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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinical assessment of flap perfusion | Placebo Comparator | Tailoring the flap according to clinical assessment of flap perfusion |
|
| Angiography assessment of flap perfusion | Experimental | Tailoring the flap according to ICG Angiography assessment of flap perfusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tailoring the flap according to clinical assessment | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with fat necrosis as assessed by physical examination | Six months postoperatively | |
| Number of participants with fat necrosis as assessed by ultrasonography | Six months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with flap failure as assessed by physical examination | From intraoperative moment to one week postoperatively | |
| Number of participants with wound infection as assessed by physical examination | From one day postoperatively to two weeks postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luis LandÃn Jarillo, MD, PhD | La Paz University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| La Paz University Hospital | Madrid | 28046 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31577664 | Derived | Varela R, Casado-Sanchez C, Zarbakhsh S, Diez J, Hernandez-Godoy J, Landin L. Outcomes of DIEP Flap and Fluorescent Angiography: A Randomized Controlled Clinical Trial. Plast Reconstr Surg. 2020 Jan;145(1):1-10. doi: 10.1097/PRS.0000000000006393. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 25, 2018 | |
| Reset | Oct 18, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 25, 2018 | Oct 18, 2018 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009389 | Neovascularization, Pathologic |
| D005218 | Fat Necrosis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
| Tailoring the flap according to ICG Angiography assessment | Procedure | 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. |
|
| Number of participants with wound healing delay as assessed by physical examination | From two weeks postoperatively to two months postoperatively |
| Number of participants with reoperation | From immediate postoperative moment to one year postoperatively |
| Flap perfusion index as assessed by IC-CALC software (Pulsion Medical System) | Intraoperatively |
| Flap weight (grams) | Intraoperatively |
| Flap length (centimeters) | Intraoperatively |
| Breast-Q questionnaire (preoperative reconstruction module) to measure patient preoperative status | A preoperative test in the last week before surgery |
| Breast-Q questionnaire (postoperative reconstruction module) to measure patient postoperative status | A postoperative test one year after surgery |
| ICG security (Number of participants with tachycardia, exanthema and anaphylactic shock as assessed by physical examination and intraoperative monitoring) | Intraoperatively |
| D017437 |
| Skin and Connective Tissue Diseases |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |