Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Patients undergoing breast reconstruction using a Contour Profile Tissue Expander (CPX3).

The Contour Profile Tissue Expander is a tissue expander with a greater height to width ratio than traditional tissue expanders. This increased ratio allows for greater lower pole expansion, thus creating a more natural looking, ptotic breast. Additionally, the suture tabs on the back of the expander hold the expander in place and prevent malposition and displacement.

Contour Profile Tissue Expander

John YS Kim, MD, MA

The purpose of this study is to explore the volume change and location of volume change in reconstructed breasts using the Contour Profile® tissue expander. Our purpose is also to investigate the safety of using CPX3® in tissue-expander breast reconstruction via a comparison between the complication rates that result from this study and the complication rates with the use of other tissue expander types, as reported in the literature. We also hope to demonstrate the use of 3-D imaging technology as an objective measure of upper and lower breast volume change and location of this volume change in the reconstructed breast. Finally, we intend to provide reconstructive surgeons with a scientific study that quantifies the patient satisfaction with aesthetic results of CPX3 in tissue expander-implant breast reconstruction. We hypothesize that the CPX3 tissue expander will provide more lower pole volume expansion when compared to lower pole volume expansion from round, standard tissue expanders as reported in the literature. Additionally, we hypothesize that CPX3, in combination with human acellular dermis, is less prone to complications than standard tissue expanders (again, as reported in the literature).

Tissue expansion is an accepted and widely used method for breast reconstruction. A drawback in using standard tissue expanders is unwanted fullness at the upper pole and insufficient expansion at the lower pole of the breast. Round expanders can result in poor ptosis (sagging) because of unwanted upper pole fullness and are not without risk for complications\[1, 2\]. Anatomically-shaped expanders also have shortcomings and complications such as malposition\[3-7\]. A tissue expander designed to counteract upper pole fullness is necessary to achieve a more natural appearing ptotic breast with a well-defined inframammary fold (IMF)\[8\]. The inframammary fold is the crease below the breast where the breast meets the chest wall. Mentor's Contour Profile® (CPX3) tissue expander provides a design with a greater height to width ratio for greater lower pole expansion. It also has suture tabs on the back of the expander to hold the expander in place and prevent malposition. Another recent advancement in tissue expander breast reconstruction is the use of cadaveric-derived human acellular dermis for rapid intraoperative expansion and early projection\[9-14\].

The crescent-shaped expander has been studied by John YS Kim, MD in a retrospective review of 40 consecutive patients who underwent acellular dermis assisted breast reconstruction. He found the crescentric tissue expansion with acellular dermis is well tolerated with high patient and surgeon satisfaction likely due to selective lower pole expansion related to the crescent shape, as well as significant immediate expansion related to larger subpectoral pockets.

To date, no studies have been reported that investigate the lower pole expansion resulting from varying tissue expander dimensions with objective computer software\[15, 16\]. The advent of three-dimensional imaging technology to objectively measure lower pole expansion provides a quantitative means to study the advantages of using the CPX3® tissue expander. We propose a study that will show whether or not the CPX3® tissue expander's unique design can have an ultimate effect on the shape and location of volume change on the postoperative breast. Three-dimensional cameras also provide an advantage for assessing patients undergoing bilateral mastectomy and reconstruction who desire a reconstructive outcome that will bear some resemblance to their current breasts \[15\].

The 3-D imaging calculation evaluates the following parameters: absolute volume, absolute volume change, location of expansion, base width, breast projection and contour symmetry. Older methods of volume assessment would assume that the base of the breast is a flat plane. The Vectra system takes into account the curvature of the chest wall, which results in a more accurate breast volume measurement. With 3-D imaging there is no exposure to radiation\[16\]. Another advantage to 3-D imaging is the option to view the subject's image at any angle, 360 degrees\[17\]. Our study would show the postoperative results of using the CPX3® tissue expander with an objective analysis of the degree of lower-pole expansion.

This will be a prospective study. Fifteen patients will be enrolled and will receive a Contour profile tissue expander (CPX3) during their reconstruction.

Tissue Expander Breast Reconstruction Study on Breast Volume and Shape Change

The Contour Profile® Tissue Expander in Immediate Breast Reconstruction: A Three-Dimensional Look Into Shape and Volume Changes

The primary outcome of interest for this study was the change in breast projection from the time of maximum tissue expander fill volume, to 3 months after the tissue expander/implant exchange surgery. Upon final fill of the tissue expander, the breast has a certain projection. Once the fully expanded tissue expander is exchanged for the permanent implant, the patients' breast projection changes gradually over time. The change in breast projection is measured in percent change of projection from baseline (the time of the final, maximum expander fill) to 3 months after the tissue expander/implant exchange surgery (at which time a change in projection has occurred).

Mentor Worldwide, LLC

Northwestern University

Associate Professor Division of Plastic and Reconstructive Surgery

Patients undergoing breast reconstruction using a Contour Profile Tissue Expander (CPX3).

Contour Profile Tissue Expander: The Contour Profile Tissue Expander is a tissue expander with a greater height to width ratio than traditional tissue expanders. This increased ratio allows for greater lower pole expansion, thus creating a more natural looking, ptotic breast. Additionally, the suture tabs on the back of the expander hold the expander in place and prevent malposition and displacement.

Contour Profile Tissue Exander

Age, Continuous

Sex: Female, Male

The number of subjects studied is small; projection measurements may have been subject to human error.

John Y.S. Kim, MD

Breast Projection

Overall Study

Breast Diseases

Skin Diseases

Superficial Inferior Epigastric Artery Clamped; Vein Unclamped

Perfusion assessed in Zone IV of the DIEP flap whilst both the contralateral Superficial Inferior Epigastric Artery and Vein are clamped

Both Superficial Inferior Artery and Vein Clamped

Perfusion assessed in Zone IV of the DIEP flap whilst both the contralateral Superficial Inferior Epigastric Artery and Vein are unclamped

Superficial Inferior Epigastric Vessels both unclamped

Perfusion assessed in Zone IV of the DIEP flap whilst the contralateral Superficial Inferior Epigastric Artery is unclamped and the Vein is clamped

SIE Artery Unclamped, Vein Clamped

Perfusion assessed in Zone IV of the DIEP flap whilst the contralateral Superficial Inferior Epigastric Artery is clamped and the Vein is unclamped

SIE Artery clamped, Vein unclamped

Adam Gilmour, MBChB, MRCS (Ed)

The purpose of this study is to determine in-vivo the effects the contralateral superficial inferior epigastric vascular system has on the perfusion of Zone IV of deep inferior epigastric perforator flaps.

* Breast cancer is the commonest cancer to affect women in the UK. Current guidelines state that; disease permitting, all females due to undergo mastectomy for breast cancer should be offered reconstruction. Autologous free tissue transfer using abdominal tissue remains an excellent option for breast reconstruction due the readily available fatty tissue and the low donor site morbidity. In recent years the trend has been to base the abdominal tissue on perforating vessels rather than to routinely harvest muscle along with the flap; thus further potentially reducing donor site morbidity. Abdominal tissue based upon the Deep Inferior Epigastric Perforator (DIEP) system is a well recognised option in breast reconstruction.
* This procedure involves harvesting the lower abdominal tissue basing its blood supply on one of the Deep Inferior Epigastric Perforating Arteries and concomitant veins. These are branches of the External iliac artery which perforate through the rectus muscle or the intertendinous intersections.
* A large volume of tissue can be harvested based on a single perforator.
* Hartrampf divided the abdominal tissues into distinct perfusion zones I-IV based upon their location to the perforating artery. Zone I overlies the perforating vessel, Zone II is across the midline adjacent to perforating vessel. Zone III is on the ipsilateral periphery to the perforating vessel and Zone IV is on the furthest periphery on the contralateral side from the perforator. Over the years this has undergone debate and many have advocated that zones II-III (according to Hartrampfs original classification) should be switched. However everyone remains clear on the term Zone IV. Zone IV is classically the area of the flap which receives least perfusion/drainage from the perforating vessels and as such is most liable to undergo congestion and tissue ischaemia leading to fat/skin necrosis. As such many surgeons routinely excise zone IV from the DIEP flap prior to transfer to the chest defect. This obviously leads to a reduction in the volume of tissue available for reconstruction.
* Classically most problems with zone IV / flap perfusion tend to be related to venous congestion.
* Many surgeons advocate the use of the superficial inferior epigastric vein as a "lifeboat" vessel in salvaging a congested DIEP and have published their results in doing so.
* There are however no in-vivo studies showing the full contribution of the superficial vascular system in flaps based primarily upon the Deep Inferior Epigastric Perforating Vessels. A recent study using preoperative CTs has shown that there are "macrovascular-shunts" between the deep arterial system and the superficial venous system but the implications of this have yet to be established.
* Fluoroscopy using indocyanine green is an established method at looking at tissue perfusion in free flaps.
* Laser Doppler imaging is another well described technique for the monitoring / assessment of tissue perfusion in plastic surgery operations.
* By further understanding the perfusion of the DIEP flaps the investigators hope to improve flap survivability and also the volume of flap which can be used.
* Patients due to undergo breast reconstruction with a free DIEP flap by the senior researcher/surgeon will be identified.
* On the day of their operation the DIEP flap will be raised as normal on one of the DIEP arteries from either side. The superficial vascular system will be dissected free on the contralateral side.
* The flap will then be scanned with Laser Doppler Imaging and then the SPY scanner (indocyanine green angiography coupled with fluoroscopy)
* This will take place in a randomized fashion as follows
* Superficial Inferior Epigastric Artery Clamped; Vein Unclamped
* Superficial Inferior Epigastric Artery Unclamped; Vein Clamped
* Both Artery and Vein Clamped
* Both Artery And Vein Unclamped
* There will be a 5minute pause between each intervention to allow perfusion to stabilize. Previous research (awaiting publication) within our department has shown that this is the necessary amount of time to allow stabilization.
* The scanning period will be carried out during the natural rest break of the operating surgeon and as such will not add significantly to the length of the procedure.
* Once the scanning process is finished the operation will then proceed as standard with DIEP flap being disconnected from the abdomen and reconnected in the chest to reconstruct the breast.

Influence of the Superficial Inferior Epigastric System in Deep Inferior Epigastric Perforator (DIEP) Flaps

The Potential Role of the Superficial Inferior Epigastric Vascular System in the Perfusion of Zone IV of Deep Inferior Epigastric Perforator (DIEP) Flaps

Tissue Perfusion to Zone IV will be assessed intra-operatively using Laser Doppler Imaging and angiography whilst various components of the Contralateral Superficial Inferior Epigastic Artery / Vein are clamped/unclamped.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Tissue Expander Breast Reconstruction Study on Breast Volume and Shape Change	NCT01222390	Contour Irregul...	Contour Profile...	25 Years - 85 Years	Northwestern University
Influence of the Superficial Inferior Epigastric System in Deep Inferior Epigastric Perforator (DIEP) Flaps	NCT01464970	Breast Cancer	Both Superficia... Superficial Inf... SIE Artery Uncl... SIE Artery clam...	18 Years - 70 Years	NHS Greater Glasgow and Clyde
Influence of the Superficial Inferior Epigastric System in Deep Inferior Epigastric Perforator (DIEP) Flaps	NCT01464970	Breast Cancer	Both Superficia... Superficial Inf... SIE Artery Uncl... SIE Artery clam...	18 Years - 70 Years	NHS Greater Glasgow and Clyde

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