drugset / Trial / NCT01194115
Use of 48 Hour Course of Antibiotics to Prevent Surgical Site Infection in Obese Patients Undergoing Cesarean Delivery
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The purpose of this study is to evaluate if preoperative antibiotics, followed by 48 hour course of broad spectrum antibiotics prevents wound infection complications in patients that are obese who undergo cesarean section. Standard antibiotic prophylaxis in all weight women undergoing cesarean section is cefazolin prior to skin incision. It is the hypothesis that a prolonged, 48 hour course of broad spectrum antibiotics that are suited to prevent growth of normal vaginal flora will decrease the rate of surgical site infection in obese patients that are at a greatly increased risk of postoperative infections complications.
Timeline
- Start
- 2010-09
- Primary completion
- 2012-09
- Completion
- —
Publications
- Background Hofmeyr GJ, Smaill FM. WITHDRAWAN. Antibiotic prophylaxis for cesarean section. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD000933. doi: 10.1002/14651858.CD000933.pub2.
- Background Meyer NL, Hosier KV, Scott K, Lipscomb GH. Cefazolin versus cefazolin plus metronidazole for antibiotic prophylaxis at cesarean section. South Med J. 2003 Oct;96(10):992-5. doi: 10.1097/01.SMJ.0000060570.51934.14.
- Background Robinson HE, O'Connell CM, Joseph KS, McLeod NL. Maternal outcomes in pregnancies complicated by obesity. Obstet Gynecol. 2005 Dec;106(6):1357-64. doi: 10.1097/01.AOG.0000188387.88032.41.
- Background Elyan A, Mahran M, el-Maraghy M, Abou-Seeda M. Prophylactic intravenous metronidazole in cesarean section. Chemioterapia. 1984 Feb;3(1):67-70.
- Background Tita AT, Owen J, Stamm AM, Grimes A, Hauth JC, Andrews WW. Impact of extended-spectrum antibiotic prophylaxis on incidence of postcesarean surgical wound infection. Am J Obstet Gynecol. 2008 Sep;199(3):303.e1-3. doi: 10.1016/j.ajog.2008.06.068.
- Valent AM, DeArmond C, Houston JM, Reddy S, Masters HR, Gold A, Boldt M, DeFranco E, Evans AT, Warshak CR. Effect of Post-Cesarean Delivery Oral Cephalexin and Metronidazole on Surgical Site Infection Among Obese Women: A Randomized Clinical Trial. JAMA. 2017 Sep 19;318(11):1026-1034. doi: 10.1001/jama.2017.10567.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CEPHALEXIN ANHYDROUS | Small molecule | 500 mg | Oral |
| Subject | Metronidazole | Small molecule | 500 mg | Oral |
Indications
No indication recorded.