The Use of Synthetic Mesh in Contaminated and Infected Abdominal Wall Repairs. A Long-term Prospective Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03702153
• Other study ID #: PPM - Prospective
• Status: Completed
• Phase: N/A
• Start date: January 1, 2012
• Est. completion date: February 28, 2018

Study information

• Verified date: October 2018
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

We designed a prospective study, evaluating the short and the long-term outcomes of the surgical treatment of 40 consecutive patients presenting with an infected abdominal wall, compared to a cohort of 40 patients submitted to clean ventral hernia repairs. Patients were admitted between January 2012 and February 2015, and operated at the Hospital das Clinicas of the University of São Paulo School of Medicine, in Brazil. All patients included in the study group carried an active chronic mesh infection (mesh sinus, exposed mesh or mesh related enteric fistulas) resulting from a previous hernia repair, with or without an associated recurrent ventral hernia. All the operations required in this group were classified as Class IV (dirty-infected), accordingly to the CDC Wound Classifications, as adopted by the European registry for abdominal wall hernias. The only inclusion criterion was the presence of an active chronic mesh infection. The infected abdominal wall (IM) group and the outcomes of the treatment were compared to a clean-control (CC) group of patients who underwent clean abdominal wall reconstructions, originally belonging to a prospective study of the tensiometry of the abdominal wall, and operated during the same period and in the same conditions. The exclusion criteria were: giant ventral hernias with a volume ratio higher than 25%, 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 and emergency operations.The data assessed included gender, age, body mass index (BMI), American Society of Anesthesiologists (ASA) score, comorbidities, smoking status, cancer history, the number of previous abdominal operations, the number of prior hernia operations, the presence of a recurrent incisional hernia and/or enteric fistula and the presentation of the mesh infection. Perioperative data included operative time, anesthesia time, associated procedures, the defect characteristics and the extension of the pre-aponeurotic dissection. Further analysis in the infected mesh (IM) group included the type and position of the infected mesh, the causes for the mesh infection and the microbiology of mesh explants. Patients were followed and operated at the Abdominal Wall and Hernia Repair Unit of the General Surgery and Trauma Discipline, and five surgeons of the team conducted the operations in both groups. Informed consents were presented to the patients in the IM group upon admission. Patients in the CC group signed informed consents to participate the study, during their post-operative follow-up visits.

Surgical procedure The operations were performed through the previous surgical incision. Patients in the IM group had the infected mesh removed completely together with all the sutures, tacks or other foreign material. The surrounding fibrotic tissue and the existing sinus tracts were resected to perform a complete toilet of the abdominal wall. The abdominal cavity was entered in most of the patients, and associated or incidental procedures were made as required. After the removal of the infected mesh, or at the end of the abdominal cavity workup, all the surgical drapes, instruments and gloves were replaced. The size of the defect and the extension of the anterior abdominal wall dissection were estimated. The reconstruction of the midline was done as anatomically as possible, by repositioning of the muscles and primary closure of the aponeurosis. We did not use component separation techniques or transverse abdominal releases in any case. In some patients, a bilateral relaxing incision along the anterior rectus sheath was required to allow the re-approximation of the muscles in the midline. In all patients, a heavyweight macroporous (pore size > 75µm) monofilament polypropylene mesh (Intracorp®, Venkuri, www.venkuri.com.br) was used in the onlay position, to reinforce the repair. The mesh was fixed with multiple absorbable Vicryl® sutures, placed over the borders of the mesh, in the midline and along the relaxing incisions. The remaining dead space between the mesh and the underlying tissue was cleared entirely with interrupted sutures. The operative field was irrigated with 0,9% saline, and the subcutaneous was drained with suction drains. The scars and the exceeding skin flaps were resected. We did not use irrigation with antibiotics solution. The subcutaneous tissue and the skin were closed with interrupted sutures. Fluids and samples of the explanted mesh were sent to cultures and microbiological analysis. The same technique of repair was used in the CC group. The size of the defect was measured, and the extension of the anterior abdominal wall dissection was estimated. A bilateral relaxing incision along the anterior rectus sheath was used routinely in this group, to allow a tensionless closure of the midline.

Outcomes parameters The primary outcomes variables were the presence of any surgical site occurrences (SSO) or surgical site infection (SSI) during the first 30 days after the operation, and the development of hernia recurrence or the recurrence of mesh infection during a 36-month follow-up period. Suspected recurrences of a hernia or infection were determined by physical examination and CT scan imaging. Non-surgical complications, other operations, and deaths were registered during the follow-up period.

Statistical Analysis The chi-square test was conducted to verify the association between categorical variables in contingency tables and the Fisher exact test was adopted in 2x2 tables whenever at least one expected frequency was less than 5. The U-test was used for verifying the association between continuous data and group with two categories, and when normal distribution was observed the Student t-test was performed. The 5% level of significance was considered for all statistical tests. Statistical computer Stata software version 10.0 (StataCorp, College Station, TX) was used for conducting all statistical analysis.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Abdominal Wall Defect
• Abdominal Wall Fistula
• Abdominal Wall Infection
• Communicable Diseases
• Fistula
• Infection

Intervention

Procedure:
• Abdominal wall reconstruction
The repair of abdominal wall defects with polypropylene mesh

Locations

Country	Name	City	State
Brazil	Hospital das Clinicas da FMUSP	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

References & Publications (11)

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

Outcome

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

External Links

•   Clean control group, patients 1 - 40
•   Infected mesh, patients 1 - 10
•   Infected mesh, patients 11 - 20
•   Infected mesh, patients 21 - 30
•   Infected mesh, patients 31 - 40