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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02759796
Other study ID # idipaz
Secondary ID
Status Completed
Phase N/A
First received April 5, 2016
Last updated April 21, 2017
Start date November 2015
Est. completion date April 2017

Study information

Verified date April 2017
Source Instituto de Investigación Hospital Universitario La Paz
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

It is a single-center, prospective, randomized and controlled study focused in microsurgical autologous breast reconstruction. It involves applying indocyanine green (ICG) angiography for the study of the vascularization of DIEP flaps. The aim of the study is to determine whether there are differences in complications and aesthetic results when ICG is used to discard the poorly vascularized areas of the flap. The study includes adult women undergoing unilateral DIEP flap breast reconstruction. The calculated sample size is 60 patients. There are two groups. In group 1, the investigators use the usual clinical criteria to discard the poorly vascularized areas of the flap. In group 2, the investigators use the ICG to shape the flap.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date April 2017
Est. primary completion date April 2017
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Mastectomized adult female patient

- Abdominal flap unilateral breast reconstruction indication

- Alloplastic breast reconstruction sequelae

- Enough amount of abdominal dermofat tissue to shape a breast with a primary closure of the donor site

Exclusion Criteria:

- DIEP flap bilateral breast reconstruction indication

- Previous abdominoplasty surgery

- Untreated psychiatric disease

- Untreated infection

- Indocyanine green or iodine hypersensitivity

- Hyperthyroidism, thyroid adenoma or thyroid autonomy

- Any concomitant disease or condition that, in the opinion of the investigator, can make the patient unsuitable to receive a microsurgical technique or to join the research.

Study Design


Intervention

Procedure:
Tailoring the flap according to clinical assessment
After microvascular anastomosis is performed, the investigators clinically assess flap vascularization and the well vascularized tissue is marked by means of a dermographic pencil. Then the investigators administer 0,2mg/kg of ICG intravenously. The vascularization of the flap is also checked by means of the Photo Dynamic Eye (Pulsion Medical System) but finally the decision of discarding the poorly vascularized areas of the flap is made by clinical assessment.
Tailoring the flap according to ICG Angiography assessment
After microvascular anastomosis is performed, the investigators administer 0,2mg/kg of ICG intravenously. Then the investigators check the vascularization of the flap by means of the Photo Dynamic Eye (Pulsion Medical System) and the poorly vascularized areas of the flap are discarded guided by ICG perfusion test.

Locations

Country Name City State
Spain La Paz University Hospital Madrid

Sponsors (1)

Lead Sponsor Collaborator
Instituto de Investigación Hospital Universitario La Paz

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with fat necrosis as assessed by physical examination Six months postoperatively
Primary Number of participants with fat necrosis as assessed by ultrasonography Six months postoperatively
Secondary Number of participants with flap failure as assessed by physical examination From intraoperative moment to one week postoperatively
Secondary Number of participants with wound infection as assessed by physical examination From one day postoperatively to two weeks postoperatively
Secondary Number of participants with wound healing delay as assessed by physical examination From two weeks postoperatively to two months postoperatively
Secondary Number of participants with reoperation From immediate postoperative moment to one year postoperatively
Secondary Flap perfusion index as assessed by IC-CALC software (Pulsion Medical System) Intraoperatively
Secondary Flap weight (grams) Intraoperatively
Secondary Flap length (centimeters) Intraoperatively
Secondary Breast-Q questionnaire (preoperative reconstruction module) to measure patient preoperative status A preoperative test in the last week before surgery
Secondary Breast-Q questionnaire (postoperative reconstruction module) to measure patient postoperative status A postoperative test one year after surgery
Secondary ICG security (Number of participants with tachycardia, exanthema and anaphylactic shock as assessed by physical examination and intraoperative monitoring) Intraoperatively
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