Flap Preconditioning by Intermittent Negative Pressure

NCT03900065 | Unknown

• 1 other identifier: 18-6408-BR
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Complication of Surgical Procedure; Flap Ischemia

Keywords

flap preconditioning

Outcome Measures

Primary Outcomes (2)

• Percentage of hypoperfused skin island

  The percentage of hypoperfused skin island should be measured clinically after surgery

  up to 7 days postoperatively

• Skin oxygen saturation of distal flap

  The skin oxygen saturation of distal flap is measured via laserdoppler

  1 day postoperative

Secondary Outcomes (3)

• Wound complications

  up to 12 weeks postoperatively

• VEGF expression in skin and muscle of flap

  once during surgery

• Density of flap dermal vessels

  once during surgery

Study Arms (2)

Control group

NO INTERVENTION

No preconditioning of the flap.

Preconditioned group

EXPERIMENTAL

Preconditioning of the flap prior to surgery.

Procedure: Preconditioning

Interventions

Preconditioning PROCEDURE

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

Preconditioned group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients receiving a free or pedicled musculocutaneous M. latissimus dorsi-flap with the time frame of 5 days preconditioning.

You may not qualify if:

• Infection of skin of planned flap.

Sponsors & Collaborators

• Ruhr University of Bochum: lead

Study Sites (1)

Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil

Bochum, North Rhine-Westphalia, 44789, Germany

RECRUITING

Study Officials

• Björn Behr, MD

  Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil Bochum

  PRINCIPAL INVESTIGATOR

• Mehran Dadras, MD

  Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil Bochum

  STUDY DIRECTOR

Central Study Contacts

Mehran Dadras, MD

CONTACT

+492343023560; mehran.dadras@bergmannsheil.de

Björn Behr, MD

CONTACT

+492343023443; bjorn.behr@rub.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief resident, Department of Plastic Surgery

Model Details: Randomized control trial comparing no preconditioning to preconditioning.

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: April 2, 2019
• Study Start: January 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: July 1, 2020
• Last Updated: April 2, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)