Infection Clinical Trial
Official title:
Complex Abdominal Wall Reconstruction With Polyvinylidene (PVDF) Mesh in the Setting of Active Infection: a Prospective Case-control Series.
NCT number | NCT05061264 |
Other study ID # | PVDF mesh |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2016 |
Est. completion date | September 2021 |
Verified date | September 2021 |
Source | University of Sao Paulo General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The use of synthetic mesh to repair infected defects of the abdominal wall remains controversial. This study aimed to evaluate the short-term outcomes of using PVDF mesh to treat infected abdominal wall defects in the elective setting.
Status | Completed |
Enrollment | 76 |
Est. completion date | September 2021 |
Est. primary completion date | January 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 86 Years |
Eligibility | Inclusion Criteria: - Study group: patients with the presence of an active chronic mesh infection (non-healing sinus, exposed mesh, or mesh-related enteric fistulas) resulting from a previous repair, or the presence of an enteric/enteroatmospheric fistula, with or without an associated abdominal wall defect - Control group: patients with a primary or recurrent ventral hernia without previous history of infection and eligible for clean operations 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 portal hypertension - patients with 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,
Birolini C, de Miranda JS, Tanaka EY, Utiyama EM, Rasslan S, Birolini D. The use of synthetic mesh in contaminated and infected abdominal wall repairs: challenging the dogma-A long-term prospective clinical trial. Hernia. 2020 Apr;24(2):307-323. doi: 10.1007/s10029-019-02035-2. Epub 2019 Sep 6. — View Citation
Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. — View Citation
Garner JS. CDC guideline for prevention of surgical wound infections, 1985. Supersedes guideline for prevention of surgical wound infections published in 1982. (Originally published in November 1985). Revised. Infect Control. 1986 Mar;7(3):193-200. — View Citation
Haskins IN, Horne CM, Krpata DM, Prabhu AS, Tastaldi L, Perez AJ, Rosenblatt S, Poulose BK, Rosen MJ. A call for standardization of wound events reporting following ventral hernia repair. Hernia. 2018 Oct;22(5):729-736. doi: 10.1007/s10029-018-1748-6. Epub 2018 Feb 10. — View Citation
Hodgkinson JD, Maeda Y, Leo CA, Warusavitarne J, Vaizey CJ. Complex abdominal wall reconstruction in the setting of active infection and contamination: a systematic review of hernia and fistula recurrence rates. Colorectal Dis. 2017 Apr;19(4):319-330. doi — View Citation
Klinge U, Klosterhalfen B, Ottinger AP, Junge K, Schumpelick V. PVDF as a new polymer for the construction of surgical meshes. Biomaterials. 2002 Aug;23(16):3487-93. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Microbiology of mesh infection | the study of the microorganisms causing chronic infection | 30 days | |
Primary | Surgical site occurence | any surgical infection, wound breakdown, soft tissue ischemia, seroma, and hematoma formation | 30 days | |
Primary | Surgical site infection | as an infection occurring where the surgery took place and was further defined as superficial, deep, and organ space | 30 days | |
Secondary | Hernia recurrence | the recurrence of an incisional hernia | 6 and 36 months | |
Secondary | Infection recurrence | the recurrence of a chronic infection, or mesh related infection | 6 and 36 months |
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