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