Flap Preconditioning by Intermittent Negative Pressure

April 1, 2019 updated by: Mehran Dadras, MD, Ruhr University of Bochum

Lappenpräkonditionierung Durch Intermittierende Negative Drucktherapie - Eine Prospektive, Randomisierte, Kontrollierte Klinische Studie

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Bochum, NRW, Germany, 44789
        • Recruiting
        • Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
No preconditioning of the flap.
Experimental: Preconditioned group
Preconditioning of the flap prior to surgery.
Procedure: Preconditioning
Foam-mediated intermittent negative pressure will be applied to the skin of the planned flap for 5 days before surgery.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruhr University of Bochum

Investigators

  • Principal Investigator: Björn Behr, MD, Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil Bochum
  • Study Director: Mehran Dadras, MD, Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil Bochum

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Anticipated)

June 1, 2020

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

March 26, 2019

First Submitted That Met QC Criteria

April 1, 2019

First Posted (Actual)

April 2, 2019

Study Record Updates

Last Update Posted (Actual)

April 2, 2019

Last Update Submitted That Met QC Criteria

April 1, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-6408-BR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Complication of Surgical Procedure

Clinical Trials on Preconditioning

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Poland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe