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

NACompletedINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

January 31, 2015

Primary Completion Date

March 27, 2025

Study Completion Date

March 27, 2025

Conditions
Hernia, VentralIntestinal FistulaFibromatosis, Abdominal
Interventions
PROCEDURE

Abdominal wall reconstruction with Strattice

Abdominal wall reconstruction using Strattice

OTHER

Assess pain intensity at last office visit preoperatively

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

OTHER

Assess pain interference at last office visit preoperatively

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

OTHER

Assess physical functioning at last office visit preoperatively

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

OTHER

Assess patient quality of life at last office visit preoperatively

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

OTHER

Assess patient pain intensity postoperatively

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

OTHER

Assess pain interference postoperatively

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

OTHER

Assess physical functioning postoperatively

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

OTHER

Assess quality of life postoperatively

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

OTHER

Assess hernia recurrence at 30 days postoperatively

Assess hernia recurrence at 30 days

OTHER

Assess bulge at 30 days postoperatively

Assess bulge at 30 days

OTHER

Assess Surgical Site Occurrences at 30 days postoperatively

Assess Surgical Site Occurrences at 30 days

OTHER

Assess hernia recurrence at 1 year postoperatively

Assess hernia recurrence at 1 year postoperatively

OTHER

Assess bulge at 1 year postoperatively

Assess bulge at 1 year postoperatively

OTHER

Assess Surgical Site Occurrences at 1 year postoperatively

Assess Surgical Site Occurrences at 1 year postoperatively

OTHER

Assess overall complications at 30 days postoperatively

OTHER

Assess overall complications at 1 year postoperatively

PROCEDURE

Abdominal wall reconstruction with XenMatrix

Abdominal wall reconstruction with XenMatrix

DEVICE

Strattice

Strattice mesh

DEVICE

XenMatrix

Xenmatrix mesh

Trial Locations (1)

43210

The Ohio State University Wexner Medical Center, Columbus

All Listed Sponsors
lead

Jeffrey Janis

OTHER

NCT02228889 - RCT of Two Noncrosslinked Porcine Acellular Dermal Matrices in Ab Wall Reconstruction | Biotech Hunter | Biotech Hunter