Flap Preconditioning by Intermittent Negative Pressure

NCT ID: NCT03900065

Last Updated: 2019-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-07-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Complication of Surgical Procedure Flap Ischemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized control trial comparing no preconditioning to preconditioning.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control group

No preconditioning of the flap.

Group Type NO_INTERVENTION

No interventions assigned to this group

Preconditioned group

Preconditioning of the flap prior to surgery.

Group Type EXPERIMENTAL

Preconditioning

Intervention Type PROCEDURE

Foam-mediated intermittent negative pressure will be applied to the skin of the planned flap for 5 days before surgery.

Interventions

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Preconditioning

Foam-mediated intermittent negative pressure will be applied to the skin of the planned flap for 5 days before surgery.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruhr University of Bochum

OTHER

Sponsor Role lead

Responsible Party

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Mehran Dadras, MD

Chief resident, Department of Plastic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Björn Behr, MD

Role: PRINCIPAL_INVESTIGATOR

Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil Bochum

Mehran Dadras, MD

Role: STUDY_DIRECTOR

Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil Bochum

Locations

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Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil

Bochum, North Rhine-Westphalia, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Mehran Dadras, MD

Role: CONTACT

+492343023560

Björn Behr, MD

Role: CONTACT

+492343023443

Facility Contacts

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Mehran Dadras, MD

Role: primary

+492343023560

Björn Behr, MD

Role: backup

+492343023443

Other Identifiers

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18-6408-BR

Identifier Type: -

Identifier Source: org_study_id

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