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Christina M.

Scifre MD et al

SUPPLEMENTAL OXYGEN FOR THE PREVENTION OF POSTCESAREAN INFECTIOUS MORBIDITY: A RANDOMIZED CONTROLLED TRIAL

Background
 Perioperative oxygen therapy could reduce the

risk of postoperative infection  Oxidative killing mechanism for the bactericidal activity of neutrophils depend on the propduction of bactericidal superoxide radicals from molecular oxygen  Leukocyte ba cteial killing capacity is impaired at the low oxygen tension often found in wounds and perioperative arterial  Wound oxygen tension can be increased by a higher fraction of inspired O2 (FiO2)

Objective
 to investigate whether supplemental oxygen during and for 2 hours after cesarean delivery reduces the incidence of postcesarean infectious morbidity

Objective
 Primar outcome measure: SSI wound infection & endometritis  Hypothesis: supplying 10L of O2 by face mask during & for 2 hours after CS would reduce the frequency of surgical site infection

Method
 Randomized controlled trial of supplemental oxygen for the prevention of postcesarean delivery infectious morbidity at Washington University in St. Louis, MO  Institutional review board approval was obtained before patient enrollment, and written informed consent was obtained from all participants.

Method
 INCLUSION:
underwent scheduled or intrapartum cesarean delivery with regional anesthesia

 EXCLUSION:
Emergency surgery in which the participant was unable to provide informed consent, HIV, chronic CST Other immunosuppressive therapy, general anesthesia, and a diagnosis of extrauterine infection (ie, pyelonephritis or pneumonia) before cesarean delivery. Patients who unexpectedly required GA/ delivered vaginally after randomization

Method
 Written consent obtained  Random assignment of patients in a 1:1 scheme (supplemental O2 group: standard care group)  Randomization achieved with opaque envelopes that contained the assigned study group opened after the patients had agreed to participate in the study before the surgery

Method
 SUPPLEMENTAL O2

GRP
O2 at 10 L/min (FiO2 of 80%) by nonbreather mask during and after CS Assessed by an anesthesiologist and by the postpartum nurse at 30, 60, 90, 120 minutes after surgery

 STANDARD CARE

GROUP
O2 at 2 L/min (FiO2 of 25-20%) by nasal cannula during the CS delivery only

O2 sat was assessed both intraop and postop for both groups If with O2 sat of <95% supplemental O2 supplied

Method
 Standard preop skin prep and prophylatic   

anbtibiotics were given to both groups Cefazolin as primary preop prophylaxis Clindamycin used for patients with penicillin allergy Subq depth was measured by the primary operative team with sterile ruler; demographic intrapartum and operative information was abstracted from the medical records Operative decision to place subq sutures was left to the surgical team

Method
 Diagnostic criteria for infectious outcome

(endometritis)
Oral temp >38 C after the first 24 hrs ffg the procedure Fundal or lower abdominal tenderness greater than expected Foul smelling/ purulent lochia

 Endometritis was diagnosed only if other causes

for the patient s signs & symptoms were not identified  Treated with IV antibiotics

Method
 Diagnostic criteria for infectious outcome (wound infection)
Wound opening >1 cm or other surgical intervention (lap, debdridement) Plus (at least 1 of the ffg)
Purulent drainage from the wound Erythema or induration of the surrounding tissues Maternal oral temp >38 C Radiographic evidence of infection

Method
 Pre-identified secondary outcomes:
Wound opening >1cm because of wound hematoma or seroma Hospital readmission Need for IV antibiotics after the first 24 hours after the procedure

Method
 Medical records reviewed at the time of the 2-4 week postop visit
If unable to return telephone inquiry by research nurse Data collection form was used as prompt during the telephone interviews to ensure standardization

Method
 Primary comparison of the study was supplemental O2 vs standard care with respect to primary outcome of infectious morbidity  Data was analyzed using unpaired t tests for normally distributed continous variables, Mann-Whitney U test for normally distributed continous variables, Chi-squared/ Fisher s exact tests for categoric data

Method
 P value of <0.05 = significant  The study protocol included a continous (daily) process of monitoring and reporting of maternal and neonatal adverse events  Initial sample size estimation of the rate of infectious morbidity (556 606)

Results
 Feb 2008 Mar 2010
21 were excluded
13 GA 6 vaginal delivery 1 extrauterine infection 1 prev enrolled in a conflicting study

7 were in the standard care group 14 were in the supplemental O2 group

Results
 585 were included in the final analysis
535 (91.5%) received their alloted study treatment 6 (2.1%) lost to follow up 63/297 (21.2%) standard care group = 70/ 288 (24.3) supplemental O2 group = telephone interview Additional O2 to maintain O2 sat of 95% was required in 18 subjects

FIGURE Trial recruitment and flow NC, nasal cannula; NRBM, non-rebreather mask. Scifres. Supplemental oxygen for the prevention of postcesarean infection. Am J Obstet Gynecol 2011.

Results
 Similarity of study groups were observed in terms of large nuber of clinical variables: maternal age, AOG at delivery, BMI, subq depth, maternal DM, Grp B strep perineal colonization, surgical blood loss, prophylactic antibiotic use, timing of administration of antibiotics

Variable Maternal age, y a Gravity, n a Gestational age, wk Race, n (%) White Black Other Insurance, n (%) Public Private None Smoking, n (%) Illicit drug use, n (%) Preterm delivery, n (%) <37 wk <32 wk Body mass index at delivery, n (%) Normal 2 Overweight (>25 kg/m ) Obese (>30 kg/m ) Subcutaneous depth, a cm Chronic hypertension, n (%) TABLE 1 Characteristics of participants by study assignment
2 a

Standard care (n = 297) 27.85.9 3.11.8 37.82.5 92(30.1) 186(62.6) 19(6.4) 190(64.0) 91(30.6) 16(5.4) 50(16.8) 12(4) 56(18.9) 9(3.3)

Supplemental oxygen (n P value = 288) 27.56.4 3.01.7 37.53.2 93(32.3) 176(61.1) 19(6.6)

.48 .23 .18 .93

.65 190(66.0) 87(30.2) 11(3.8) 37(12.9) 11(3.8) 56(19.4) 20(6.9)

.18 .89 .87 .03 .13

24(8.1) 43(14.5) 230(77.44) 2.611.58 21(7.1)

20(6.9) 60(20.8) 208(72.22) 2.671.50 34(11.8) .63 .05

Pregnancy-induced hypertension, n (%) Diabetes mellitus, n (%) Pregestational Gestational Asthma, n (%) Previous abdominal surgery that included cesarean section, laparoscopy, laparotomy, n (%) Preoperative a hemoglobin, g/dL Multiple gestation, n (%) Singleton Twin Triplet Labor before cesarean delivery, n (%) a Hours in labor Group B streptococcuspositive, n (%) Yes No Unknown

43(14.5)

57(19.8)

.09

13(4.4) 19(6.4) 51(17.2) 210(70.7)

17(5.9) 20(6.9) 38(13.2) 181(62.9)

.40 .79 .18 .04

11.51.45

11.41.37

.66 .35

276(92.93) 21(7.1) 0 97(32.7) 16.48.5

260(92.6) 27(9.4) 1(0.4) 115(40.0) 14.59.6

.07 .50 .99

68(22.9) 238(46.5)

67(23.3) 132(45.8)

TABLE 1 Characteristics of participants by study assignment

Results
 Infectious morbidity developed ibn 10.4% of participants (8.8% in standard care group; 12.2% in supplemental O2 group  No significant difference in incidence of wound nfection or endometritis  No difference in wound complication or hospital readmission rate