search
Back to results

Flap Preconditioning by Intermittent Negative Pressure

Primary Purpose

Complication of Surgical Procedure, Flap Ischemia

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Preconditioning
Sponsored by
Ruhr University of Bochum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complication of Surgical Procedure focused on measuring flap preconditioning

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Berufsgenossenschaftliches Universitätsklinikum BergmannsheilRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Preconditioned group

Arm Description

No preconditioning of the flap.

Preconditioning of the flap prior to surgery.

Outcomes

Primary Outcome Measures

Percentage of hypoperfused skin island
The percentage of hypoperfused skin island should be measured clinically after surgery
Skin oxygen saturation of distal flap
The skin oxygen saturation of distal flap is measured via laserdoppler

Secondary Outcome Measures

Wound complications
wound complications including need of surgical reoperation are assessed
VEGF expression in skin and muscle of flap
Laboratory examination of tissue specimen obtained during surgery
Density of flap dermal vessels
Laboratory examination of tissue specimen obtained during surgery

Full Information

First Posted
March 26, 2019
Last Updated
April 1, 2019
Sponsor
Ruhr University of Bochum
search

1. Study Identification

Unique Protocol Identification Number
NCT03900065
Brief Title
Flap Preconditioning by Intermittent Negative Pressure
Official Title
Lappenpräkonditionierung Durch Intermittierende Negative Drucktherapie - Eine Prospektive, Randomisierte, Kontrollierte Klinische Studie
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
June 1, 2020 (Anticipated)
Study Completion Date
July 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruhr University of Bochum

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complication of Surgical Procedure, Flap Ischemia
Keywords
flap preconditioning

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized control trial comparing no preconditioning to preconditioning.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
No preconditioning of the flap.
Arm Title
Preconditioned group
Arm Type
Experimental
Arm Description
Preconditioning of the flap prior to surgery.
Intervention Type
Procedure
Intervention Name(s)
Preconditioning
Intervention Description
Foam-mediated intermittent negative pressure will be applied to the skin of the planned flap for 5 days before surgery.
Primary Outcome Measure Information:
Title
Percentage of hypoperfused skin island
Description
The percentage of hypoperfused skin island should be measured clinically after surgery
Time Frame
up to 7 days postoperatively
Title
Skin oxygen saturation of distal flap
Description
The skin oxygen saturation of distal flap is measured via laserdoppler
Time Frame
1 day postoperative
Secondary Outcome Measure Information:
Title
Wound complications
Description
wound complications including need of surgical reoperation are assessed
Time Frame
up to 12 weeks postoperatively
Title
VEGF expression in skin and muscle of flap
Description
Laboratory examination of tissue specimen obtained during surgery
Time Frame
once during surgery
Title
Density of flap dermal vessels
Description
Laboratory examination of tissue specimen obtained during surgery
Time Frame
once during surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mehran Dadras, MD
Phone
+492343023560
Email
mehran.dadras@bergmannsheil.de
First Name & Middle Initial & Last Name or Official Title & Degree
Björn Behr, MD
Phone
+492343023443
Email
bjorn.behr@rub.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Björn Behr, MD
Organizational Affiliation
Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil Bochum
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mehran Dadras, MD
Organizational Affiliation
Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil Bochum
Official's Role
Study Director
Facility Information:
Facility Name
Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil
City
Bochum
State/Province
NRW
ZIP/Postal Code
44789
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mehran Dadras, MD
Phone
+492343023560
Email
mehran.dadras@bergmannsheil.de
First Name & Middle Initial & Last Name & Degree
Björn Behr, MD
Phone
+492343023443
Email
bjorn.behr@rub.de

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Flap Preconditioning by Intermittent Negative Pressure

We'll reach out to this number within 24 hrs