Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02666365
Other study ID # STUDY00003845
Secondary ID
Status Withdrawn
Phase Phase 4
First received
Last updated
Start date March 2018
Est. completion date June 2019

Study information

Verified date May 2018
Source Milton S. Hershey Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Patients undergoing an elective ventral hernia repair will be randomly assigned to receive either bolus infusion or continuous infusion of the cefazolin as the prophylactic antibiotic. The blood concentrations of unbound cefazolin would be measured in their blood samples and the levels compared within the two groups with respect to their minimal inhibitory concentration (MIC) value.


Description:

Patients who will be undergoing elective ventral hernia repair will be potential candidates for this study. Once identified, the surgical team will approach the participant for consent and inclusion in the study. On the day of surgery, the subjects will be assigned to either the Bolus Group (CB) or Continuous Infusion Group (CI) according to a randomly generated assignment procedure. During the procedure, the dose of prophylactic Cefazolin will be given an hour before surgery and will be administered in accordance to group assignment. Subjects in the CB will receive bolus infusions of Cefazolin every 4 hours till the end of surgery. Subjects in the CI group will receive an initial bolus injection of Cefazolin followed by a continuous infusion till the closure of skin incision. Blood samples will be taken during surgery at t=0, 15, 30 and 60 minutes and every hour following till the end of surgery or 6 hours (whichever comes sooner)


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date June 2019
Est. primary completion date March 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age >18 years

- Elective open Ventral hernia repair in CDC class one (clean) cases

- Planned operative time greater than 4 Hours

- Planned routine administration of cefazolin for pre-op prophylaxis

- No history of MRSA

Exclusion Criteria:

- Patients unable to give informed consent

- Allergy to cephalosporins

- Pre-existing documented infection or ostomy (class II-IV wounds)

- Received cefazolin within 24 hours before surgery

- Creatinine clearance < 30 ml/min

- Upstaging of wound class intra-op that results in the administration of additional antibiotics

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Bolus infusion of Cefazolin
Subjects in the bolus infusion arm of the study will receive bolus infusions of cefazolin throughout the surgical procedure
Continuous infusion of Cefazolin
Subjects in the continuous infusion arm of the study will receive a continuous infusion of the cefazolin throughout the surgical procedure

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Milton S. Hershey Medical Center

References & Publications (14)

Adembri C, Ristori R, Chelazzi C, Arrigucci S, Cassetta MI, De Gaudio AR, Novelli A. Cefazolin bolus and continuous administration for elective cardiac surgery: improved pharmacokinetic and pharmacodynamic parameters. J Thorac Cardiovasc Surg. 2010 Aug;140(2):471-5. doi: 10.1016/j.jtcvs.2010.03.038. Epub 2010 Jun 8. — View Citation

Blatnik JA, Krpata DM, Novitsky YW, Rosen MJ. Does a history of wound infection predict postoperative surgical site infection after ventral hernia repair? Am J Surg. 2012 Mar;203(3):370-4; discussion 374. doi: 10.1016/j.amjsurg.2011.12.001. — View Citation

Bratzler DW, Dellinger EP, Olsen KM, Perl TM, Auwaerter PG, Bolon MK, Fish DN, Napolitano LM, Sawyer RG, Slain D, Steinberg JP, Weinstein RA; American Society of Health-System Pharmacists (ASHP); Infectious Diseases Society of America (IDSA); Surgical Infection Society (SIS); Society for Healthcare Epidemiology of America (SHEA). Clinical practice guidelines for antimicrobial prophylaxis in surgery. Surg Infect (Larchmt). 2013 Feb;14(1):73-156. doi: 10.1089/sur.2013.9999. Epub 2013 Mar 5. — View Citation

Buijk SE, Gyssens IC, Mouton JW, Metselaar HJ, Groenland TH, Verbrugh HA, Bruining HA. Perioperative pharmacokinetics of cefotaxime in serum and bile during continuous and intermittent infusion in liver transplant patients. J Antimicrob Chemother. 2004 Jul;54(1):199-205. Epub 2004 Jun 2. — View Citation

Dunne JR, Malone DL, Tracy JK, Napolitano LM. Abdominal wall hernias: risk factors for infection and resource utilization. J Surg Res. 2003 May 1;111(1):78-84. — View Citation

Ferraz ÁA, Siqueira LT, Campos JM, Araújo GC, Martins Filho ED, Ferraz EM. ANTIBIOTIC PROPHYLAXIS IN BARIATRIC SURGERY: a continuous infusion of cefazolin versus ampicillin/sulbactam and ertapenem. Arq Gastroenterol. 2015 Apr-Jun;52(2):83-7. doi: 10.1590/S0004-28032015000200002. — View Citation

Finan KR, Vick CC, Kiefe CI, Neumayer L, Hawn MT. Predictors of wound infection in ventral hernia repair. Am J Surg. 2005 Nov;190(5):676-81. — View Citation

Hawn MT, Vick CC, Richman J, Holman W, Deierhoi RJ, Graham LA, Henderson WG, Itani KM. Surgical site infection prevention: time to move beyond the surgical care improvement program. Ann Surg. 2011 Sep;254(3):494-9; discussion 499-501. doi: 10.1097/SLA.0b013e31822c6929. — View Citation

Houck JP, Rypins EB, Sarfeh IJ, Juler GL, Shimoda KJ. Repair of incisional hernia. Surg Gynecol Obstet. 1989 Nov;169(5):397-9. — View Citation

Kaafarani HM, Kaufman D, Reda D, Itani KM. Predictors of surgical site infection in laparoscopic and open ventral incisional herniorrhaphy. J Surg Res. 2010 Oct;163(2):229-34. doi: 10.1016/j.jss.2010.03.019. Epub 2010 Apr 1. — View Citation

Lee FM, Trevino S, Kent-Street E, Sreeramoju P. Antimicrobial prophylaxis may not be the answer: Surgical site infections among patients receiving care per recommended guidelines. Am J Infect Control. 2013 Sep;41(9):799-802. doi: 10.1016/j.ajic.2012.11.021. Epub 2013 Mar 13. — View Citation

MILES AA, MILES EM, BURKE J. The value and duration of defence reactions of the skin to the primary lodgement of bacteria. Br J Exp Pathol. 1957 Feb;38(1):79-96. — View Citation

Stulberg JJ, Delaney CP, Neuhauser DV, Aron DC, Fu P, Koroukian SM. Adherence to surgical care improvement project measures and the association with postoperative infections. JAMA. 2010 Jun 23;303(24):2479-85. doi: 10.1001/jama.2010.841. — View Citation

Trent Magruder J, Grimm JC, Dungan SP, Shah AS, Crow JR, Shoulders BR, Lester L, Barodka V. Continuous Intraoperative Cefazolin Infusion May Reduce Surgical Site Infections During Cardiac Surgical Procedures: A Propensity-Matched Analysis. J Cardiothorac Vasc Anesth. 2015 Dec;29(6):1582-7. doi: 10.1053/j.jvca.2015.03.026. Epub 2015 Mar 31. — View Citation

* Note: There are 14 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Difference in Area Under Curve (AUC) of Cefazolin plasma concentration and minimum inhibitory concentration (MIC) in both treatment arms After blood sample collection is completed samples will be analyzed for plasma concentrations of cefazolin. This concentration will be compared with the standard minimum inhibitory concentration of Cefazolin. It is expected that the difference between AUC and MIC in the continuous infusion group will be higher than the bolus infusion group during the first four hours of surgery. First four hours
Secondary Difference in AUC of plasma concentration between the two regimens for the entire duration of surgery After blood sample collection is completed samples will be analyzed for plasma concentrations of cefazolin. This concentration will be compared with the standard minimum inhibitory concentration of Cefazolin. It is expected that the difference between AUC and MIC in the continuous infusion group will be higher than the bolus infusion group for the entire duration of surgery. Duration of surgery
Secondary Total dose of cefazolin administered during the surgery Duration of surgery
Secondary Total dose of cefazolin administered during the first 24 hours 24 hours after the beginning of surgery
See also
  Status Clinical Trial Phase
Completed NCT04969302 - Examination of the Effect of Skin Antisepsis With Pre-heated Povidone Iodine on Surgical Site Infections: A Quasi-Experimental Study N/A
Completed NCT02253069 - PHMB-based Antiseptic Use in Full-thickness Surgical Wounds N/A
Completed NCT01472549 - The Skin Prep Study N/A
Completed NCT03685604 - PVP Iodine vs Chlorhexidine in Alcohol for Disinfection of the Surgical Site Phase 4
Not yet recruiting NCT02503904 - Tumescent Antibiotic Delivery for Prevention of Surgical Site Infection Phase 2/Phase 3
Completed NCT01888367 - Safety, Efficacy and Tolerability Study of up to 20 mL of DFA-02 in Patients Undergoing Abdominal Surgery Phase 2
Completed NCT02619773 - Effect of Mupirocin Dressings Versus Island Dressings on Surgical Site Infections in Elective Colorectal Surgery N/A
Completed NCT01425697 - Eliminate Risk of Cardiac Surgical Site Events N/A
Terminated NCT02799667 - Do Single Use Negative Pressure Dressings Reduce Wound Complications in Obese Women After Cesarean Delivery N/A
Recruiting NCT02436395 - Povidone-iodine and the Normal Saline Cleaning the Incision for the SSIs N/A
Active, not recruiting NCT03402945 - Prevention of Infections in Cardiac Surgery (PICS) Prevena Study Phase 4
Completed NCT01971138 - Review of Surgical Site Infection Registration Routine at Surgery Departments in Sweden and Validation of One of the Used Routines N/A
Completed NCT01949935 - Efficacy Study of Mupirocin on Infection After Coronary Artery Bypass Grafting Phase 3
Completed NCT01138852 - Ampicillin/Sulbactam Versus Cefuroxime as Antimicrobial Prophylaxis for Cesarean Section Phase 4
Recruiting NCT06378359 - Effectiveness of Screening and Decolonization of S. Aureus to Prevent S. Aureus Surgical Site Infections in Surgery Outpatients
Not yet recruiting NCT02012517 - Antibiotic Prophylaxis in Prosthetic Breast Reconstructions Phase 4
Completed NCT03686553 - St. Barbara Specialised Regional Hospital No. 5: Surveillance of Healthcare-Associated Infections
Completed NCT01916733 - A Quality Initiative to Improve Glycemic Control in Diabetic and Non-Diabetic Insulin Study N/A
Not yet recruiting NCT06043414 - Barbed Suture vs Non-Barbed Closure for Emergency Exploratory Laparotomy RCT N/A
Completed NCT05090657 - Nasal Photodisinfection in All Patients Presenting for Surgery for a Wide Range of Surgical Procedures Phase 2