reducing c-section wound complications · complications in high risk patients when using negative...

APRIL 2015

Reducing C-sectionwound complicationsReducing C-sectionwound complications

www.picoincisionmanagement.co.uk

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avoidable bed days over a two year period. Although Caesarean deliveries are

considered to be a clean surgicalprocedure, evidence from recent studiessuggests that the rates of SSI are higherthan might be expected. A recent study,supported by the Health ProtectionAgency, considered post-operativecomplications following 4,107 Caesareandeliveries across 14 hospitals in Englandand Wales (Wloch et al 2012). Theoverall SSI rate was 9.6% while itincreased to 19.8% in women with aBMI>35 and 15.6% in women withdiabetes. These are comparable toinfection rates following dirty surgicalprocedures such as large bowel surgery

Wrightington, Wigan and Leigh NHS Foundation Trust has undertaken a study into the use of a disposable Negative Pressure Wound Therapy (NPWT) system for women with a BMI>35,undergoing Caesarean section deliveries. The results of a 30 month audit are highlighted.

The burden of surgical site infections(SSI) for the NHS is a significant one in both human and financial terms. NICE estimates that 5% of all patientsundergoing surgery will develop a woundinfection, while recent HPA data suggests15.7% of all healthcare-acquiredinfections are post-surgical woundinfection. (HPA 2011) In addition to theburden to patients, these episodesrepresent a significant financial burden to the health service. In a recent clinicaland cost analysis in the Plymouth area,Jenks et al (2014) reviewed the impact of SSI following all surgical procedures to an individual hospital and found thatthey accounted for almost 4,700

Reducing C-sectionwound complications

which has an infection rate of 14.7%(Wloch et al 2012).

A second study from 2011 corroboratesthese findings. Leth et al (2011) in a studyof 2,492 patients, examined the role ofdiabetes and BMI in relation to post Caesarean section wound infection.Patients with a BMI of 30 or more wereconsidered as obese. The infection rate for this group was 23.9% versus 17.5% in the non-obese patient group.

A large scale review of the Pan CelticNetwork examined 22151 Caesareansection procedures to establish the rate of SSI across Scotland, Ireland and Wales(HPS 2008). The cumulative incidence of SSI across the three networks was8.5% (1881 patients in total). Obesity waslinked with increased SSI in all networks(HPS 2008).

It would therefore seem apparent fromthe literature that patients with an elevatedBMI of over 30 undergoing Caesareansection are more likely to develop aninfection than someone who is of normalweight. This is a worrying trend given the increasing rates of obesity which have increased from 50.5% of women in 1993 to 60.4% in 2012 (HSCIC 2014).Importantly, these patients are at risk ofdeveloping significant complications at a time when they should be recovering andbonding with their new baby. Readmissionto hospital for additional care at this timemay increase anxiety both for the patientand their family.

Some commentators have discussedthe nature of the relationship betweenobesity and infection. It is postulated thatwhen operating on patients with excessiveadipose tissue the surgeon may experiencetechnical difficulties when closing thewound due to lack of muscle tone and thethickness of the adipose layer (Irvine andFig1. PICO therapy in situ on a patient post Caesarean section.

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Caesarean section deliveries in womenwith a BMI>35.

MethodIn order to reduce the wound infectionand readmission rates in the patients withBMI of 35 or more, the PICO system wasapplied immediately after the surgicalprocedure, in theatre. PICO is a canister-free, single-use NPWT system for closedsurgical incisions. It has been designed tobe simple to use and to enable the patientto be mobile following surgery – the smalldevice can fit in a patient’s pocket or bag.Each PICO kit includes two dressings andprovides the entire seven day therapy for a patient with no need for additionalcomponents, such as canisters, to managefluid from the incision. The innovativedressing has an airlock layer to ensurenegative pressure is distributed across the dressing and also a silicone woundcontact layer to enable gentle removal of the dressing. With the fluid handlingcapacity of 300mls across both bacteriaproof dressings in the PICO kit, thetherapy will continue to manage andprotect the incision until removal.

In all cases, the NPWT system wasapplied in theatre onto closed wounds,following suturing. PICO therapy wasapplied in theatre immediately followingthe operation and was left in situ for oneweek only. Midwives had undergonewound management training and

were to remain in place for at least 48hours and, if possible, for up to seven days.

In order to reduce the overall infectionrates and prevent readmissions in the highBMI group, a new single-use negativepressure wound therapy system (NPWT)(PICO, Smith and Nephew, Hull) wasimplemented for this patient group. There isan increasing body of evidence to suggestthat NPWT can be effective in reducing therisk of post-operative wound complications,including SSI (Karlakki et al 2014).

Studies in orthopaedic trauma,cardiothoracic, Caesarean section, andhip and knee revision patients havedemonstrated reduced woundcomplications in high risk patients when using negative pressure woundtherapy to manage the incisions (Karlakki et al 2014). One recent study(Harris 2013) from the United States hasidentified that using disposable NPWTas part of a programme to reducecomplications following Caesareansection procedures has had a dramaticeffect on infection rates.

Wrightington, Wigan and Leigh Trustran an initial feasibility study, introducingdisposable NPWT into practice for womenwith BMI>35 undergoing Caesareansection deliveries. The initial experienceon the first fifty patients resulted in noinfections. This paper reports an analysisof the first two years experience of usingPICO disposable NPWT system following

Shaw 2006). The wound is also at risk ifthere is a large pannus or overhangingarea, as may be the case in Caesareansection procedures, which creates frictionand moisture around the wound site.Excessive tension on the incision is alsolikely to be problematic which may causewound dehiscence and result in infection.

Within the Wrightington, Wigan andLeigh NHS Trust, an audit in 2011revealed an overall SSI rate in Caesareansection patients of 12%, higher than the9.6% UK rate uncovered by Wloch et al(2013). In one group of patients in theaudit, those with BMI>35, it was noticedthat 3-4 patients per month were readmittedwith wound dehiscence as a result ofsurgical site infection (Bullough,Wilkinson, Burns and Wan 2014).

The findings prompted the Trust toimplement an improvement programme tomitigate against the risk of SSI followingCaesarean section deliveries. In the firstinstance wound care practice was changedto help reduce the overall surgical siteinfection rate across all patientsundergoing Caesarean deliveries. A simpletransparent, film dressing (Opsite Post-OpVisible (Smith and Nephew, Hull) was introduced as the standard dressingto be used in Caesarean section patientsimmediately post-operatively. Dressings

Age (years) All patientsMean 30.2Median 30Std 5.3Min 17Max 42N 238BMI (Kg/m2)<40 159 (66.5%)>=40 80 (33.5%)Mean 39.4Median 38Std 5.4Min 35Max 70N 239

Table 1: Demographic data

C-Section Details All patients1st C-Section 123 (64.7%)2nd C-Section 60 (31.6%)3rd C-Section 4 (2.1%)4th C-Section 3 (1.6%)N 190 (100%)C-Section TypeElective 119 (51.1%)Emergency 114 (48.9%)N 233 (100%)

Table 2: Patient history

Fig. 2a shows the number of C-Section operations per month in high BMI patients.

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It is essential that we do all we can to help minimise

the risk of infection for patients undergoing

Caesarean section procedures.


of infection increases the more overweightthe woman is (Health protection Agency,2009).

Those patients who are overweight(BMI 25-30) are 1.6 times more likely to develop an infection, obese women (BMI 30-35) are 2.4 times more likelyand those with a BMI over 35, 3.7 timesmore likely. According to Wloch et al(2013), patients with a high BMI wereshown to have an SSI rate post Caesareansection of 19.2%, almost double the average.

Analysis of data from a single hospitalTrust in England confirmed that womenwith high BMI were at increased risk ofpost-operative wound complications andreadmission. The audit findings from2011 indicated an overall infection rate ofaround 12%. Having put steps in place toimprove the management of post-

patient group with BMI<35 (n = 1405),who were treated with Opsite Post-OpVisible, there were 51 confirmedinfections, giving a rate of 3.6%. Therewere no wound dehiscences and nopatients were readmitted as a result ofinfections in this group. In women withBMI>35 treated with PICO (n = 239),only one patient developed a woundinfection (0.4%). The patient whodeveloped an infection had gestationaldiabetes and was having her secondCaesarean section. The infection wassuperficial in nature and the patient was notreadmitted to hospital for treatment.

DiscussionObesity is strongly associated with the risk of developing an infection. Whethersuperficial, deep or organ/space, the risk

education on the application andmanagement of the PICO therapy.

Post-discharge surveillance wascompleted and patients were monitoredfor 30 days post-operatively. Infectionswere confirmed with both clinicalobservation and microbiologicalinvestigation. Wound assessment ofinfection would be carried out accordingto the criteria set out by Wilson, Treasure,Sturridge and Gruneberg (1986). TheASEPSIS scoring tool set out to provide aless subjective method of assessing woundinfection. Criteria included the level ofinfection, superficial, deep or organ space,the presence of erythema and or cellulitis. In addition, the level and type of exudate,whether serous haemoserous or purulentin nature is monitored and recorded.

Results of the evaluationDemographic dataOver a 30 month period between February2012 and July 2014, the Trust conducted1644 Caesarean deliveries. The average ageof the patients undergoing a Caesareansection was 30.2 years (median 30, range18-42 years). The average Body MassIndex of the patient undergoing aCaesarean was 39.4 Kg/m2 (median 37,range 35-70). Of these, 239 Caesareandeliveries were conducted on women witha BMI>35. Almost one third of thesepatients (32.6%, n=78) had a BMIgreater than or equal to 40. (See figure 4).In all cases, patients with a BMI>35 weretreated with the PICO NPWT systemwhile those with a BMI<35 were treatedwith the post-operative film dressing. (Table 1) shows the demographic data for the patient group including BMI.

Caesarean detailsInformation was available for the type(elective/emergency) of Caesarean in233/239 PICO treated cases; 119(51.1%) were elective and 114 (48.9%)were emergency (see table 2). Details of patient history were availablefrom 190 patients; in 123 (64.7%) casesthe Caesarean was the patient’s firstCaesarean, in 60 (31.6%) it was thepatient’s second Caesarean, in 4 (2.1%) it was the patient’s third Caesarean and in 3 (1.6%) it was the patient’s fourthCaesarean, (see table 2).

SSI outcomesIn all patients (n =1644) there were 52 recorded wound infections fromFebruary 2012 until July 2014 (~3.2%).This represents an overall reduction of73.3% from the previous rate of 12%identified in the Trust during an audit in 2011. All infections identified wererecorded as superficial infections and no patients had an infection or wounddehiscence requiring readmission. In the

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Fig. 3 Number of wound infections. (Total patients = 1644)

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0 2012 2013 2014 Overall

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30 (43%) 54 (49%) 30 (57%) 114 (49%)

40 (57%) 56 (51%) 23 (43%) 119 (51%)

Number ofpatients with no infection

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0Number of patients in PICO Group withinfection (1)

C section patients

Fig. 2b Number of C-section operations per year in high BMI patients, showing procedure type.

Number ofpatients withinfection

Number of patients inOpsite Post-Op VisibleGroup with infection (51)

One patient developed a superficial wound infection followinghaematoma formation. The patient had gestational diabetesand her BMI was 45. The patient was not readmitted with thiswound infection.


risk patients can potentially reduce woundcomplications, readmission rates and mayreduce the overall incidence of woundbreakdown in this vulnerable patientgroup. In addition, the positive impact onthe patient and families’ well-being duringa very important time in their lives cannotbe ignored.

More importantly, this project identifiedthe need for improved staff education, a better understanding of wound care issuesand encouraged all staff to take ownershipof this problem. The additional cost of thedressing is significantly off set by thereduction in re-admission rate suggestingthis protocol is extremely cost effective.

The authors point out that thisevaluation is not a randomised trial but a case series/evaluation intended to showa reduction in wound infection whenutilising a new therapy. The numbers arenot high enough to show significance.Despite this, however, there areencouraging indications that the therapymay have a beneficial role to play in theincision management of high risk patients.

Conflict of interestThis work was not funded by Smith andNephew; however, support was providedby the company in relation to training andeducation of staff in the application of thetherapy. Assistance was also provided inwriting up the results of the evaluation. ✚

However, while these are all shortcomingsof the current evaluation, it should also benoted that the data presented are derivedfrom routine data on patients managed ina real world setting. The patients treatedwere not subject to eligibility criteria asmight be the case in a clinical trial andtreatment reflected day-to-day practice in the hospital. In light of this, it could be argued that the findings should be more readily reproducible than a clinicaltrial.

ConclusionIt is essential that we do all we can to helpminimise the risk of infection for patientsundergoing Caesarean section procedures.One way to do this is to identify criteriawhich may deem a patient at higher riskof wound complications either due totheir body weight or their relative healthat the time of surgery. The next step is toget all staff to buy in to the process. In this case, tissue viability, infectioncontrol, obstetricians, midwives and wardmanagers were all involved in the changesbeing implemented. For the majority ofpatients negative pressure wound therapymay not be necessary; however, for thehigh risk patients it would appear that thisshould be considered as an alternative totraditional dressings.

This study demonstrates that usingPICO NPWT on closed incisions in high

operative wounds following Caesareansections, the Trust has witnessed a notableimprovement in patient outcomes. Thisanalysis reports on a case series of 239women with BMI>35 who underwentCaesarean section procedures. A baselineaudit conducted by the Trust suggestedthat they were experiencing 3-4 patientreadmissions as a result of woundcomplications prior to the introduction ofthe steps described herein. Furthermore,applying data derived from the nationalaudit, we would anticipate around almost20% (~45 of these women) might beexpected to experience a surgical siteinfection. In the case audit findingsreported here, we identified only oneinfection in the PICO group. The onepatient who developed the woundinfection in this evaluation also haddiabetes, which according to Wloch et al (2013) correlates with a higher thannormal wound infection rate of 15.6% in Caesarean section patients.

This not only has important patientbenefits but also economic implicationsfor the Trust. The recent study by Jenks et al reported an average cost per SSIfollowing Caesarean section procedures of approximately £3,700. Based on thepredicted number of 45 infections,discussed above, the Trust could haveexpected to incur a treatment cost of around£165,000 had they not implemented theprotocols described herein.

In addition to the clinical and economicbenefits the changes to practice describedhave also resulted in meaningful patientbenefits. Infections following Caesareansections can be painful and traumatic for women at a time when they want tofocus on caring for their newborn. The avoidance of these is therefore a highly desirable outcome. Other authorshave also noted how NPWT provides a ‘stenting’ effect at the surgical incision and anecdotal reports from women treatedwith PICO suggest that it provides womenwith a degree of security that their surgicalincision is being supported.

Limitations of the studyThe authors are keen to highlight thelimitations of the findings reported herein.The findings are derived from an audit ofroutinely collected data. Such an approachalso faces challenges of missing data aswas the case in the current analysis. It isalso important to note that we comparedour findings to historic controls alsoreported from routine data. As such, thiscannot be considered a comparative study.It is also true that other variables may havechanged over the course of the 2-3 yearsduring which new post-operative woundmanagement protocols were put in placeand that these too may have contributed to any improvements identified.

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Fig. 4 The number of patients in the high risk group per operation type.

Item Previous Protocol New ProtocolPICO £0 £11,476*Re-admissions (assuming 3 per month prior to study) £133,776 £0Total £133,776 £11,476Savings Annually £122,300If using Jenks et al (2014) estimated cost of SSI = £3,716 per patient episode. *average of 7.97 patients with high BMI per month

Table 3 Breakdown of expected costs for high risk patient group

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100%

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70%

60%

50%

40%

30%

20%

10%

0>35 - <40 >=40

Body Mass index (kg/m2)

Elective

Emergency

79 (51%) 35 (45%)

76 (49%) 43 (55%)


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AuthorsLindsey Bullough is a Tissue ViabilityNurse, at the Royal Albert EdwardInfirmary, Wigan. Co-authors: Mr Sean Burns MRCOG clinical director,Dept. Obstetrics and Gynaecology,Wrightington, Wigan and Leigh NHSFoundation Trust; John Timmons, clinical project manager, Smith andNephew Healthcare, (Literature search and editorial support); Paul Truman, vice president, Market Access, Smith andNephew Healthcare (Health Economics);Sarah Megginson, statistician, (data analysis and presentation).

References• Atkins, B. Z., Wooten, M. K., Kistler, J.,

Hurley, K., Hughes, G. C., & Wolfe, W. G.(2009). Does negative pressure woundtherapy have a role in preventing poststernotomy wound complications? Surgical Innovation, 16 (2), 140–6. Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/19460818

• Bullough L, Wilkinson D, Burns S and Wan L (2014) Changing protocols to reduce postoperative caesarean sectioninfection and dehiscence, Wounds UK, Vol 10, No 1, pp 72-76.

• Chariker, M., Jeter, K., & Tintle, T. (1989).Effective management of incisional andcutaneous fistulae with closed suction wound drainage. Contemp Surg, 34, 59–63.Retrieved from http://www.drchariker.com/documents/EffectiveWoundManagement.pdf

• European Wound Management (2007)Association (EWMA). Position Document:Topical negative pressure in woundmanagement. London: MEP Ltd.

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