Search

Prospective, multicenter, single-arm study of antimicrobial-coated, noncrosslinked, acellular porcine dermal matrix (AC-PDM) in a cohort involving all centers for disease control and prevention wound classes in ventral/incisional midline hernia repair (VIHR)., Materials and Methods: Seventy-five patients (mean age 58.6±12.7 years; BMI 31.3±4.9 kg/m 2 ) underwent ventral/incisional midline hernia repair with AC-PDM. Surgical site occurrence (SSO) was assessed in the first 45 days post-implantation. Length of stay, return to work, hernia recurrence, reoperation, quality of life, and SSO were assessed at 1, 3, 6, 12, 18, and 24 months., Results: 14.7% of patients experienced SSO requiring intervention within 45 days post-implantation, and 20.0% thereafter (>45 d post-implantation). Recurrence (5.8%), definitely device-related adverse events (4.0%), and reoperation (10.7%) were low at 24 months; all quality-of-life indicators were significantly improved compared to baseline., Conclusion: AC-PDM exhibited favourable results, including infrequent hernia recurrence and definitely device-related adverse events, with reoperation and SSO comparable to other studies, and significantly improved quality of life., Competing Interests: All conflicts of interest have been declared in the Author Disclosure Form uploaded with this submission and are listed below in a de-identified list without author names to preserve anonymity. Ilahi’s institution received a grant from C. R. Bard, Inc./Davol/Becton Dickinson (BD) to support the work under consideration. Ilahi has no other financial conflicts of interests to disclose relevant to the current study or any other outside work. Velmahos has other financial conflicts of interests to disclose relevant to the current study or any other outside work. Janis’s institution received a grant from C. R. Bard, Inc./Davol/Becton Dickinson (BD) to support the work under consideration. Janis also reports publishing royalties from Thieme and Springer and consulting fees from Allergan/LifeCell. Kovach has no financial conflicts of interests to disclose relevant to the current study. Kovach has received payment for lectures from C. R. Bard, Inc./Davol/Becton Dickinson (BD), W.L. Gore & Associates, and Integra outside the current work. McLean has no financial conflicts of interests to disclose relevant to the current study or any other outside work. Askari’s institution received a grant from C. R. Bard, Inc./Davol/Becton Dickinson (BD) to support the work under consideration. Askari has no other financial conflicts of interests to disclose relevant to any other outside work. Sommer has no financial conflicts of interests to disclose relevant to the current study or any other outside work. Dr. Agarwal’s institution received a grant from C. R. Bard, Inc./Davol/Becton Dickinson (BD) to support the work under consideration. Dr. Agarwal has no other financial conflicts of interests to disclose relevant to the current study or any other outside work. Srinivasan has no financial conflicts of interests to disclose relevant to the current study or any other outside work. Wong has no financial conflicts of interests to disclose relevant to the current study. Wong has received consulting fees (A Cell, Inc.), stock ownership (Lymphagen Corporation), and grants (A Cell, Inc.) outside the current work. Pakula has no financial conflicts of interests to disclose relevant to the current study. Pakula reports consulting fees and speaking fees from Becton Dickinson, Intuitive Surgical, and Medtronic for work outside the current study. Miranda’s institution received a grant from C. R. Bard, Inc./Davol/Becton Dickinson (BD) to support the work under consideration. Miranda also reports consulting fees (RTI Surgical, ReNerve, and Allergan, Abominal Wall Advisory Board) equity interest (Additive Orthopaedics), honoraria/speaking fees (Integra Life Sciences, Candela Corporation, and MiMedx), and patient enrolment bounties (C. R. Bard, Inc./Davol/Becton Dickinson (BD) and Sientra) outside the current work. Stringer has no financial conflicts of interest to disclose relevant to the current study or other outside work. Breen’s institution received a grant from C. R. Bard, Inc./Davol/Becton Dickinson (BD) to support the work under consideration. Breen has no other financial conflicts of interests to disclose relevant to the current study or any other outside work. Shapiro has no financial conflicts of interests to disclose relevant to the current study or any other outside work. McGraw has no financial conflicts of interests to disclose relevant to the current study or any other outside work. Bascone has no financial conflicts of interests to disclose relevant to the current study or any other outside work. Deeken received consulting fees to support manuscript generation for the work under consideration from Becton Dickinson. Deeken reports consulting fees (Becton Dickinson, Ethicon, Medtronic, Osteogenics, Polynovo, Surgical Innovation and Associates, Surgimatrix, TelaBio, and Tissum) for work outside the current study, and ownership/employment (Covalent Bio LLC). Deeken also holds the following issued patents related to hernia-repair materials: 2009293001, 2334257, 2334257UK, 602009046407.8, 2334257FR, 16/043849, 2737542. Martindale’s institution received a grant from C. R. Bard, Inc./Davol/Becton Dickinson (BD) to support the work under consideration. Martindale has no personal financial conflicts of interests to disclose relevant to the current study. Martindale reports consulting fees (Allergan, and Nestle), employment (Oregon Health & Science University), grants, and speakers’ fees (Allergan, Nestle, Fresenius, and Abbott) for work outside the current study., (Copyright © 2023 the Author(s). Published by Wolters Kluwer Health, Inc.)

Objective: The objective of our study was to delineate CT findings and anatomic areas of involvement of surgically proven Fournier gangrene (FG) and determine interobserver reliability., Materials and Methods: This study was a single-center retrospective study of patients with FG who underwent CT before surgical débridement of FG during a 9-year period. Thirty-eight patients with FG, 17 male and 21 female patients, underwent preoperative CT. Two radiologists reviewed the CT studies and recorded findings and anatomic areas of involvement. CT findings were categorized according to a previously described CT scoring system for necrotizing fasciitis and included the presence or absence of fascial air, muscle or fascial edema, fluid tracking, lymphadenopathy, and subcutaneous edema. Cohen kappa was calculated for interobserver reliability., Results: Mean body mass index (BMI [weight in kilograms divided by height in meters squared]) was 42, and 22 of 38 (58%) patients had diabetes. Mean BMI and proportion of patients with diabetes were significantly higher in female patients (mean BMI = 46; 16/21 with diabetes) than male patients (mean BMI = 36; 6/17 with diabetes). CT studies of most patients showed fascial air (36/38 [95%], both readers 1 and 2). Interobserver reliability was substantial to almost perfect for all CT findings except lymphadenopathy, for which it was fair (κ = 0.37). Genital, perineal, and ischiorectal involvement were seen in 87% (33/38), 87% (33/38), and 32% (12/38) of patients for reader 1 and 84% (32/38), 84% (32/38), and 26% (10/38) of patients for reader 2 (κ = 0.29, penis; κ = 0.65, scrotum; κ = 0.91, vulva and labia; κ = 0.68, perineal involvement; κ = 0.80, ischiorectal involvement)., Conclusion: Most CT findings of FG and anatomic areas of involvement showed good interobserver reliability. A high proportion of female patients with FG were observed in this study compared with prior series.