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International Journal of Surgery 12 (2014) S64eS68

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International Journal of Surgery

journal homepage: www.journal-surgery.net

Original research

Preventive NPWT over closed incisions in general surgery: Does agematter?

Gianluca Pellino, Guido Sciaudone, Giuseppe Candilio, G. Serena De Fatico,Isabella Landino, Angela Della Corte, Raffaella Guerniero, Raffaella Benevento,Antonio Santoriello, Ferdinando Campitiello, Francesco Selvaggi, Silvestro Canonico*

Department of Medical, Surgical, Neurologic, Metabolic and Ageing Sciences, Second University of Naples, Naples, Italy

a r t i c l e i n f o

Article history:Received 15 May 2014Accepted 15 June 2014Available online 23 August 2014

Keywords:Negative pressure wound therapyColorectal surgeryBreastSurgical site infectionSurgical site eventSSIComplication

Abbreviations: ASA, American Society of Anesthmass index; CDC, Centers for Disease Control andpressure wound therapy; SD, standard deviation; SSE* Corresponding author. Department of Medical, Su

and Ageing Sciences, Second University of Naples, PiaItaly.

E-mail addresses: gipe1984@gmail.com (G. Pellino(G. Sciaudone), g.candilio@alice.it (G. Candilio), seFatico), isabella.landino@fastwebnet.it (I. Landin(A. Della Corte), raffaella.guerniero@libero.it (R. Guegmail.com (R. Benevento), antonio.santoriello@ferdinando.campitiello@unina2.it (F. Campitiell(F. Selvaggi), silvestro.canonico@unina2.it (S. Canonic

http://dx.doi.org/10.1016/j.ijsu.2014.08.3781743-9191/© 2014 Published by Elsevier Ltd on behal

a b s t r a c t

Surgical site events (SSE), including surgical wound complications and surgical site infections, are amajor concern in patients undergoing general surgery operations. These increase the costs of care, andcan lead to prolonged hospital stay and need for further treatments, ultimately resulting in poor qualityof life. Negative pressure wound therapy (NPWT) has been recently reported as a preventive strategy toavoid SSE, but little is known on the topic, and particularly in geriatric population.

Our primary aim was to assess the efficacy of NPWT by means of a pocket device (PICO, Smith &Nephew, London, UK) in preventing SSE compared with conventional dressings in patients undergoingsurgery with primary wound closure for breast and for colorectal diseases in our Unit. Our secondaryaims were to assess the efficacy and safety of PICO in elderly patients, and to seek for differences betweenbreast and abdominal results.

All consecutive patients undergoing breast and colorectal surgery in our Unit between September 2012and May 2014 were prospectively enrolled in this open label controlled study. Breast patients receivingNPWT were assigned to group B1, those receiving conventional dressings were assigned to group B2.Colorectal patients were assigned to group C1 (NPWT) and C2 (conventional dressings) in similar fashion.Each group included 25 patients, and at least 10 (40%) patients aged over 65 years to allow sub-analyses.

NPWT significantly reduced SSE in both breast and colorectal patients compared with controls. Nosignificant differences were observed according to age. Similar benefits were observed in breast andcolorectal patients.

Our results suggest that PICO is an effective tool to prevent SSE in patients undergoing general surgery,irrespective of age. Its use is recommended in frail, elderly patients at risk of SSE.

© 2014 Published by Elsevier Ltd on behalf of Surgical Associates Ltd.

esiologists score; BMI, bodyPrevention; NPWT, negative, surgical site events.rgical, Neurologic, Metaboliczza Miraglia 2, 80138 Naples,

), guido.sciaudone@unina2.itredefa@gmail.com (G.S. Deo), angeladellacorte@live.itrniero), raffaella.benevento@unina2.it (A. Santoriello),o), fselvaggi@hotmail.como).

f of Surgical Associates Ltd.

1. Introduction

Surgical site events (SSE) are responsible for increasedmorbidity in patients undergoing general surgery, and can causeprolonged length of stay in the hospital [1,2]. SSE have a detri-mental effect on the costs of hospital care, with more than 1.5billion dollars in excess cost in the United States [3]. Althoughseveral risk factors for SSE have been described [2e4], the rates ofSSE remain disturbingly high, and the preventing strategies need tobe implemented [4,5] as well as surgical teams adherence to these[5].

Negative Pressure Wound Therapy (NPWT) reduces the inci-dence of SSE in patients at risk, as we recently reported in a pro-spective study on Crohn's disease patients receiving NPWT with apocket, disposable device, the PICO (Smith & Nephew, London, UK)

G. Pellino et al. / International Journal of Surgery 12 (2014) S64eS68 S65

[2]. The use of PICO for preventing SSE in patients undergoingsurgery with primary wound closure has been poorly investigatedas well as its effects in elderly patients.

The primary aim of our study was to evaluate the efficacy ofPICO compared with conventional dressings in preventing SSE inpatients undergoing surgerywith primarywound closure for breastand colorectal diseases. The secondary aims were: to assess theefficacy and safety of PICO in elderly patients; to seek for outcomedifferences between breast and abdominal surgery.

2. Material and methods

All patients scheduled for breast or colorectal surgery in our Unitbetween September 2012 and May 2014 were considered for in-clusion. This is an open-label, prospective, controlled trial.

Written informed consent was obtained by each patient. Pa-tients undergoing breast surgery were assigned to either group B1if they received NPWT with PICO or group B2 if they receivedconventional dressings. Patients undergoing colorectal surgerywere similarly assigned to either group C1 (PICO) or group C2(conventional dressings). Each group comprised 25 patients, ofwhom 10 (40%) aged over 65 years. Each group included amaximum of 12 patients with malignancies.

Patient selection, surgical procedures, wound closure as well asapplication of NPWT with PICO and protocol of medication withconventional dressings in controls were performed as previouslyreported [2,6e19].

Briefly, at the end of each procedure the wound edges wereapproximated by means of running sub-cuticular suture with non-absorbable stitches (3/0, polypropylene/polyethylene). In group B1and C1, PICO was applied (automatically set at �80 mmHg). Gauzeswere changed when too wet or after 3 days for the follow-up; thedevice was always removed on the postoperative day 7. In group B2and C2 basic wound contact absorbent dressings were used,removed sterilely for control after 48 h. On post-operative day 3,gauzes were removed sterilely and wounds left exposed if nocomplications occurred.

All patients received perioperative antibiotic prophylaxis[2,6,10].

2.1. Data of interest and follow-up protocol

Demographics, American Society of Anesthesiologists (ASA)score, body mass index (BMI), comorbidities, concomitant medicaltreatment, length of incision, length of surgical procedure, in-hospital stay, and perioperative complications were collected.

SSE were evaluated on postoperative-day 3, 7 and 30. Nonin-fectious and septic wound complications were classified accordingto Centers for Disease Control and Prevention (CDC) criteria [2,6,20]and Global ASEPSIS score [2,6,21], respectively. Sub-group analyseswere performed according to age.

After discharge, standard follow-up intervals for this study wereat 7, 15 and 30 days, subsequently every two weeks for 3 months.

Overall results of breast patients were compared with those ofcolorectal patients.

2.2. Statistical analysis

Results are expressed as mean ± SD, unless otherwise indicated.Categorical datawere compared using 2-tailed Fisher's exact test orChi-squared test; continuous variables were compared usingManneWhitney test. P < 0.05 was considered statisticallysignificant.

3. Results

Baseline and surgical characteristics of all included patients arereported in Table 1. No differences were observed in mean age ofpatients in both groups. Breast surgery patients were all females,while 22 male and 28 female were included in colorectal groups(p < 0.0001). BMI, comorbidities, and ASA did not significantlydiffer between groups, and between breast and colorectal surgerypatients. Mean operative time and mean wound length weresignificantly higher in patients undergoing colorectal surgery(p < 0.0001 and p ¼ 0.003, respectively). No differences wereobserved in baseline and surgical data between B1 and B2, andbetween C1 and C2 patients (Table 1).

No perioperative deaths occurred, and major postoperativecomplications were similar between groups.

Outcomes of surgery and wound assessment are depicted inTable 2. Length of in-hospital stay did not differ between B1 and B2,but was almost reduced by half in colorectal patients with PICOcompared with controls (C1 vs C2 7.1 ± 2.1vs 12 ± 3.5 days,p ¼ 0.001). Colorectal patients had longer length of stay comparedwith breast patients (p < 0.0001). Rates of seroma were similarbetween B1 and B2 patients, while in colorectal patients thesewerehigher in controls (C1 vs C2 8% vs 40%, p ¼ 0.02).

SSE according to CDC criteria were significantly lower in allpatients receiving PICO (B1 vs B2 p ¼ 0.04; C1 vs C2 p ¼ 0.008).Similarly, ASEPSIS scores were lower with PICO (B1 vs B2 p ¼ 0.03;C1 vs C2 p ¼ 0.01).

Sub-analyses of patients aged over 65 years showed that therates of seroma were similar between PICO and controls, and be-tween breast and colorectal patients. Conversely, the rates of in-fectious SSE were much lower with PICO, compared with youngerpatients, irrespective of the type of surgery (B1 vs B2, 0% vs 50%,p ¼ 0.003; C1 vs C2, 10% vs 60%, p ¼ 0.003; breast vs colorectalp > 0.99).

4. Discussion

Our data support the use of NPWT with PICO as an effectivepreventive measure against SSE in patients undergoing generalsurgery. No differences should be expected between breast andcolorectal surgery, with similar benefits. When considering elderlypatients, the results are even more apparent.

SSE significantly affect quality of life of patients undergoinggeneral surgery, and increase the costs of hospital stay [1e6].Strategies have been proposed aiming to reduce the rate of infec-tious SSE, but adherence to these guidelines may be suboptimal [5].This can be attributed to little understanding of SSE by surgeons,despite infectious SSE are reported to account for almost 10% of in-hospital infections [1,2].

It has been reported that several factors may predict higher risksof developing SSE, potentially allowing a better patient selection,aimed to obtain the ideal risk-benefit balance and to limit the costsdue to inappropriate NPWT indication. Aiming to identify pre-dictors of SSE, Hedrick et al. [22] retrospectively evaluated themedical records of 18,403 patients undergoing colorectal surgery,showing a rate of infectious SSE as high as 7.86%. By means ofmultivariable logistic regression analysis, they identified severalpredictors of infectious SSE (age, alcohol abuse, ASA classification,stoma closure, open approach, BMI, and haematocrit), and pro-posed predictive normograms according to these findings [22]. Wewould add another category of patients at risk, inflammatory boweldisease patients. These patients may undergo surgery at any age[14,18,19], they may need to undergo repeated procedures[2,6,18,19,23e33], and may be operated on while receiving immu-nodepressant medications [14,19,34e39], further increasing the

Table 1Characteristics and surgical data of patients undergoing breast (B) or colorectal (C) surgery. Data are mean ± SD and n (%).

Variable Group B1(n ¼ 25)

Group B2(n ¼ 25)

P Group C1(n ¼ 25)

Group C2(n ¼ 25)

P B Vs C Pa

Age, years (patients < 65) 36.4 ± 11.4 38 ± 14.8 0.8 39 ± 10.1 38 ± 15.4 0.8 0.7Age, years (overall) 49.7 ± 18.6 50.6 ± 17.6 0.8 52 ± 10.5 51.3 ± 19.2 0.9 0.8Male 0 (0) 0 (0) >0.99 13 (52) 9 (36) 0.4 <0.0001BMI, kg/m2 22.2 ± 2.7 22 ± 2.1 0.9 22.7 ± 6 21.2 ± 4.3 0.6 >0.99Diabetes 5 (20) 4 (16) >0.99 4 (16) 5 (20) >0.99 >0.99ASA score � 2 4 (16) 3 (12) >0.99 3 (12) 3 (12) >0.99 >0.99Duration of surgery, minutes 72.3 ± 7.9 75 ± 9.2 0.3 169 ± 81 190 ± 75 0.7 <0.0001Wound length 9.3 ± 5.5 8 ± 3.4 0.08 11.6 ± 7.2 12.4 ± 7.7 >0.99 0.003

SD: standard deviation; ASA: American Society of Anesthesiologists; BMI: body mass index.B1, C1: NPWT with PICO; B2, C2: conventional dressings.Statistically significant P values are in bold.

a Overall B vs C comparison.

Table 2General and wound-related complications patients undergoing breast (B) or colorectal (C) surgery. Data are mean ± SD and n (%).

Surgical complications Group B1(n ¼ 25)

Group B2(n ¼ 25)

P Group C1(n ¼ 25)

Group C2(n ¼ 25) P B Vs C Pa

Death 0 (0) 0 (0) >0.99 0 (0) 0 (0) >0.99 >0.99Major complications 3 (12) 2 (8) >0.99 5 (20) 6 (24) >0.99 0.2Hospital stay, days 2 ± 1.2 2 ± 0.5 0.8 7.1 ± 2.1 12 ± 3.5 0.001 <0.0001Wound outcomeSeroma 1 (4) 5 (20) 0.1 2 (8) 10 (40) 0.02 0.2Infectious SSE according to CDC criteria(2,6,20) 2 (8) 9 (36) 0.04 2 (8) 11 (44) 0.008 0.8Global ASEPSIS score(2,6,21) 12 ± 3.2 18.2 ± 5.1 0.03 14.6 ± 4.7 25.3 ± 3.3 0.01 0.07

Patients > 65-year-of-age Group B1(n ¼ 10)

Group B2(n ¼ 10)

P Group A(n ¼ 10)

Group B(n ¼ 10)

P

Seroma 0 (0) 4 (40) 0.09 1 (10) 4 (40) 0.3 >0.99Infectious SSE according to CDC criteria(2,6,20) 0 (0) 5 (50) 0.003 1 (10) 6 (60) 0.003 >0.99

SD: standard deviation; ASA: American Society of Anesthesiologists; BMI: body mass index; CDC: Centers for Disease Control and Prevention; SSE: Surgical Site Events.B1, C1: NPWT with PICO; B2, C2: conventional dressings.Statistically significant P values are in bold.

a Overall B vs C comparison.

G. Pellino et al. / International Journal of Surgery 12 (2014) S64eS68S66

risk of SSE. Also, an increased risk of SSE due to an altered immuneresponse and genetic predisposition cannot be ruled out, consid-ering the autoimmune aetiopathogenesis of the diseases as well asthe importance of genetic and epigenetic predisposing factors[40e42], which may also increase the rate of cancer risk and needfor surgery for malignancies [43e53].

Concerning age at surgery, advanced age significantly increasedthe risk of SSE when compared with younger patients [22]. Thismay be due to higher rates of comorbidities, drug intake, andchronic disease, and should be posed into perspectivewhen dealingwith elderly patients candidate to general surgery.

Cima et al. [54] recently published the impact on the rates of SSEof a specific preventing algorithm in a single Center, suggestingthat, by adopting scheduled perioperativemeasures, theywere ableto reduce overall infectious SSE from 9.8% to 4.0% within one year.However, in the proposed algorithm, preventive NPWT is nevermentioned.

We recently suggested the effectiveness of PICO, a pocket,disposable NPWT device in reducing SSE of patients at risk [2,6].The cost of PICO is moderate, and its price may further be justifiedby the excess costs due to potential wound-related complications.Also, it avoids the cumbersomeness of conventional NPWT devices,and is user-friendly [2,6]. PICO favors healing through stimulationof angiogenesis and granulation tissue formation [55], in a “sealed”wound.

We showed that PICO can be safely delivered to patients un-dergoing general surgery, and prevents SSE over closed incisions.Moreover, elderly patients, who are known to be at higher risk ofSSE, would benefit from its use. We would recommend preventiveNPWT with PICO in frail elderly patients and in those with at least

another risk factor for SSE [22] undergoing general surgery, irre-spective of the type of surgery.

Ethical approval

Ethical approval was requested and obtained from the “SecondUniversity of Naples” ethical committee.

Funding

All Authors have no source of funding.

Author contribution

Gianluca Pellino: Participated substantially in conception,design, and execution of the study and in the analysis and inter-pretation of data; also participated substantially in the drafting andediting of the manuscript.

Guido Sciaudone: Participated substantially in conception,design, and execution of the study and in the analysis and inter-pretation of data.

Giuseppe Candilio: Participated substantially in conception,design, and execution of the study and in the analysis and inter-pretation of data.

G Serena De Fatico: Participated substantially in conception,design, and execution of the study and in the analysis and inter-pretation of data.

Isabella Landino: Participated substantially in conception,design, and execution of the study and in the analysis and inter-pretation of data.

G. Pellino et al. / International Journal of Surgery 12 (2014) S64eS68 S67

Angela Della Corte: Participated substantially in conception,design, and execution of the study and in the analysis and inter-pretation of data.

Raffaella Guerniero: Participated substantially in conception,design, and execution of the study and in the analysis and inter-pretation of data.

Raffaella Benevento: Participated substantially in conception,design, and execution of the study and in the analysis and inter-pretation of data.

Antonio Santoriello: Participated substantially in conception,design, and execution of the study and in the analysis and inter-pretation of data.

Ferdinando Campitiello: Participated substantially in concep-tion, design, and execution of the study and in the analysis andinterpretation of data.

Francesco Selvaggi: Participated substantially in conception,design, and execution of the study and in the analysis and inter-pretation of data; also participated substantially in the drafting andediting of the manuscript.

Silvestro Canonico: Participated substantially in conception,design, and execution of the study and in the analysis and inter-pretation of data; also participated substantially in the drafting andediting of the manuscript.

Conflict of interest

The Authors have no conflict of interest or any financial support.

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