This pilot study is to examine the feasibility of using Permacol Surgical Implant in the repair of abdominal wall defects after removal of infected prosthetic mesh
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
porcine mesh for hernia repair/ abdominal wall reconstruction
University of Kentucky
Lexington, Kentucky, United States
Albany Medical College
Albany, New York, United States
Greenville Hospital System
Greenville, South Carolina, United States
Number of Participants With Hernia Recurrence or Surgical Site Infection Requiring Wound Opening
The primary objective of this study was hernia recurrence or surgical site infection as assessed by a CT scan 12 months following surgery.Hernia recurrence was defined as any abnormal abdominal protrusion, as assessed by 12 month CT. Surgical site infection requiring wound opening was defined as abscess formation or drainage that required surgical wound opening. Wound opening was defined as surgical entry into the wound.
Time frame: 12 months
Subjects Having Permacol Implants Removed or Debrided After Implantation
The secondary objective of this study was the incidence of Permacol™ surgical implant removal or debridement. Removal was defined as complete surgical excision of the implant. Debridement was defined as debridement or lavage of ≥10% of the visible implant surface area as subjectively assessed by the operating surgeon.
Time frame: 12 months
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