Breast Reconstruction Clinical Trial
Official title:
Impact of Drainless Donor Abdominal Site in Deep Inferior Epigastric Perforator (DIEP) Flap on Complications and Duration of Hospital Stay.
Inserting surgical drains is an ancient approach used across different specialties because of its many advantages such as discharge of fluid accumulation, appraising and qualifying drain capacities, lowering infection percentages, and eliminating dead space. Most commonly, abdominal closed-suction drains are used following autologous breast reconstruction with a DIEP flap to prevent donor site complications such as seroma, hematoma, and wound dehiscence. Although abdominal drains are effective in impeding accumulation, they are a potential portal for infection, Furthermore, they restrict patient mobility, are cumbersome, require time-consuming care upon discharge, potentially increase inpatient stay and ultimately resulting in impaired health-care costs. In the context of an Enhanced Rapid Protocol (ERP), not placing abdominal drains would be a step forward. This involves using "quilting sutures" to close the dead space after flap prelevation. Quilting sutures are placed between the subcutaneous tissues of the abdominal flap and the underlying fascia of the rectus abdominis muscle and aim to minimizes the shearing forces and collapse the death space without the use of drains. Progressive tension sutures were first described in 2000, in a retrospective paper on cosmetic abdominoplasty patients. Since then, their procedure has been analysed and adapted by many authors and applied in perforator-based abdominal flaps for breast reconstruction. Despite the drainless approach is well known in the literature for cosmetic abdominoplasty procedures, prospective clinical investigations to encourage the drainless approach in DIEP flap reconstruction is lacking. Therefore we want to set up a prospective study to make a comparison between the outcomes succeeding donor site closure after DIEP flap harvesting with (AD) or without (W-AD) the use of abdominal drains and investigate whether there is a correlation between the use of drains and the length of hospital stay. Secondary outcomes involve the complication rate of seroma, hematoma, and dehiscence analysis of abdominal drain output and postoperative recovery, including pain and follow-up complications as described above.
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03757793 -
Near-infrared Spectroscopy for Monitoring Tissue Oxygenation in Breast Reconstruction
|
||
Completed |
NCT05491473 -
Negative Pressure in PAP Donor Sites
|
||
Not yet recruiting |
NCT06013514 -
Post-market Prospective Clinical Study of Nagor Perle Mammary Implants
|
||
Completed |
NCT02169011 -
Secondary Breast Reconstruction With a Flap of Skin From the Back
|
N/A | |
Completed |
NCT01216319 -
Evaluation of the Cook Biodesign Plastic Surgery Matrix
|
N/A | |
Completed |
NCT01176786 -
Reusable Versus Disposable Draping System in Breast Reconstruction Surgery
|
N/A | |
Not yet recruiting |
NCT00973544 -
Do Closed Suction Drains Affect the Complications Rate of Breast Reconstruction With Silicone Prosthesis?
|
N/A | |
Active, not recruiting |
NCT00748722 -
Pre-Operative Imaging of Abdominal Wall Perforators Using CT Angiography
|
N/A | |
Completed |
NCT00753922 -
Core Gel Study of the Safety and Effectiveness of Mentor Round Low Bleed Silicone Gel-filled Mammary Prostheses
|
Phase 3 | |
Completed |
NCT05897463 -
Nipple Neurotization
|
||
Recruiting |
NCT05377723 -
Abdominal Scar Improvement in Microsurgical Breast Reconstruction
|
N/A | |
Completed |
NCT04350411 -
Comparison of PEAK PlasmaBladeā¢ to Conventional Diathermy in Abdominal Based Free Flap Breast Reconstruction
|
N/A | |
Completed |
NCT06321549 -
New Era of DIEP With Minimally Invasive Mastectomy
|
||
Withdrawn |
NCT03135392 -
Sensation After Nipple Sparing Mastectomy and Breast Reconstruction With or Without Neurotized Free Tissue Transfer
|
N/A | |
Completed |
NCT01256502 -
The SERI® Surgical Scaffold Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery
|
N/A | |
Active, not recruiting |
NCT04715802 -
Options on the Breast Reconstruction Timing and Method After Removal of Polyacrylamide Hydrogel
|
||
Active, not recruiting |
NCT04491591 -
Implementing BREASTChoice Into Practice
|
N/A | |
Recruiting |
NCT04661501 -
BREAST ADM Trial for Alloplastic Breast Reconstruction
|
N/A | |
Suspended |
NCT03625765 -
Integrated Imaging System for In Vivo Visualization of Free Flap Perfusion Using Indocyanine Dye
|
N/A | |
Withdrawn |
NCT00778947 -
Single Centre Study to Compare Harmonic Scalpel to Conventional Diathermy in Free Tissue Transfer Breast Reconstruction
|
N/A |