Negative Pressure Wound Therapy on Surgical Site Infections in Women Undergoing Elective Caesarean Sections: A Pilot RCT

Wendy Chaboyer, Vinah Anderson, Joan Webster, Anne Sneddon, Lukman Thalib, Brigid M Gillespie, Wendy Chaboyer, Vinah Anderson, Joan Webster, Anne Sneddon, Lukman Thalib, Brigid M Gillespie

Abstract

Obese women undergoing caesarean section (CS) are at increased risk of surgical site infection (SSI). Negative Pressure Wound Therapy (NPWT) is growing in use as a prophylactic approach to prevent wound complications such as SSI, yet there is little evidence of its benefits. This pilot randomized controlled trial (RCT) assessed the effect of NPWT on SSI and other wound complications in obese women undergoing elective caesarean sections (CS) and also the feasibility of conducting a definitive trial. Ninety-two obese women undergoing elective CS were randomized in theatre via a central web based system using a parallel 1:1 process to two groups i.e., 46 women received the intervention (NPWT PICO™ dressing) and 46 women received standard care (Comfeel Plus(®) dressing). All women received the intended dressing following wound closure. The relative risk of SSI in the intervention group was 0.81 (95% CI 0.38-1.68); for the number of complications excluding SSI it was 0.98 (95% CI 0.34-2.79). A sample size of 784 (392 per group) would be required to find a statistically significant difference in SSI between the two groups with 90% power. These results demonstrate that a larger definitive trial is feasible and that careful planning and site selection is critical to the success of the overall study.

Keywords: NPWT; caesarean section; obesity; surgical site infection.

Figures

Figure 1
Figure 1
Participant Flow Diagram.
Figure 2
Figure 2
Power Curve.

References

    1. World Health Organization 10 Facts on Safe Surgery. [(accessed on 15 August 2014)]. Available online:
    1. Australia’s Hospitals 2008–2009—At a Glance. Australian Institute of Health and Welfare; Canberra, Australia: 2010.
    1. Mangram A.J., Horan T.C., Pearson M.L., Silver L.C., Jarvis W.R. Guideline for prevention of surgical site infection, 1999. Infect. Control Hosp. Epidemiol. 1999;20:247–280.
    1. Anderson D.J. Surgical site infections. Infect. Dis. Clin. 2011;25:135–153. doi: 10.1016/j.idc.2010.11.004.
    1. Graves N., Halton K., Curtis M., Doidge S., Lairson D., McLaws M., Whitby M. Costs of surgical site infections that appear after hospital discharge. Emerg. Infect. Dis. 2006;12:831–834. doi: 10.3201/eid1205.051321.
    1. Waisbren E., Rosen H., Bader A.M., Lipsitz S.R., Rogers S.O., Jr., Eriksson E. Percent body fat and prediction of surgical site infection. J. Am. Coll. Surg. 2010;210:381–389. doi: 10.1016/j.jamcollsurg.2010.01.004.
    1. National Health Survey 2007–2008, Cat 4364.0. Australian Bureau of Statistics; Canberra, Australia: 2008.
    1. Heslehurst N., Simpson H., Ells L.J., Rankin J., Wilkinson J., Lang R., Brown T.J., Summerbell C.D. The impact of maternal bmi status on pregnancy outcomes with immediate short-term obstetric resource implications: A meta-analysis. Obes. Rev. 2008;9:635–683. doi: 10.1111/j.1467-789X.2008.00511.x.
    1. Callaway L.K., Prins J.B., Chang A.M., McIntyre H.D. The prevalence and impact of overweight and obesity in an Australian obstetric population. Med. J. Aust. 2006;184:56–59.
    1. Ramachenderan J., Bradford J., McLean M. Maternal obesity and pregnancy complications: A review. Aust. N. Zeal. J. Obstetr. Gynaecol. 2008;48:228–235. doi: 10.1111/j.1479-828X.2008.00860.x.
    1. Ezechi O.C., Edet A., Akinlade H., Gab-Okafor C.V., Herbertson E. Incidence and risk factors for caesarean wound infection in lagos nigeria. BMC Res. Notes. 2009;2:186.
    1. De Lissovoy G., Fraeman K., Hutchins V., Murphy D., Song D., Vaughn B.B. Surgical site infection: Incidence and impact on hospital utilization and treatment costs. Am. J. Infect. Control. 2009;37:387–397.
    1. Fleischmann W., Lang E., Russ M. Treatment of infection by vacuum sealing. Unfallchirurg. 1997;100:301–304.
    1. Morykwas M.J., Argenta L.C., Shelton-Brown E.I., McGuirt W. Vacuum-assisted closure: A new method for wound control and treatment: Animal studies and basic foundation. Ann. Plast Surg. 1997;38:553–562. doi: 10.1097/00000637-199706000-00001.
    1. Vikatmaa P., Juutilainen V., Kuukasjarvi P., Malmivaara A. Negative pressure wound therapy: A systematic review on effectiveness and safety. Eur. J. Vasc. Endovasc. Surg. 2008;36:438–448. doi: 10.1016/j.ejvs.2008.06.010.
    1. Webster J., Scuffham P., Sherriff K.L., Stankiewicz M., Chaboyer W.P. Negative pressure wound therapy for skin grafts and surgical wounds healing by primary intention. Cochr. Database Syst. Rev. 2012 doi: 10.1002/14651858.CD009261.pub2.
    1. Tipton A.M., Cohen S.A., Chelmow D. Wound infection in the obese pregnant woman. Semin. Perinatol. 2011;35:345–349. doi: 10.1053/j.semperi.2011.05.020.
    1. Mark K.S., Alger L., Terplan M. Incisional negative pressure therapy to prevent wound complications following cesarean section in morbidly obese women: A pilot study. Surg. Innov. 2013;21:345–349. doi: 10.1177/1553350613503736.
    1. Karlakki S., Brem M., Giannini S., Khanduja V., Stannard J., Martin R. Negative pressure wound therapy for management of the surgical incision in orthopaedic surgery: A review of evidence and mechanisms for an emerging indication. Bone Joint Res. 2013;2:276–284. doi: 10.1302/2046-3758.212.2000190.
    1. Hertzog M.A. Considerations in determining sample size for pilot studies. Res. Nurs. Health. 2008;31:180–191. doi: 10.1002/nur.20247.
    1. IBM SPSS Statistics for Windows. IBM Corp.; Armonk, NY, USA: 2012. Version 21.0.
    1. MedCalc for Windows. MedCalc Software; Ostend, Belgium: 1999. Version 12.5.
    1. Hintze J. Pass 12. NCSS, LLC.; Kaysville, Utah, USA: 2013.
    1. Apelqvist J., Armstrong D.G., Lavery L.A., Boulton A.J.M. Resource utilization and economic costs of care based on a randomized trial of vacuum-assisted closure therapy in the treatment of diabetic foot wounds. Am. J. Surg. 2008;195:782–788. doi: 10.1016/j.amjsurg.2007.06.023.
    1. Caesarean Section. National Institute for Health and Clinical Excellence; London, UK: 2011.
    1. Tita A.T., Rouse D.J., Blackwell S., Saade G.R., Spong C.Y., Andrews W.W. Emerging concepts in antibiotic prophylaxis for cesarean delivery: A systematic review. Obstetr. Gynecol. 2009;113:675–682. doi: 10.1097/AOG.0b013e318197c3b6.
    1. Baaqeel H., Baaqeel R. Timing of administration of prophylactic antibiotics for caesarean section: A systematic review and meta-analysis. BJOG. 2013;120:661–669.
    1. National Institute for Health and Clinical Excellence . In: National Institute for Health and Clinical Excellence. Nice Clinical Guideline 74: Surgical Site Infection: Prevention and Treatment of Surgical Site Infection. National Collaborating Centre for Women’s and Children’s Health, editor. RCOG Press; London, UK: 2008. pp. 4–28.
    1. Tuuli M.G., Rampersad R.M., Carbone J.F., Stamilio D., Macones G.A., Odibo A.O. Staples compared with subcuticular suture for skin closure after cesarean delivery: A systematic review and meta-analysis. Obstetr. Gynecol. 2011;117:682–690. doi: 10.1097/AOG.0b013e31820ad61e.
    1. Aabakke A.J., Krebs L., Pipper C.B., Secher N.J. Subcuticular suture compared with staples for skin closure after cesarean delivery: A randomized controlled trial. Obstetr. Gynecol. 2013;122:878–884. doi: 10.1097/AOG.0b013e3182a5f0c3.
    1. Dumville J.C., Walter C.J., Sharp C.A., Page T. Dressings for the prevention of surgical site infection. Cochrane Database Syst. Rev. 2011 doi: 10.1002/14651858.CD003091.pub2.
    1. Sackett D.L. Clinician-trialist rounds: 16. Mind your explanatory and pragmatic attitudes!—Part 1: What? Clin. Trials. 2013;10:495–498.
    1. Thabane L., Ma J., Chu R., Cheng J., Ismaila A., Rios L., Robson R., Thabane M., Giangregorio L., Goldsmith C. A tutorial on pilot studies: The what, why and how. BMC Med. Res. Methodol. 2010 doi: 10.1186/1471-2288-10-1.
    1. Howell R.D., Hadley S., Strauss E., Pelham F.R. Blister formation with negative pressure dressings after total knee arthroplasty. Curr. Orthop. Pract. 2011;22:176–179. doi: 10.1097/BCO.0b013e31820b3e21.
    1. Marcus B. The Sage Dictionary of Social Research Methods. SAGE Publications, Ltd.; London, UK: 2006. Composite measurement; pp. 35–36.
    1. Landis R.S., Beal D.J., Tesluk P.E. A comparison of approaches to forming composite measures in structural equation models. Org. Res. Methods. 2000;3:186–207. doi: 10.1177/109442810032003.
    1. Freemantle N., Calvert M., Wood J., Eastaugh J., Griffin C. Composite outcomes in randomized trials: Greater precision but with greater uncertainty? JAMA. 2003;289:2554–2559. doi: 10.1001/jama.289.19.2554.

Source: PubMed

赞助者和合作者

医疗条件

药物干预

3
订阅