Perioperative Management of DIEP Flaps

Mammaplasty Clinical Trial

Official title:

Perioperative Management of Deep Inferior Epgastric Perforator (DIEP) Flap for Breast Reconstruction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03118024
• Other study ID #: 16-101-0293
• Status: Recruiting
• Phase: N/A
• First received: March 25, 2017
• Last updated: April 12, 2017
• Start date: March 13, 2017
• Est. completion date: March 2019

Study information

• Verified date: April 2017
• Source: University of Regensburg
• Contact: Alexandra Anker, MD
• Phone: 0049 941 782 3110
• Email: aanker[@]caritasstjosef.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

By comparison of two different protocols with diverse fluid/ catecholamine administration limits (fluid restriction vs. catecholamine restriction with target systolic blood pressure > 100 mmHg) the investigators would like to reveal the impact of intraoperative blood pressure management on the survival rate of free deep inferior epigastric artery flaps for breast reconstruction.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion criteria:

• Informed consent for study participation

• Every patient undergoing breast reconstruction (primary and secondary reconstruction) with deep inferior epigastric perforator flap at our hospital is offered to participate in the study

Exclusion criteria:

• No informed consent for study participation

• Patients with a high thromboembolic risk profile

• During pregnancy and breastfeeding

• Minors

• Patients with a health care proxy

Related Conditions & MeSH terms

• Free Tissue Flaps
• Mammaplasty
• Microsurgery

Intervention

Drug:
• Crystalloid Solutions
crystalloid restrictive anesthesia protocol
• Catecholamines
catecholamine restrictive anesthesia protocol

Locations

Country	Name	City	State
Germany	University hospital of Regensburg	Regensburg

Sponsors (1)

Lead Sponsor	Collaborator
University of Regensburg

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Eley KA, Young JD, Watt-Smith SR. Epinephrine, norepinephrine, dobutamine, and dopexamine effects on free flap skin blood flow. Plast Reconstr Surg. 2012 Sep;130(3):564-70. doi: 10.1097/PRS.0b013e31825dbf73. — View Citation

Motakef S, Mountziaris PM, Ismail IK, Agag RL, Patel A. Emerging paradigms in perioperative management for microsurgical free tissue transfer: review of the literature and evidence-based guidelines. Plast Reconstr Surg. 2015 Jan;135(1):290-9. doi: 10.1097/PRS.0000000000000839. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Free flap survival rate	Rates of (partial) flap loss in each study arm	5 days postoperatively
Secondary	Period of hospitalization	Length of postoperative hospitalization in each study arm	up to 14 days