Neoplasms

Digestive System Diseases

All Conditions

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Perineal reconstruction and stoma reinforcement with Strattice

Strattice

Baljit Singh, FRCS, FACS

Sanjay Chaudhri, FRCS

Per J Nilsson, MD

Pierre J Maina, MD

W Bemelman, MD

This is a prospective, multicenter, single arm, observational pilot study to assess the clinical outcomes of Strattice Reconstructive Tissue Matrix for perineal reconstruction following eLAPE and simultaneous stoma reinforcement.

About 40 subjects will be enrolled from 4 centers over approx 24 months. Subjects will all be undergoing extralevator abdominoperineal excision with concomitant ostomy creation.

Perineal Reconstruction Following eLAPE and Simultaneous Stoma Sublay Reinforcement

Perineal Reconstruction Following Extralevator Abdominoperineal Excision of Rectum and Simultaneous Stoma Sublay Reinforcement

Perineal wound healing will be assessed using the Southamptom Wound Scoring System and perineal pain assessed using a visual analogue scale (VAS) daily during hospital stay and then POD 7, 30 and months 3, 6 and 12.

Stoma will be assessed for herniation at Months 3, 6, 12 and 24

Karolinska University Hospital

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Slagelse Hospital

University Hospitals, Leicester

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Rare Diseases

Hernia

Fistula

Hernia, Ventral

Peritoneal Neoplasms

Fibromatosis, Aggressive

Intestinal Fistula

Fibromatosis, Abdominal

Fibroma

Pathological Conditions, Anatomical

Neoplasms, Fibrous Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Hernia, Abdominal

Digestive System Fistula

Desmoid Tumor

Abdominal wall reconstruction with Strattice Assess pain intensity at last office visit preoperatively Assess pain interference at last office visit preoperatively Assess physical functioning at last office visit preoperatively Assess patient quality of life at last office visit preoperatively Assess patient pain intensity postoperatively Assess pain interference postoperatively Assess physical functioning postoperatively Assess quality of life postoperatively Assess hernia recurrence at 30 days postoperatively Assess bulge at 30 days postoperatively Assess Surgical Site Occurrences at 30 days postoperatively Assess hernia recurrence at 1 year postoperatively Assess bulge at 1 year postoperatively Assess Surgical Site Occurrences at 1 year postoperatively Assess overall complications at 30 days postoperatively Assess overall complications at 1 year postoperatively

Abdominal wall reconstruction with XenMatrix Assess pain intensity at last office visit preoperatively Assess pain interference at last office visit preoperatively Assess physical functioning at last office visit preoperatively Assess patient quality of life at last office visit preoperatively Assess patient pain intensity postoperatively Assess pain interference postoperatively Assess physical functioning postoperatively Assess quality of life postoperatively Assess hernia recurrence at 30 days postoperatively Assess bulge at 30 days postoperatively Assess Surgical Site Occurrences at 30 days postoperatively Assess hernia recurrence at 1 year postoperatively Assess bulge at 1 year postoperatively Assess Surgical Site Occurrences at 1 year postoperatively Assess overall complications at 30 days postoperatively Assess overall complications at 1 year postoperatively

Abdominal wall reconstruction using Strattice

Abdominal wall reconstruction with Strattice

Assess patient pain intensity preoperatively using the PROMIS Pain Intensity survey (average of 1-3 weeks preoperatively)

Assess pain intensity at last office visit preoperatively

Assess pain interference preoperatively using the PROMIS pain interference survey (average of 1-3 weeks preoperatively)

Assess pain interference at last office visit preoperatively

Assess physical functioning preoperatively using the PROMIS physical functioning survey (average of 1-3 weeks preoperatively)

Assess physical functioning at last office visit preoperatively

Assess patient quality of life preoperatively, using the HerQLes survey (average of 1-3 weeks preoperatively)

Assess patient quality of life at last office visit preoperatively

Assess patient pain intensity at 1 year postoperatively using the PROMIS Pain Intensity survey

Assess patient pain intensity postoperatively

Assess pain interference at 1 year postoperatively using the PROMIS Pain Interference survey

Assess pain interference postoperatively

Assess physical functioning at 1 year postoperatively using the PROMIS Physical Functioning Survey

Assess physical functioning postoperatively

Assess quality of life at 1 year postoperatively using the HerQLes survey

Assess quality of life postoperatively

Assess hernia recurrence at 30 days postoperatively

Assess bulge at 30 days postoperatively

Assess Surgical Site Occurrences at 30 days

Assess Surgical Site Occurrences at 30 days postoperatively

Assess hernia recurrence at 1 year postoperatively

Assess bulge at 1 year postoperatively

Assess Surgical Site Occurrences at 1 year postoperatively

Assess overall complications at 30 days postoperatively

Assess overall complications at 1 year postoperatively

Abdominal wall reconstruction with XenMatrix

XenMatrix

Benjamin Sarac, MD

Jeffrey E Janis, MD

Daniel S Eiferman, MD

Vimal Narula, MD

The purpose of the study is to compare the clinical outcomes of two commonly used, FDA-approved biologic meshes in hernia repair and abdominal wall reconstruction (Strattice and XenMatrix). The two meshes are derived from pig skin from which cells have been removed and which have been sterilized. The two meshes are made by two different companies using different processes.

This is a prospective, randomized-controlled trial comparing two porcine acellular matrices in abdominal wall reconstruction. It is single-blind (patients are blinded to the type of mesh used while surgeons are not).

Our goals in this study are:

1. PRIMARY OUTCOME: To compare the overall complication rates between two non-cross-linked porcine dermal matrices (XenMatrix and Strattice) at 30 days and 1 year postoperatively
2. SECONDARY OUTCOMES

i. To compare the rate of Surgical Site Occurrences (SSOs) between XenMatrix and Strattice in abdominal wall reconstruction at 30 days and 1 year postoperatively

1. Infection
2. Seroma
3. Hematoma
4. Wound dehiscence
5. Skin necrosis
6. Formation of enterocutaneous fistula
7. Mesh infection ii. To compare the hernia recurrence rate between XenMatrix and Strattice at 30 days and 1 year postoperatively iii. To compare the bulge rate between XenMatrix and Strattice at 30 days and 1 year postoperatively iv. To compare to changes in patient pain, physical functioning and quality of life after hernia repair between XenMatrix and Strattice, preoperatively, and at 1 year postoperatively A. Pain assessment: Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity survey, PROMIS Pain Interference survey B. Physical functioning assessment: PROMIS Physical Function C. Quality of life assessment: Hernia-Related Quality-of-Life (HerQLes) survey

RCT of Two Noncrosslinked Porcine Acellular Dermal Matrices in Ab Wall Reconstruction

Prospective Trial Comparing the Performance Profiles of Two Non-Cross-Linked Porcine Dermal Matrices in Abdominal Wall Reconstruction

Compare the overall complication rates between two non-cross-linked porcine dermal matrices (XenMatrix and Strattice) at 1 year postoperatively

Compare the rate of Surgical Site Occurrences (SSOs) between XenMatrix and Strattice in abdominal wall reconstruction at 1 year postoperatively. These include:

1. Infection
2. Seroma
3. Hematoma
4. Wound dehiscence
5. Skin necrosis
6. Formation of enterocutaneous fistula
7. Mesh infection

Compare the overall complication rates between two non-cross-linked porcine dermal matrices (XenMatrix and Strattice) at 30 days postoperatively

Compare the rate of Surgical Site Occurrences (SSOs) between XenMatrix and Strattice in abdominal wall reconstruction at 30 days postoperatively. These include:

1. Infection
2. Seroma
3. Hematoma
4. Wound dehiscence
5. Skin necrosis
6. Formation of enterocutaneous fistula
7. Mesh infection

Measure patient pain intensity of the two groups (XenMatrix and Strattice), at the last office visit before surgery (average of 1-3 weeks before surgery), using the PROMIS Pain Intensity survey

Measure patient pain interference of the two groups (XenMatrix and Strattice), at the last office visit before surgery (average of 1-3 weeks before surgery), using the PROMIS Pain Interference survey

Measure patient pain intensity of the two groups (XenMatrix and Strattice), at 1 year postoperatively, using the PROMIS Pain Intensity survey

Measure patient pain interference of the two groups (XenMatrix and Strattice), at 1 year postoperatively, using the PROMIS Pain Interference survey

Measure physical functioning of the two groups (XenMatrix and Strattice), at the last office visit before surgery (average of 1-3 weeks before surgery), using the PROMIS Physical Function survey

Measure physical functioning of the two groups (XenMatrix and Strattice), at 1 year postoperatively, using the PROMIS Physical Function survey

Measure patient quality of life of the two groups (XenMatrix and Strattice), at the last office visit before surgery (average of 1-3 weeks before surgery), using the HerQLes survey (Hernia Related Quality of Life survey)

Measure patient quality of life of the two groups (XenMatrix and Strattice), at 1 year postoperatively, using the HerQLes survey (Hernia Related Quality of Life survey)

Jeffrey Janis

Professor of Plastic Surgery, Vice-Chairman

Breast Neoplasms

Breast Diseases

Skin Diseases

Implant based Breast Reconstruction with ADM. Both arms will undergo skin or nipple sparing mastectomy and immediate breast reconstruction with implants. Patients in group B with ADM and partial submuscular coverage.

Breast reconstruction without ADM. Both arms will undergo skin or nipple sparing mastectomy and immediate breast reconstruction with implant. Patients in group B will be reconstructed with implant and total submuscular coverage.

If the patient wishes to undergo immediate implant based reconstruction, and meets the selection criteria for entering the study, she is randomly selected to be treated according to Group A or Group B. Group A (no intervention) will be reconstructed with expander or anatomical gel implant without ADM, using complete muscle coverage. Group B (Intervention) will be reconstructed with expander or anatomical gel implant using partial muscle coverage in conjunction with ADM.

Reconstruction with ADM.

Mastectomy for invasive or pre-invasive breast cancer

Skin or nipple sparing mastectomy

Immediate breast reconstruction with implant

Reconstruction with implant

Implant based breast reconstruction with total submuscular coverage

Total submuscular coverage

Implant based breast reconstruction with partial submuscular coverage

Partial submuscular coverage

Fredrik Lohmander, MD

To evaluate breast reconstruction with implants using biological mesh (Strattice™) in the setting of breast cancer treatment.

OBJECTIVES: To evaluate the outcome of immediate breast reconstruction with Acellular Dermal Matrix (Strattice™), measuring safety, effectiveness, and costs. The primary outcome measure is number of unplanned surgical procedures.

STUDY DESIGN: A prospective randomized multicenter trial. One hundred and twenty patients with breast cancer will be enrolled into the study. Study duration will be two years from time of primary cancer surgery.

TRIAL DESIGN This is a randomized controlled multicenter trial, comparing IBR without (group A) and with (group B) the use of ADM. Participants eligible for the study are patients with breast cancer, planned for mastectomy, who wishes IBR with implants. Each participant is individually randomized to either be reconstructed using implants with total submuscular coverage (A) or reconstruction with ADM and partial muscle coverage (B).

Method of assigning patients to treatment groups:

After signing and dating the informed consent the patient is entered into the study. If all inclusion and none of the exclusion criteria are full filled, the patient will be randomized to group A or group B.

TREATMENT/ INTERVENTION The decision and treatment plan advocating mastectomy is based on multi disciplinary conference (MDT), and the diagnosis of invasive or pre-invasive (in situ) breast cancer is made on triple assessment. If the patient wishes to undergo immediate implant based reconstruction, and meets the selection criteria for entering the study, she is randomly selected to be treated according to Group A or Group B. Group A will be reconstructed with expander or anatomical gel implant without ADM, using complete muscle coverage. Group B will be reconstructed with expander or anatomical gel implant using partial muscle coverage in conjunction with ADM.

Randomization at enrollment is made with regard to the use of ADM or not, so both expander and direct-to-implant techniques will be utilized in both groups, depending on the quality of skin flaps at time of surgery.

RANDOMIZATION TYPE Patients will be allocated to treatment according to permuted block technique. The actual randomization will be performed using computer based system located at Regional Cancer Center (RCC) within Karolinska Institutet. In this system inclusion and exclusion criteria will be automatically checked before patients are randomized to treatment. The randomization process will be stratified for the participating units.

STATISTICAL METHODS The main endpoint to be analyzed is the proportion of unplanned reoperations after the initial breast reconstruction. The difference in proportions between the two groups will be presented as a difference in proportion together with a 95% confidence interval. Differences will be tested using Fishers Exact Test. Logistic regression will be used to take into account possible confounding factors.

STUDY MANAGEMENT Data recording: The investigators will ensure that all data from patient visits are entered promptly in ink, in the case report forms (CRF). The principal investigator must sign the final CRF page to attest to the accuracy and completeness of the data. The data from the CRFs are then transferred to a database.

Monitoring and audit: At periods not exceeding 3 months, centers will be contacted to discuss the progress of the trial, with the purpose to verify CRF data against source records for accuracy of data recording and collection.

Breast Reconstruction With Acellular Dermal Matrix in the Setting of Breast Cancer Treatment

Immediate Breast Reconstruction With or Without the Use of Acellular Dermal Matrix: A Randomized Controlled Multicenter Study

Follow-up time after primary surgery is 24 months.

To measure aesthetic outcome between the two study groups using a 6- point scale. The evaluation will be done by three independent groups consisting of lay people, professionals (breast/ plastic surgeons) and patient evaluation. The aesthetic evaluation will be based on the pre and postoperative photos.

To measure any difference between the two study groups in complication rates.

To compare the total number of surgical procedures (planned or unplanned) between the two study groups).

A cost-benefit analysis comparing the cost for an IBR with implant without ADM, vs. IBR with ADM (Strattice™) during a 24 months follow-up time.

Measure Quality of Life in both groups, using the EORTC QLQ-C30 (Generic tool), EORTC-BR23 (Breast cancer specific tool), EORTC-BRR (Specific for breast reconstruction).

Karolinska Institutet

LifeCell

Fredrik Lohmander MD

Women having immediate breast reconstruction with partial or total Strattice cover

Women having immediate implant based breast reconstruction where no Strattice has been used

Implant based reconstruction with strattice cover of part or all of implant

Richard Johnson

Approximately 4,000 women undergo a mastectomy for breast cancer each year in the UK and around 1,500 will have an immediate breast reconstruction. Approximately half of these ladies will have an implant-based breast reconstruction, of which many have an "implant-assisted" breast reconstruction with an Acellular Dermal Matrix.

Strattice™ is an Acellular Dermal Matrix (a pig skin product) made by Acelity. It is used to cover and disguise the lower part of the breast implant. Acellular Dermal Matrices have only been widely used for the last eight years and long-term outcomes for women who have had this form of reconstruction are lacking. Despite this, it is one of the most commonly offered methods of breast reconstruction in the UK for both ladies with a diagnosis of breast cancer and in the risk-reduction setting.

The objective of this study is to assess long-term outcomes of Strattice™-based breast reconstructions in multiple Breast Surgery Centres across the UK. This will be a case-control study comparing women who have had an immediate implant-based breast reconstruction with Strattice™ (case) or without (control). This will be achieved by review and analysis of retrospective data from patients who have undergone immediate breast reconstruction using implants with or without Strattice™ following either a diagnosis breast cancer or for risk-reduction. In addition there will be a prospective clinical assessment of the reconstruction outcomes. Outcomes assessed will include complications, surgical re-interventions and aesthetic results. These will be related to co-morbid conditions and other risk factors. Data will also be collected on unplanned interventions associated with a cost, if available.

Primary Outcome The primary outcome measure will be unexpected loss of the implant.

Secondary Outcomes

To investigate short and long-term outcomes with Strattice™ including:

* Quality of Life
* In-patient treatment costs
* Ipsilateral Revision rates
* Aesthetic outcome
* Breast reconstruction softness (Tonometry)
* Regional pain
* Loco-regional recurrence
* Effect of radiotherapy
* Complications - (seroma drainage, skin necrosis/ wound breakdown)

Study Design

* All patients who have had an immediate implant-based breast reconstruction will be identified from prospective databases.
* Patients will be invited to enter the research study by post. The invitation letter will include: an offer to take part in the study, a Patient Information Leaflet, a Stamped addressed envelope and an Accept/Decline outcome form.
* If they fail to respond, patients will be re-contacted on one further occasion, in the same manner, after approximately two months.
* Patients will be invited to attend a clinical appointment at the Breast Surgery Centre where their reconstruction was performed. Here they will see a clinical researcher in the presence of a clinic nurse and consent to participate in the study.
* Patients will be asked to undergo a clinical assessment, Tonometry (measurement of breast reconstruction softness) and medical photography. The data obtained from this will be anonymised and inputted into a database for analysis.
* Patients will receive a postal questionnaire following the clinic visit asking them about the "Patient Reported Outcomes" of their reconstruction. (This will not be performed at the clinic visit in an attempt to avoid bias). They will receive a further follow-up questionnaire 12 months later.
* The medical records of patients will be reviewed to assess outcomes including complications from surgery.
* If a patient does not consent for the prospective part of the study, a retrospective audit of their notes for implant loss, revisions and complications will be performed
* All data will be collected on Case Report Forms. Study numbers will be allocated, and linked-anonymised data inputted into a database on a NHS computer for analysis.
* Medical records, including clinic letters, nursing records and anaesthetic charts will be reviewed to collect data on:

  * Patient demographics (age, BMI, comorbidities and smoking history at time of surgery)
  * Surgical details (operation type, operation time, mastectomy weight, implant size/type)
  * Details on cancer outcome and adjuvant therapies
  * Post-operative complications (including need for reoperation, prolonged healing, loss of implant)
* Additional prospective data analysed will include:

  * Patient Reported Outcome questionnaire results
  * Tonometry (breast softness)
  * Baker Capsular Contracture grade
  * Aesthetic outcome (using Likert score) This will be assessed by the clinical researcher, and independently assessed using the medical photographs, with the assessor blinded to the reconstruction technique

Assessment of Contracture Using the Baker Breast Contracture Scale, the researcher will assess the Baker Grade for each breast to assess the level of capsular contracture.

Baker Grade Parameters I the breast is normally soft and looks natural II the breast is a little firm but looks normal III the breast is firm and looks abnormal IV the breast is hard, painful, and looks abnormal

Inclusion Criteria

* Patients age 18 years or older at the time of surgery.
* Patients who have undergone immediate Implant-based breast reconstruction with or without Strattice™ with a minimum follow-up of six months.
* Patients capable of providing informed consent.

Exclusion Criteria

* Patients who have had an immediate implant-based breast reconstruction with an alternative brand of matrix/mesh to Strattice™.
* Patients who have had a flap based-reconstruction with implant.
* Delayed reconstructions.

Study Size and Statistical Analysis

* From three large breast units across the UK, we shall aim to recruit a maximum of 400 patients to the prospective part of the study.
* Statistical Analysis will be performed in collaboration with Dr Julie Morris, Honorary Senior Lecturer, Department of Medical Statistics. SPSS 15 will be used to analyse the data.

Study Sites:

University Hospital of South Manchester Newcastle Upon Tyne Hospitals NHS Trust Bradford Teaching Hospitals NHS Foundation Trust

Breast Reconstruction Outcomes With and Without StratticE

Breast Reconstruction Outcomes With and Without StratticE (BROWSE)

Patients will be recorded as to whether they have or have not received radiotherapy. Effect of radiotherapy on the primary and secondary outcome measures will be compared between and within groups

Cosmesis domains of Breast-Q quality of life questionnaire and likert 1-5 scale

Using tonometric measurement of breast softness

Using pain domain of Breast-Q Quality of Life questionnaire

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Perineal Reconstruction Following eLAPE and Simultaneous Stoma Sublay Reinforcement	NCT01670851	Rectal Cancer	Strattice	18 Years -	University Hospitals, Leicester
RCT of Two Noncrosslinked Porcine Acellular Dermal Matrices in Ab Wall Reconstruction	NCT02228889	Hernia, Ventral Intestinal Fist... Fibromatosis, A...	Abdominal wall ... Assess pain int... Assess pain int... Assess physical... Assess patient ... Assess patient ... Assess pain int... Assess physical... Assess quality ... Assess hernia r... Assess bulge at... Assess Surgical... Assess hernia r... Assess bulge at... Assess Surgical... Assess overall ... Assess overall ... Abdominal wall ... Strattice XenMatrix	18 Years - 99 Years	Ohio State University
Breast Reconstruction With Acellular Dermal Matrix in the Setting of Breast Cancer Treatment	NCT02061527	Breast Cancer	Reconstruction ... Skin or nipple ... Reconstruction ... Total submuscul... Partial submusc...	18 Years -	Karolinska University Hospital
RCT of Two Noncrosslinked Porcine Acellular Dermal Matrices in Ab Wall Reconstruction	NCT02228889	Hernia, Ventral Intestinal Fist... Fibromatosis, A...	Abdominal wall ... Assess pain int... Assess pain int... Assess physical... Assess patient ... Assess patient ... Assess pain int... Assess physical... Assess quality ... Assess hernia r... Assess bulge at... Assess Surgical... Assess hernia r... Assess bulge at... Assess Surgical... Assess overall ... Assess overall ... Abdominal wall ... Strattice XenMatrix	18 Years - 99 Years	Ohio State University
Breast Reconstruction Outcomes With and Without StratticE	NCT02608593	Breast Neoplasm...	Strattice	18 Years -	Manchester University NHS Foundation Trust

Spots Global Cancer Trial Database for strattice

Every month we try and update this database with for strattice cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for strattice

Every month we try and update this database with for strattice cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for strattice cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.