Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

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

Gastrointestinal Diseases

Intestinal Diseases

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

Strattice

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)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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
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

Spots Global Cancer Trial Database for assess surgical site occurrences at 1 year postoperatively