2019-03
• Study First Submitted: 2019-03-26
• Study First Submitted QC: 2019-04-01
• Last Update Submitted: 2019-04-01
• Study First Posted: 2019-04-02
• Last Update Posted: 2019-04-02
• Primary Completion: 2020-06-01
• Study Completion: 2020-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preconditioned group	Preconditioning	Preconditioning of the flap prior to surgery.

Primary Outcome Measures

Name	Time	Method
Percentage of hypoperfused skin island	up to 7 days postoperatively	The percentage of hypoperfused skin island should be measured clinically after surgery
Skin oxygen saturation of distal flap	1 day postoperative	The skin oxygen saturation of distal flap is measured via laserdoppler

Secondary Outcome Measures

Name	Time	Method
Wound complications	up to 12 weeks postoperatively	wound complications including need of surgical reoperation are assessed
VEGF expression in skin and muscle of flap	once during surgery	Laboratory examination of tissue specimen obtained during surgery
Density of flap dermal vessels	once during surgery	Laboratory examination of tissue specimen obtained during surgery

Trial Locations

Locations (1)

Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil; 🇩🇪 Bochum, NRW, Germany