drugset / Trial / NCT00273377
The Effects of Hypercapnia, Supplemental Oxygen, and Dexamethasone on Surgical Wound Infection
RandomizedFactorialTriple-blindPrevention
Summary
The investigators will test the hypotheses that mild hypercapnia and supplemental oxygen reduce wound infection risk in patients undergoing colon resection. The investigators will simultaneously test the hypothesis that low-dose dexamethasone (a common treatment for postoperative nausea and vomiting) does not increase infection risk.
Timeline
- Start
- 2002-05
- Primary completion
- 2007-12
- Completion
- 2007-12
Outcome
Missed primary endpoint
paper Surgical site infection incidence was similar among groups: 30% oxygen 15.6%, 80% oxygen 15.8% (P=1.00); dexamethasone 15.9%, placebo 15.4%, (P=0.91). PMID 25900659 ↗
paper The SSI rate for normocapnia was 13.3%, and for hypercapnia, it was 11.2% (P=0.29). PMID 23887247 ↗
Publications
- Kurz A, Fleischmann E, Sessler DI, Buggy DJ, Apfel C, Akca O; Factorial Trial Investigators. Effects of supplemental oxygen and dexamethasone on surgical site infection: a factorial randomized trialdouble dagger. Br J Anaesth. 2015 Sep;115(3):434-43. doi: 10.1093/bja/aev062. Epub 2015 Apr 20.
- Akca O, Kurz A, Fleischmann E, Buggy D, Herbst F, Stocchi L, Galandiuk S, Iscoe S, Fisher J, Apfel CC, Sessler DI; Hypercapnia Trial Investigators. Hypercapnia and surgical site infection: a randomized trial. Br J Anaesth. 2013 Nov;111(5):759-67. doi: 10.1093/bja/aet233. Epub 2013 Jul 24.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexamethasone | Small molecule | 4 mg | — |