Prevention of Cesarean Wound Complications
Brett Einerson, MD MPH2/15/17
Park City, Utah
No disclosures.
Defining “Wound Complication”
Our focus today:Wound infectionWound disruption
Not in focus today:Uterine incisionsOB lacerations
SSI = Surgical Site Infection
Horan. CDC definitions of nosocomial surgical site infections. Infect Control Hosp Epidemiol 1992; 13(10):606–8.
Obesity & Wound Complications
0%
2%
4%
6%
8%
10%
12%
14%
16%
18%
20%
Wound complication Wound infection
BMI<30 BMI 30-45 BMI >45
Stamilio and Scifres. Extreme Obesity and Cesarean Complications. 2014.
The cost.
$3,400 to $4,000 per surgical site infection
$500 millionper year in the U.S.
Olsen. Infect Control Hosp Epidemiol. 2010
So…
How can we prevent wound complications
in patientsundergoing cesarean?
What we do that works.
What we do that works.
• Pre-incision antibiotics
Prophylactic Antibiotic Use and Infectious Morbidity
0%
2%
4%
6%
8%
10%
12%
14%
16%
18%
CompositeInfections
Wound Infections Neonatal Sepsis NICU Admission
No Abx
Abx Cord Clamp
Abx Preop
Smail et al. Cochrane Database 2014.Mackeen et al. Cochrane Database 2014.
NR
*
*
*P<0.05
Reminder: Guidelines for Cesarean
“A single dose of cefazolin before incision.”
• Timing 15-60 min before incision• Dose 2g (3g if ≥120kg)• Redose 4 hrs• Allergy? Clinda 900mg + Gent 5mg/kg• Multi-dose? No
Bratzler. ASHP Report. Am J Healt-Syst Pharm 2013.ACOG Practice Bulletin No 120. 2011.
What we do that works.
• Pre-incision antibiotics• Closure of subcutaneous layer >2cm
Meta-analysis of 6 RCTs (n=875)– No effect when <2cm– But if >2cm…
Chelmow. Meta-analysis. Am J Obstet Gynecol 2004.
Wound complications when subcutaneous tissue ≥2cm deep
0.98
1.03
0.42
0.66
0.1 1 10
Infection
Hematoma
Seroma
Disruption
Risk RatioFavors ClosureFavors Non-closure
Chelmow. Meta-analysis. Am J Obstet Gynecol 2004.
Baseline Risk
14.3%
8.5%
1.6%
7.1%
What we do that works.
• Pre-incision antibiotics• Closure of subcutaneous layer >2cm• Suture the skin (or staple?)
• Meta-analysis (2011)– 5 RCTs + 1 prospective cohort, n=1,487
Skin: Suture vs Staple
Tuuli. Meta-analysis. Staples compared with suture. Obstet Gynecol 2011
Skin: Suture vs Staple• Two newer large RCTs (n=1,114)
– >65% obese
10.6%
14.5%
4.9%5.9%
Mackeen 2014 Figueroa 2013
All Wound Complications
3.7%2.2%2.4%
3.5%
Mackeen 2014 Figueroa 2013
Wound Infection
Staples Sutures**
*P<0.05
What we do that works.
• Pre-incision antibiotics• Closure of subcutaneous layer >2cm• Suture the skin (or staple?)
What we tried that doesn’t work
• Perioperative supplemental oxygen
Three RCTs (total n= 1,559)
1. Gardella: 80% vs 30% O2 stopped early2. Scifres: 10L vs 2L 12% vs 8.8% (P= .18)3. Duggal: 80% vs 30% O2 8.2% vs 8.2% (P= .89)
Gardella. Obstet Gynecol. 2008Scifres. Am J Obstet Gynecol. 2010Duggal. Obstet Gynecol. 2013
No Benefit ? Harm
What we tried that doesn’t work
• Perioperative supplemental oxygen• Routine subcutaneous drainThree Meta-analyses of RCTs agree…
– No benefit in cesarean– No benefit in obese– No benefit in general
Hellums. Am J Obstet Gynecol. 2007Gates. Cochrane Database. 2013Kosins. Plast Reconstr Surg. 2013
What we tried that doesn’t work
• Perioperative supplemental oxygen• Routine subcutaneous drainWhat about in obese cesarean patients?
Multicenter RCTn=280, mean BMI 48, subcut >4cm
Suture Suture+Drain Adj OR (95%CI)
Seroma (%) 9.0 10.6 1.01 (0.44-2.32)
Composite (%) 17.4 22.7 1.21 (0.65-2.26)
Ramsey. Obstet Gynecol. 2005
What we tried that doesn’t work
• Perioperative supplemental oxygen• Routine subcutaneous drain
What’s new and next?
• Skin antisepsis: the debate ends?
Skin Antisepsis (in 2015)• CHX vs Iodophor base +/- alcohol
• Meta-analysis: – 6 low quality RCTs (n=1522)
– No difference in SSI or endometritis
Hadiati. Cochrane Database. 2014Kunkle. J Matern Fetal Neonatal Med. 2015
+++
+CHX
IODC/S
18h
Bact CxPrep
Skin Antisepsis (in 2016)
Skin Antisepsis (in 2016)• Tuuli RCT
n=1147 cesareans
7.3%
2.4%
12.5%
4.0%
1.0%
7.9%
0%
2%
4%
6%
8%
10%
12%
14%
SSI Deep SSI MD Visit
IOD CHX
*
*
*
Skin Antisepsis (in 2017!)
Skin Antisepsis (in 2017!)• Springel RCT (unpublished)
n=932 cesareans
7.0%
5.5%
1.9%
6.3%
4.6%
1.1%
0%
1%
2%
3%
4%
5%
6%
7%
8%
SSI Superficial SSI Readmission
IOD CHX
What’s new?
• Skin antisepsis: the debate ends?• Broad spectrum prophylactic antibiotics
Broad spectrum: Better?
ComplicationCefotetan + doxy +
azithro (n=301)Cefotetan +
placebo (n=296) P
Endometritis (%) 16.9 24.7 .020
Wound infection (%) 0.8 3.6 .030
Postoperative stay (hr) 95 104 .016
23%
3.1%2.1% 1.3%0%
5%
10%
15%
20%
25%
Endometritis Wound Infection
Infection rates over time
1992-1996 (Cephalosporin)
1997-2000 (Trial Extended)
2001-2006 (Routine Extended)
Andrews. RCT. Obstet Gynecol 2003.Tita. Systematic Review. Obstet Gynecol 2009
C/SOAP• Multicenter RCT
MFMUn=2103
• Preop Abx: Cefazolin vs Azithro + Cefazolin
12.0%
6.6%
8.2%
3.4%
6.1%
2.4%
5.0%4.4%
0%
2%
4%
6%
8%
10%
12%
14%
Infection (any) Wound Infxn Readmit/Visit Neonatal Morbidity
*
**
What’s new and next?
• Skin antisepsis: the debate ends?• Broad spectrum prophylactic antibiotics• Dosing of antibiotics (more = better?)
Obesity affects tissue concentration
Toma. Anesth Analg 2011
Pevzner. Obstet Gynecol 2011
2g cefazolin (Ancef)
Cefazolin dosing in Cesarean
0%10%20%30%40%50%60%70%80%90%
100%
Opening Closing
Adequate Tissue Concentration to inhibit
Staphylococcus
P=.35 P=.42
Stitely. Surg Infect 2013Maggio. Obstet Gynecol 2015
0
5
10
15
20
25
30
35
40
Opening Closing
Mean tissue concentration
at incision site (mcg/g)
3g 2g2g 3g4g 2g2g 4g
*P=<0.05
*
*
Prophylactic Oral Dosing
Prophylactic Oral Dosing
16.3% 16.8%
32.8%
6.7%
10.4% 9.8%
SSI Incisional Morbidity SSI (in ROM)
Placebo Azith/Metro
* *
*
Valent RCTn=383mean BMI=40
Oral regimen:
48hrs oralazithro + metro
vs.placebo
What’s up for debate
• Skin antisepsis: the debate ends?• Broad spectrum prophylactic antibiotics• Dosing of antibiotics (more = better?)• Vertical versus transverse (in obese)
Vertical vs Transverse IncisionsWound complications
• No RCTs• Summary of retrospective studies…
Wound complications
Study, Year N BMI Vert Trans OR (95% CI)
Houston, 2000 69 NR NR NR 0.98 (0.18-4.74)
Wall, 2003 239 42 35% 9% 12.4 (3.9-39.3)
Alanis, 2010 194 55 60% 27% 3.4 (0.65-17.20)
Marrs, 2014 3200 46 4.2% 1.7% 0.32 (0.17-0.62)
Negative Pressure Wound Therapy
Cost beneficial for high risk cesarean wounds?
The problem…
There is no cost-effectiveness
without proven effectiveness
Other considerations*
• Normo-glycemia• Normo-thermia (warming)• Pre-op antiseptic shower (CHX)• Clip, don’t shave if removing hair• Hand Scrub:
Alcohol rub >> CHX wash > Iod wash
*Little or conflicting evidence