Infection Clinical Trial
Official title:
The Use of Synthetic Mesh in Contaminated and Infected Abdominal Wall Repairs: Challenging the Dogma of an Absolute Contra-indication. A Long-term Prospective Clinical Trial
Verified date | October 2018 |
Source | University of Sao Paulo General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Background: Abdominal wall reconstruction in patients presenting with enteric fistulas and
mesh infection is challenging. There is a consensus that synthetic mesh must be avoided in
infected operations. The alternatives to using synthetic mesh, such as component separation
techniques and biologic mesh, present disappointing results with expressive wound infection
and hernia recurrence rates.
Methods: A prospective clinical trial designed to evaluate the short and the long-term
outcomes of patients submitted to elective abdominal wall repair with synthetic mesh in the
dirty-infected setting, and compared to a cohort of patients submitted to clean ventral
hernia repairs.
Status | Completed |
Enrollment | 80 |
Est. completion date | February 28, 2018 |
Est. primary completion date | February 28, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
"Inclusion Criterion" - the presence of an active chronic mesh infection "Exclusion Criteria" - giant ventral hernias with a volume ratio higher than 25% and loss of domicile - patients on immunosuppressive therapy or using corticosteroids - patients with hepatic cirrhosis and portal hypertension - Chron´s disease - acute postoperative mesh infection - chronic mesh infections following inguinal hernia repair - emergency operations. |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital das Clinicas da FMUSP | São Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo General Hospital |
Brazil,
Antonopoulos IM, Nahas WC, Mazzucchi E, Piovesan AC, Birolini C, Lucon AM. Is polypropylene mesh safe and effective for repairing infected incisional hernia in renal transplant recipients? Urology. 2005 Oct;66(4):874-7. — View Citation
Birolini C, de Miranda JS, Utiyama EM, Rasslan S. A retrospective review and observations over a 16-year clinical experience on the surgical treatment of chronic mesh infection. What about replacing a synthetic mesh on the infected surgical field? Hernia. 2015 Apr;19(2):239-46. doi: 10.1007/s10029-014-1225-9. Epub 2014 Feb 9. — View Citation
Birolini C, Utiyama EM, Rodrigues AJ Jr, Birolini D. Elective colonic operation and prosthetic repair of incisional hernia: does contamination contraindicate abdominal wall prosthesis use? J Am Coll Surg. 2000 Oct;191(4):366-72. — View Citation
Choi JJ, Palaniappa NC, Dallas KB, Rudich TB, Colon MJ, Divino CM. Use of mesh during ventral hernia repair in clean-contaminated and contaminated cases: outcomes of 33,832 cases. Ann Surg. 2012 Jan;255(1):176-80. doi: 10.1097/SLA.0b013e31822518e6. — View Citation
Franklin ME Jr, Treviño JM, Portillo G, Vela I, Glass JL, González JJ. The use of porcine small intestinal submucosa as a prosthetic material for laparoscopic hernia repair in infected and potentially contaminated fields: long-term follow-up. Surg Endosc. 2008 Sep;22(9):1941-6. doi: 10.1007/s00464-008-0005-y. Epub 2008 Jul 2. — View Citation
Itani KM, Rosen M, Vargo D, Awad SS, Denoto G 3rd, Butler CE; RICH Study Group. Prospective study of single-stage repair of contaminated hernias using a biologic porcine tissue matrix: the RICH Study. Surgery. 2012 Sep;152(3):498-505. doi: 10.1016/j.surg.2012.04.008. Epub 2012 Jul 3. — View Citation
Johnson EK, Tushoski PL. Abdominal wall reconstruction in patients with digestive tract fistulas. Clin Colon Rectal Surg. 2010 Sep;23(3):195-208. doi: 10.1055/s-0030-1262988. — View Citation
Miserez M, Fitzgibbons RJ Jr, Schumpelick V. Hernia surgery and contamination: biological mesh and nothing else? Hernia. 2013 Feb;17(1):1. doi: 10.1007/s10029-013-1044-4. Epub 2013 Jan 17. — View Citation
Rosen MJ, Denoto G, Itani KM, Butler C, Vargo D, Smiell J, Rutan R. Evaluation of surgical outcomes of retro-rectus versus intraperitoneal reinforcement with bio-prosthetic mesh in the repair of contaminated ventral hernias. Hernia. 2013 Feb;17(1):31-5. doi: 10.1007/s10029-012-0909-2. Epub 2012 Mar 14. — View Citation
Rosen MJ, Krpata DM, Ermlich B, Blatnik JA. A 5-year clinical experience with single-staged repairs of infected and contaminated abdominal wall defects utilizing biologic mesh. Ann Surg. 2013 Jun;257(6):991-6. doi: 10.1097/SLA.0b013e3182849871. — View Citation
Szczerba SR, Dumanian GA. Definitive surgical treatment of infected or exposed ventral hernia mesh. Ann Surg. 2003 Mar;237(3):437-41. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Microbiology of mesh infection | a study of the microorganisms causing chronic mesh infection | 30 days | |
Primary | Surgical site occurrence | any surgical infection, wound breakdown, soft tissue ischemia, seroma and hematoma formation | 30 days | |
Secondary | Surgical Site infection | an infection occurring in the part of the body where the surgery took place and further defined as superficial, deep, and organ space | 30 days | |
Secondary | Surgical site occurrence requiring procedural intervention | any wound event requiring opening of the wound, wound debridement, suture excision, percutaneous drainage, hematoma evacuation, or mesh removal | 30 days | |
Secondary | Ventral hernia recurrence | a recurrence of ventral hernia | 36 months | |
Secondary | Mesh infection recurrence | a recurrence of mesh infection | 36 months |
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