Flap Preconditioning by Intermittent Negative Pressure

Sponsor

Ruhr University of Bochum (Other)

Overall Status

Unknown status

CT.gov ID

NCT03900065

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Complication of Surgical Procedure Flap Ischemia	Procedure: Preconditioning	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized control trial comparing no preconditioning to preconditioning.Randomized control trial comparing no preconditioning to preconditioning.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2019

Anticipated Primary Completion Date :

Jun 1, 2020

Anticipated Study Completion Date :

Jul 1, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil	Bochum	NRW	Germany	44789

Sponsors and Collaborators

Ruhr University of Bochum

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mehran Dadras, MD, Chief resident, Department of Plastic Surgery, Ruhr University of Bochum

ClinicalTrials.gov Identifier:

NCT03900065

Other Study ID Numbers:

18-6408-BR

First Posted:

Apr 2, 2019

Last Update Posted:

Apr 2, 2019

Last Verified:

Mar 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mehran Dadras, MD, Chief resident, Department of Plastic Surgery, Ruhr University of Bochum

flap preconditioning

Additional relevant MeSH terms:

Ischemia

Study Results

No Results Posted as of Apr 2, 2019