Back to resultsFirst-in-human, Study of MATTISSE® Tissue Engineering Chamber in Adult Female Patients Undergoing Immediate Breast Reconstruction After Mastectomy for Cancer (TIDE)
Primary Purpose
Breast Cancer Female, Breast Cancer Prevent, Breast Reconstruction
Status
Recruiting
Phase
Not Applicable
Locations
Georgia
Study Type
Interventional
Intervention
MATTISSE TEC
Sponsored by
About this trial
This is an interventional other trial for Breast Cancer Female
Eligibility Criteria
Inclusion Criteria:
Criteria related to pathology:
- Female patient 18 Years to 70 Years
- Immediate unilateral reconstruction after mastectomy for early breast cancer or Immediate Preventive unilateral reconstruction
- If patients with cancer: Patient with early cancer (carcinoma in situ without lymph node metastasis) with oncological management that does not required radiotherapy after surgery
- Nipple sparing (NSM) or Skin sparing mastectomy (SSM) with a unique surgical approach (same for mastectomy and implant) insertion
- Autologous reconstruction using Lateral Intercostal Perforator (LICAP) flap or an intercostal thoracic artery perforation flap (LTAP) if oncological conditions do not allow for LICAP harvesting.
- Patient medically fit for surgery without significant comorbidities
- Breast cup-size less than D
- Body mass index >20 kg/m2 or patient for whom sufficient flap volume is expected according to surgeon's assessment
- Adequate hematopoietic functions
Criteria related to population:
- Subjects who have given free, informed and written consent to participate in the study;
- Patient able to answer questionnaires, able to communicate in the language of the study country;
- Subjects affiliated to a social security schema or entitled to a social security scheme.
Exclusion Criteria:
Disease related criteria:
- Previous breast surgery
- Patient undergoing delayed or bilateral reconstructions
- Patient undergoing bilateral preventive mastectomy
- Patients undergoing simultaneous contralateral breast reduction, mastopexy, and augmentation
- Previous history of radiotherapy
- Presence of pacemaker or metallic prosthesis making patient unsuitable for MRI
- Body mass index >30 kg/m2
- Taking medication for weight loss at the time of inclusion visit
- Presence of major medical conditions that may compromise patient's health and healing diabetes and a history of gestational diabetes
- active smoking
- Microangiopathy, Vascular history and all systemic disease (systemic Raynaud's disease)
- Patient with intertrigo or infection or alteration of the surgical site confirmed pre-operatively by clinical examination
- Allergy to anesthetics or contrast media
- Immunocompromised patients (HIV) or patients used immunosuppressants
Medical device related criteria
- Allergy to any of the components of the medical device
Sites / Locations
- Institute of Clinical OncologyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MATTISSE TEC
Arm Description
Patient included receive MATTISSE TEC
Outcomes
Primary Outcome Measures
Safety objective: To assess the 6 months surgical complications rate of MATTISSE® TEC implant-based immediate breast reconstruction. Adverse events will be recorded.
Minor complications associated to MATTISSE® TEC:
Skin necrosis that requires only debridement
Flap necrosis
Subcutaneous hematoma: any hematoma requiring surgical exploration
Infection
Seroma: defined as that which requires echo-guided puncture at least once after drain removal.
Pain
Delayed wound healing/wound dehiscence: any wound healing problems, detected during clinical examination and not requiring an intervention
Implant malposition
Superficial Venous Thrombosis (Mondor disease)
Capsular contracture
Major complications associated to MATTISSE® TEC:
Necrosis of skin or flap
Infection
Prothesis exposure/ Implant malposition
Device failure or defect: when the prothesis breaks or collaps
Performance objective: To assess the efficacy at 6 months post-operation of breast reconstruction using MATTISSE® breast implants in patients undergoing breast reconstitution after total mastectomy surgery for cancer.
Success is defined as:
Tissue expansion (flap enlargement) from implantation up to 6 months post operation --> A 50% increase in the expanded size at 6 months compared to initial size flap is considered as a success. Indeed, the optimal growth of the flap is expected at 6 months,
Tissue expansion will be assessed using MRI at discharge (after surgery) and 6 months post operative. The volume of flap at 6 months will be compared to the flap size initially implanted. All MRI imaging will be assessed by and independent expert radiologist.
Failure is defined as:
less than 50% increase in the expanded size at 6 months compared to initial size flap MATTISSE® Prothesis removal
Secondary Outcome Measures
Evolution of tissue expansion (flap enlargement) from implantation up to 12 months post operation.
Tissue expansion will be assessed using MRI at discharge (after surgery), 3, 6 and 12 months post operative.
All MRI imaging will be assessed by and independent expert radiologist.
Evolution of breast softness from inclusion to 12 months
The breast softness will be assessed by investigator surgeon and patients themselves at discharge (after surgery), 3, 6 and 12 months as:
Stage 1: Breast is soft
Stage 2: Breast is hard
Stage 3: Breast is hard with distortion
Stage 4: Breast is hard, painful with distortion
Evolution of MATTISSE® TEC resorption until 12 months follow up: the resorption is active between 6 and 12 months after surgery. At 12 months the resorption of MATTISSE® TEC is not complete.
MATTISSE® TEC resorption will be observed quantitatively on MRI achieved at 3, 6 and 12 months associated with the touch of the surgeon and patients feeling. The TEC resorption will be classified as:
Absent: no resorption at all.
Small resorption: TEC has been reabsorbed a little bit compared to the initial
Great resorption: TEC has been absorbed a lot but not totally
Total: Shell and base are no longer visible on the MRI and not felt by the surgeon
The volume of the reconstructed breast compared to the volume of the contralateral one at 12 months
At 12 months, we will assess during physical examinations, the volume of the reconstructed breast and the volume of the contralateral one.
Aesthetic breast appearance before and after surgery using photo
Aesthetic breast appearance will be assessed before surgery, 6 and 12-months post-surgery using standardized photographs. The assessment will be done by the surgeon and 2 independent external specialists who validated standardized photographs.
The following scoring points will be used:
Excellent: Treated breast nearly identical to that before surgery
Good: Treated breast slightly different to that before surgery
Fair: Treated breast clearly different to that before surgery but not seriously distorted
Poor: Treated breast seriously distorted compared to that before surgery
The maintain of breast (i.e., flap) volume stability at 12 months compared to that at 6 months
Flap volume at 12 months is compared at that assessed at 6 months using MRI. All MRI imaging will be assessed by and independent expert radiologist.
The impact of the flap transfer on the donor site assessed at surgery, 3-, 6- and 12-months post-surgery
Impact of the flap transfer on the donor site will be assessed at surgery, 3-, 6- and 12-months post-surgery using different parameters:
Tissue necrosis (Yes/ No)
Symmetry of the donor site area (comparing to the other side of the patient): Yes/ No
Pain (VAS)
Pain score will be assessed at inclusion, discharge, M3, M6 and M12 using a 10 Visual Analogue Scale [VAS, 0 (no pain) and 10 (worst possible pain)]
The quality of life and the satisfaction of patients
Quality of life and patients' satisfaction will be done through the BREAST-Q© questionnaire (module of reconstruction pre and post-surgery version) at inclusion and at 3, 6 and 12 months post operative. The quality of life is evaluated through 2 scales (psychological well-being and physical well-being: breast).
The satisfaction is evaluated with 1 scale : (satisfaction with breast).
Surgeon satisfaction regarding the use of MATTISSE® TEC and implantation procedure.
- Surgeons' satisfaction regarding the use of MATTISSE® TEC and implantation procedure will be assessed on: Global satisfaction of the surgeon (5 points Likert scale)
Ease of use
Material ergonomics
Ease of insertion
Ease of fixing
Safety up to 12 months, will be assessed by measuring the complication rate in implant-based immediate breast reconstruction using MATTISSE® TEC. Adverse events up to 12 months post operation will be recorded.
Safety up to 24 months post operation
Minor complications associated to MATTISSE® TEC
Skin necrosis that requires only debridement
Flap necrosis
Subcutaneous hematoma: any hematoma requiring surgical exploration
Infection
Seroma: defined as that which requires echo-guided puncture at least once after drain removal.
Pain
Delayed wound healing/wound dehiscence: any wound healing problems, detected during clinical examination and not requiring an intervention
Implant malposition
Superficial Venous Thrombosis (Mondor disease)
Capsular contracture
Major complications associated to MATTISSE® TEC:
Necrosis of skin or flap
Infection
Prothesis exposure/ Implant malposition
Device failure or defect: when the prothesis breaks or collaps
Full Information
NCT ID
NCT05460780
First Posted
July 12, 2022
Last Updated
July 15, 2022
Sponsor
Quanta Medical
Collaborators
Lattice Medical
1. Study Identification
Unique Protocol Identification Number
NCT05460780
Brief Title
First-in-human, Study of MATTISSE® Tissue Engineering Chamber in Adult Female Patients Undergoing Immediate Breast Reconstruction After Mastectomy for Cancer
Acronym
TIDE
Official Title
First-in-human, Study of MATTISSE® Tissue Engineering Chamber in Adult Female Patients Undergoing Immediate Breast Reconstruction After Mastectomy for Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
October 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Quanta Medical
Collaborators
Lattice Medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is a first in human, two-stage single arm non-comparative study of safety and performance.
The aim of the study is to asses the safety and the clinical performance of a new device : the MATTISSE tissu engineering chamber.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Female, Breast Cancer Prevent, Breast Reconstruction
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MATTISSE TEC
Arm Type
Experimental
Arm Description
Patient included receive MATTISSE TEC
Intervention Type
Device
Intervention Name(s)
MATTISSE TEC
Intervention Description
Tissue engineering chamber MATTISSE
Primary Outcome Measure Information:
Title
Safety objective: To assess the 6 months surgical complications rate of MATTISSE® TEC implant-based immediate breast reconstruction. Adverse events will be recorded.
Description
Minor complications associated to MATTISSE® TEC:
Skin necrosis that requires only debridement
Flap necrosis
Subcutaneous hematoma: any hematoma requiring surgical exploration
Infection
Seroma: defined as that which requires echo-guided puncture at least once after drain removal.
Pain
Delayed wound healing/wound dehiscence: any wound healing problems, detected during clinical examination and not requiring an intervention
Implant malposition
Superficial Venous Thrombosis (Mondor disease)
Capsular contracture
Major complications associated to MATTISSE® TEC:
Necrosis of skin or flap
Infection
Prothesis exposure/ Implant malposition
Device failure or defect: when the prothesis breaks or collaps
Time Frame
6 months post-surgery
Title
Performance objective: To assess the efficacy at 6 months post-operation of breast reconstruction using MATTISSE® breast implants in patients undergoing breast reconstitution after total mastectomy surgery for cancer.
Description
Success is defined as:
Tissue expansion (flap enlargement) from implantation up to 6 months post operation --> A 50% increase in the expanded size at 6 months compared to initial size flap is considered as a success. Indeed, the optimal growth of the flap is expected at 6 months,
Tissue expansion will be assessed using MRI at discharge (after surgery) and 6 months post operative. The volume of flap at 6 months will be compared to the flap size initially implanted. All MRI imaging will be assessed by and independent expert radiologist.
Failure is defined as:
less than 50% increase in the expanded size at 6 months compared to initial size flap MATTISSE® Prothesis removal
Time Frame
6 months post-surgery
Secondary Outcome Measure Information:
Title
Evolution of tissue expansion (flap enlargement) from implantation up to 12 months post operation.
Description
Tissue expansion will be assessed using MRI at discharge (after surgery), 3, 6 and 12 months post operative.
All MRI imaging will be assessed by and independent expert radiologist.
Time Frame
Surgery visit, 3, 6, and 12 months post-intervention (24 months post intervention for 10 first patient)
Title
Evolution of breast softness from inclusion to 12 months
Description
The breast softness will be assessed by investigator surgeon and patients themselves at discharge (after surgery), 3, 6 and 12 months as:
Stage 1: Breast is soft
Stage 2: Breast is hard
Stage 3: Breast is hard with distortion
Stage 4: Breast is hard, painful with distortion
Time Frame
Surgery visit, 3, 6, and 12 months post-intervention (24 months post intervention for 10 first patient)
Title
Evolution of MATTISSE® TEC resorption until 12 months follow up: the resorption is active between 6 and 12 months after surgery. At 12 months the resorption of MATTISSE® TEC is not complete.
Description
MATTISSE® TEC resorption will be observed quantitatively on MRI achieved at 3, 6 and 12 months associated with the touch of the surgeon and patients feeling. The TEC resorption will be classified as:
Absent: no resorption at all.
Small resorption: TEC has been reabsorbed a little bit compared to the initial
Great resorption: TEC has been absorbed a lot but not totally
Total: Shell and base are no longer visible on the MRI and not felt by the surgeon
Time Frame
Surgery visit, 3, 6, and 12 months post-intervention (24 months post intervention for 10 first patient)
Title
The volume of the reconstructed breast compared to the volume of the contralateral one at 12 months
Description
At 12 months, we will assess during physical examinations, the volume of the reconstructed breast and the volume of the contralateral one.
Time Frame
3, 6, 12, (and 24 for the 10 firsts patient inclueded) months post surgery
Title
Aesthetic breast appearance before and after surgery using photo
Description
Aesthetic breast appearance will be assessed before surgery, 6 and 12-months post-surgery using standardized photographs. The assessment will be done by the surgeon and 2 independent external specialists who validated standardized photographs.
The following scoring points will be used:
Excellent: Treated breast nearly identical to that before surgery
Good: Treated breast slightly different to that before surgery
Fair: Treated breast clearly different to that before surgery but not seriously distorted
Poor: Treated breast seriously distorted compared to that before surgery
Time Frame
3, 6, 12, (and 24 for the 10 firsts patient inclueded) months post surgery
Title
The maintain of breast (i.e., flap) volume stability at 12 months compared to that at 6 months
Description
Flap volume at 12 months is compared at that assessed at 6 months using MRI. All MRI imaging will be assessed by and independent expert radiologist.
Time Frame
3, 6, 12, (and 24 for the 10 firsts patient inclueded) months post surgery
Title
The impact of the flap transfer on the donor site assessed at surgery, 3-, 6- and 12-months post-surgery
Description
Impact of the flap transfer on the donor site will be assessed at surgery, 3-, 6- and 12-months post-surgery using different parameters:
Tissue necrosis (Yes/ No)
Symmetry of the donor site area (comparing to the other side of the patient): Yes/ No
Time Frame
3, 6, 12, (and 24 for the 10 firsts patient inclueded) months post surgery
Title
Pain (VAS)
Description
Pain score will be assessed at inclusion, discharge, M3, M6 and M12 using a 10 Visual Analogue Scale [VAS, 0 (no pain) and 10 (worst possible pain)]
Time Frame
3, 6, 12, (and 24 for the 10 firsts patient inclueded) months post surgery
Title
The quality of life and the satisfaction of patients
Description
Quality of life and patients' satisfaction will be done through the BREAST-Q© questionnaire (module of reconstruction pre and post-surgery version) at inclusion and at 3, 6 and 12 months post operative. The quality of life is evaluated through 2 scales (psychological well-being and physical well-being: breast).
The satisfaction is evaluated with 1 scale : (satisfaction with breast).
Time Frame
3, 6, 12, (and 24 for the 10 firsts patient inclueded) months post surgery
Title
Surgeon satisfaction regarding the use of MATTISSE® TEC and implantation procedure.
Description
- Surgeons' satisfaction regarding the use of MATTISSE® TEC and implantation procedure will be assessed on: Global satisfaction of the surgeon (5 points Likert scale)
Ease of use
Material ergonomics
Ease of insertion
Ease of fixing
Safety up to 12 months, will be assessed by measuring the complication rate in implant-based immediate breast reconstruction using MATTISSE® TEC. Adverse events up to 12 months post operation will be recorded.
Time Frame
3, 6, 12, (and 24 for the 10 firsts patient inclueded) months post surgery
Title
Safety up to 24 months post operation
Description
Minor complications associated to MATTISSE® TEC
Skin necrosis that requires only debridement
Flap necrosis
Subcutaneous hematoma: any hematoma requiring surgical exploration
Infection
Seroma: defined as that which requires echo-guided puncture at least once after drain removal.
Pain
Delayed wound healing/wound dehiscence: any wound healing problems, detected during clinical examination and not requiring an intervention
Implant malposition
Superficial Venous Thrombosis (Mondor disease)
Capsular contracture
Major complications associated to MATTISSE® TEC:
Necrosis of skin or flap
Infection
Prothesis exposure/ Implant malposition
Device failure or defect: when the prothesis breaks or collaps
Time Frame
3, 6, 12, (and 24 for the 10 firsts patient inclueded) months post surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Criteria related to pathology:
Female patient 18 Years to 70 Years
Immediate unilateral reconstruction after mastectomy for early breast cancer or Immediate Preventive unilateral reconstruction
If patients with cancer: Patient with early cancer (carcinoma in situ without lymph node metastasis) with oncological management that does not required radiotherapy after surgery
Nipple sparing (NSM) or Skin sparing mastectomy (SSM) with a unique surgical approach (same for mastectomy and implant) insertion
Autologous reconstruction using Lateral Intercostal Perforator (LICAP) flap or an intercostal thoracic artery perforation flap (LTAP) if oncological conditions do not allow for LICAP harvesting.
Patient medically fit for surgery without significant comorbidities
Breast cup-size less than D
Body mass index >20 kg/m2 or patient for whom sufficient flap volume is expected according to surgeon's assessment
Adequate hematopoietic functions
Criteria related to population:
Subjects who have given free, informed and written consent to participate in the study;
Patient able to answer questionnaires, able to communicate in the language of the study country;
Subjects affiliated to a social security schema or entitled to a social security scheme.
Exclusion Criteria:
Disease related criteria:
Previous breast surgery
Patient undergoing delayed or bilateral reconstructions
Patient undergoing bilateral preventive mastectomy
Patients undergoing simultaneous contralateral breast reduction, mastopexy, and augmentation
Previous history of radiotherapy
Presence of pacemaker or metallic prosthesis making patient unsuitable for MRI
Body mass index >30 kg/m2
Taking medication for weight loss at the time of inclusion visit
Presence of major medical conditions that may compromise patient's health and healing diabetes and a history of gestational diabetes
active smoking
Microangiopathy, Vascular history and all systemic disease (systemic Raynaud's disease)
Patient with intertrigo or infection or alteration of the surgical site confirmed pre-operatively by clinical examination
Allergy to anesthetics or contrast media
Immunocompromised patients (HIV) or patients used immunosuppressants
Medical device related criteria
Allergy to any of the components of the medical device
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre GUERRESCHI, Pr
Phone
+33 (0) 1 47 08 63 41
Email
b.hill@quanta-medical.com
Facility Information:
Facility Name
Institute of Clinical Oncology
City
Tbilissi
ZIP/Postal Code
0159
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gia NEMSADZE, Pr
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22094739
Citation
Findlay MW, Dolderer JH, Trost N, Craft RO, Cao Y, Cooper-White J, Stevens G, Morrison WA. Tissue-engineered breast reconstruction: bridging the gap toward large-volume tissue engineering in humans. Plast Reconstr Surg. 2011 Dec;128(6):1206-1215. doi: 10.1097/PRS.0b013e318230c5b2.
Results Reference
background
PubMed Identifier
23394225
Citation
Matsuda K, Falkenberg KJ, Woods AA, Choi YS, Morrison WA, Dilley RJ. Adipose-derived stem cells promote angiogenesis and tissue formation for in vivo tissue engineering. Tissue Eng Part A. 2013 Jun;19(11-12):1327-35. doi: 10.1089/ten.TEA.2012.0391. Epub 2013 Mar 28.
Results Reference
background
PubMed Identifier
31548545
Citation
Harbeck N, Penault-Llorca F, Cortes J, Gnant M, Houssami N, Poortmans P, Ruddy K, Tsang J, Cardoso F. Breast cancer. Nat Rev Dis Primers. 2019 Sep 23;5(1):66. doi: 10.1038/s41572-019-0111-2.
Results Reference
result
PubMed Identifier
26835456
Citation
Schmauss D, Machens HG, Harder Y. Breast Reconstruction after Mastectomy. Front Surg. 2016 Jan 19;2:71. doi: 10.3389/fsurg.2015.00071. eCollection 2015.
Results Reference
result
PubMed Identifier
11391187
Citation
Tzafetta K, Ahmed O, Bahia H, Jerwood D, Ramakrishnan V. Evaluation of the factors related to postmastectomy breast reconstruction. Plast Reconstr Surg. 2001 Jun;107(7):1694-701. doi: 10.1097/00006534-200106000-00009.
Results Reference
result
PubMed Identifier
18626347
Citation
Vega S, Smartt JM Jr, Jiang S, Selber JC, Brooks CJM, Herrera HR, Serletti JM. 500 Consecutive patients with free TRAM flap breast reconstruction: a single surgeon's experience. Plast Reconstr Surg. 2008 Aug;122(2):329-339. doi: 10.1097/PRS.0b013e31817f45cb.
Results Reference
result
PubMed Identifier
23542837
Citation
Duggal CS, Grudziak J, Metcalfe DB, Carlson GW, Losken A. The effects of breast size in unilateral postmastectomy breast reconstruction. Ann Plast Surg. 2013 May;70(5):506-12. doi: 10.1097/SAP.0b013e318263f1f8.
Results Reference
result
PubMed Identifier
19952638
Citation
Noone RB. Thirty-five years of breast reconstruction: eleven lessons to share. Plast Reconstr Surg. 2009 Dec;124(6):1820-1827. doi: 10.1097/PRS.0b013e3181bf821a. No abstract available.
Results Reference
result
PubMed Identifier
21285756
Citation
Salzberg CA, Ashikari AY, Koch RM, Chabner-Thompson E. An 8-year experience of direct-to-implant immediate breast reconstruction using human acellular dermal matrix (AlloDerm). Plast Reconstr Surg. 2011 Feb;127(2):514-524. doi: 10.1097/PRS.0b013e318200a961.
Results Reference
result
PubMed Identifier
27211566
Citation
Morrison WA, Marre D, Grinsell D, Batty A, Trost N, O'Connor AJ. Creation of a Large Adipose Tissue Construct in Humans Using a Tissue-engineering Chamber: A Step Forward in the Clinical Application of Soft Tissue Engineering. EBioMedicine. 2016 Apr;6:238-245. doi: 10.1016/j.ebiom.2016.03.032. Epub 2016 Mar 23.
Results Reference
result
PubMed Identifier
22395342
Citation
Petit JY, Rietjens M, Lohsiriwat V, Rey P, Garusi C, De Lorenzi F, Martella S, Manconi A, Barbieri B, Clough KB. Update on breast reconstruction techniques and indications. World J Surg. 2012 Jul;36(7):1486-97. doi: 10.1007/s00268-012-1486-3.
Results Reference
result
PubMed Identifier
16980842
Citation
Cordeiro PG, McCarthy CM. A single surgeon's 12-year experience with tissue expander/implant breast reconstruction: part I. A prospective analysis of early complications. Plast Reconstr Surg. 2006 Sep 15;118(4):825-831. doi: 10.1097/01.prs.0000232362.82402.e8.
Results Reference
result
PubMed Identifier
23761525
Citation
Martindale V, Menache A. The PIP scandal: an analysis of the process of quality control that failed to safeguard women from the health risks. J R Soc Med. 2013 May;106(5):173-7. doi: 10.1177/0141076813480994. No abstract available.
Results Reference
result
PubMed Identifier
11103081
Citation
Mian R, Morrison WA, Hurley JV, Penington AJ, Romeo R, Tanaka Y, Knight KR. Formation of new tissue from an arteriovenous loop in the absence of added extracellular matrix. Tissue Eng. 2000 Dec;6(6):595-603. doi: 10.1089/10763270050199541.
Results Reference
result
PubMed Identifier
10657450
Citation
Tanaka Y, Tsutsumi A, Crowe DM, Tajima S, Morrison WA. Generation of an autologous tissue (matrix) flap by combining an arteriovenous shunt loop with artificial skin in rats: preliminary report. Br J Plast Surg. 2000 Jan;53(1):51-7. doi: 10.1054/bjps.1999.3186.
Results Reference
result
PubMed Identifier
12621190
Citation
Hofer SO, Knight KM, Cooper-White JJ, O'Connor AJ, Perera JM, Romeo-Meeuw R, Penington AJ, Knight KR, Morrison WA, Messina A. Increasing the volume of vascularized tissue formation in engineered constructs: an experimental study in rats. Plast Reconstr Surg. 2003 Mar;111(3):1186-92; discussion 1193-4. doi: 10.1097/01.PRS.0000046034.02158.EB.
Results Reference
result
PubMed Identifier
14707645
Citation
Cronin KJ, Messina A, Knight KR, Cooper-White JJ, Stevens GW, Penington AJ, Morrison WA. New murine model of spontaneous autologous tissue engineering, combining an arteriovenous pedicle with matrix materials. Plast Reconstr Surg. 2004 Jan;113(1):260-9. doi: 10.1097/01.PRS.0000095942.71618.9D.
Results Reference
result
PubMed Identifier
19935290
Citation
Findlay MW, Messina A, Thompson EW, Morrison WA. Long-term persistence of tissue-engineered adipose flaps in a murine model to 1 year: an update. Plast Reconstr Surg. 2009 Oct;124(4):1077-1084. doi: 10.1097/PRS.0b013e3181b59ff6.
Results Reference
result
PubMed Identifier
32678237
Citation
Faglin P, Gradwohl M, Depoortere C, Germain N, Drucbert AS, Brun S, Nahon C, Dekiouk S, Rech A, Azaroual N, Maboudou P, Payen J, Danze PM, Guerreschi P, Marchetti P. Rationale for the design of 3D-printable bioresorbable tissue-engineering chambers to promote the growth of adipose tissue. Sci Rep. 2020 Jul 16;10(1):11779. doi: 10.1038/s41598-020-68776-8.
Results Reference
result
PubMed Identifier
33672918
Citation
Gradwohl M, Chai F, Payen J, Guerreschi P, Marchetti P, Blanchemain N. Effects of Two Melt Extrusion Based Additive Manufacturing Technologies and Common Sterilization Methods on the Properties of a Medical Grade PLGA Copolymer. Polymers (Basel). 2021 Feb 14;13(4):572. doi: 10.3390/polym13040572.
Results Reference
result
Links:
URL
http://www.who.int/fr/news-room/fact-sheets/detail/breast-cancer
Description
Related Info
Learn more about this trial
First-in-human, Study of MATTISSE® Tissue Engineering Chamber in Adult Female Patients Undergoing Immediate Breast Reconstruction After Mastectomy for Cancer
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