Flap Preconditioning by Intermittent Negative Pressure

Complication of Surgical Procedure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03900065
• Other study ID #: 18-6408-BR
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: July 1, 2020

Study information

• Verified date: March 2019
• Source: Ruhr University of Bochum
• Contact: Mehran Dadras, MD
• Phone: +492343023560
• Email: mehran.dadras[@]bergmannsheil.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: July 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Complication of Surgical Procedure
• Flap Ischemia
• Ischemia

Intervention

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

Locations

Country	Name	City	State
Germany	Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil	Bochum	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Ruhr University of Bochum

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of hypoperfused skin island	The percentage of hypoperfused skin island should be measured clinically after surgery	up to 7 days postoperatively
Primary	Skin oxygen saturation of distal flap	The skin oxygen saturation of distal flap is measured via laserdoppler	1 day postoperative
Secondary	Wound complications	wound complications including need of surgical reoperation are assessed	up to 12 weeks postoperatively
Secondary	VEGF expression in skin and muscle of flap	Laboratory examination of tissue specimen obtained during surgery	once during surgery
Secondary	Density of flap dermal vessels	Laboratory examination of tissue specimen obtained during surgery	once during surgery