SS  Vol.6 No.12 , December 2015
Incisional Negative Pressure Wound Therapy in the Prevention of Surgical Site Infection after Vascular Surgery with Inguinal Incisions: Rationale and Design of a Randomized Controlled Trial (INVIPS-Trial)
Abstract: Background/Aims: Inguinal incisions are a common route of access in vascular surgery. Due to anatomical challenges and a diverse bacterial flora in this area, surgical site infections (SSI) represent a common, debilitating and sometimes life-threatening complication. The INVIPS-Trial evaluates the role of Negative Pressure Wound Therapy (NPWT) on closed inguinal incisions in elective vascular surgery to prevent SSI and other wound complications. Methods: This randomized controlled trial (RCT) registered at (Identifier: NCT01913132) compares the effects of a NPWT dressing (PICO, Smith & Nephew, UK) and the center’s standard wound dressing (Vitri Pad, ViTri Medical, Sweden) on postoperative wound complications, especially SSI. The study includes two distinct vascular procedures with different SSI risk profiles: endovascular aortic repair (EVAR) and open surgical approaches involving the common femoral artery (OPEN). Results: Four hundred ninety-five groin incisions in both treatment arms are anticipated to be included in the EVAR group and 147 inguinal incisions in both treatment arms in the OPEN group. Since a large percentage of inguinal vascular procedures in both groups but especially in the EVAR group are performed bilaterally, many patients can serve as their own control by randomly receiving NPWT on one and the standard dressing on the contralateral inguinal incision. Conclusions: This ongoing RCT attempts to elucidate the potential benefit of NPWT on closed inguinal incisions after different vascular procedures. Outcome and conclusions of this trial could have implications on postoperative wound care of patients in both vascular surgery and other surgical specialties.
Cite this paper: Hasselmann, J. , Kühme, T. , Björk, J. and Acosta, S. (2015) Incisional Negative Pressure Wound Therapy in the Prevention of Surgical Site Infection after Vascular Surgery with Inguinal Incisions: Rationale and Design of a Randomized Controlled Trial (INVIPS-Trial). Surgical Science, 6, 562-571. doi: 10.4236/ss.2015.612080.

[1]   Grice, E.A. and Segre, J.A. (2011) The Skin Microbiome. Nature Reviews Microbiology, 9, 244-253.

[2]   Giovannacci, L., Renggli, J.C., Eugster, T., Stierli, P., Hess, P. and Gurke, L. (2001) Reduction of Groin Lymphatic Complications by Application of Fibrin Glue: Preliminary Results of a Randomized Study. Annals of Vascular Surgery, 15, 182-185.

[3]   Turtiainen, J., Saimanen, E., Partio, T., et al. (2010) Surgical Wound Infections after Vascular Surgery: Prospective Multicenter Observational Study. Scandinavian Journal of Surgery, 99, 167-172.

[4]   Engin, C., Posacioglu, H., Ayik, F. and Apaydin, A.Z. (2005) Management of Vascular Infection in the Groin. Texas Heart Institute Journal, 32, 529-534.

[5]   Webster, J., Scuffham, P., Stankiewicz, M. and Chaboyer, W.P. (2014) Negative Pressure Wound Therapy for Skin Grafts and Surgical Wounds Healing by Primary Intention. Cochrane Database of Systematic Reviews, 10, Article ID: CD009261.

[6]   Kilpadi, D.V. and Cunningham, M.R. (2011) Evaluation of Closed Incision Management with Negative Pressure Wound Therapy (CIM): hematoma/seroma and involvement of the lymphatic system. Wound Repair and Regeneration, 19, 588-596.

[7]   Stannard, J.P., Robinson, J.T., Anderson, E.R., McGwin Jr., G., Volgas, D.A. and Alonso, J.E. (2006) Negative Pressure Wound Therapy to Treat Hematomas and Surgical Incisions Following High-Energy Trauma. The Journal of trauma, 60, 1301-1306.

[8]   Wilkes, R.P., Kilpad, D.V., Zhao, Y., Kazala, R. and McNulty, A. (2012) Closed Incision Management with Negative Pressure Wound Therapy (CIM): Biomechanics. Surgical Innovation, 19, 67-75.

[9]   Eisenhardt, S.U., Schmidt, Y., Thiele, J.R., et al. (2012) Negative Pressure Wound Therapy Reduces the Ischaemia/ Reperfusion-Associated Inflammatory Response in Free Muscle Flaps. Journal of Plastic Reconstructive and Aesthetic Surgery, 65, 640-649.

[10]   Malmsjo, M., Huddleston, E. and Martin, R. (2014) Biological Effects of a Disposable, Canisterless Negative Pressure Wound Therapy System. Eplasty, 14, e15.

[11]   Hasselmann, J., Kuhme, T. and Acosta, S. (2015) Antibiotic Prophylaxis with Trimethoprim/Sulfamethoxazole Instead of Cloxacillin Fails to Improve Inguinal Surgical Site Infection Rate after Vascular Surgery. Vascular and Endovascular Surgery, 49, 129-134.

[12]   Mangram, A.J., Horan, T.C., Pearson, M.L., Silver, L.C. and Jarvis, W.R. (1999) Guideline for Prevention of Surgical Site Infection, 1999. Centers for Disease Control and Prevention (CDC) Hospital Infection Control Practices Advisory Committee. American Journal of Infection Control, 27, 97-132; Quiz 3-4; Discussion 96.

[13]   Schoenborn, C.A. and Adams, P.E. (2010) Health Behaviors of Adults: United States, 2005-2007. Vital and Health Statistics, Series 10, 1-132.

[14]   Szilagyi, D.E., Smith, R.F., Elliott, J.P. and Vrandecic, M.P. (1972) Infection in Arterial Reconstruction with Synthetic Grafts. Annals of Surgery, 176, 321-333.

[15]   Faul, F., Erdfelder, E., Buchner, A. and Lang, A.G. (2009) Statistical Power Analyses Using G*Power 3.1: Tests for Correlation and Regression Analyses. Behavior Research Methods, 41, 1149-1160.

[16]   Fisher, R.A. (1925) Statistical Methods for Research Workers. Oliver & Boyd, Edinburgh.

[17]   Roberts, C. and Roberts, S.A. (2005) Design and Analysis of Clinical Trials with Clustering Effects Due to Treatment. Clinical Trials, 2, 152-162.

[18]   McCambridge, J., Witton, J. and Elbourne, D.R. (2014) Systematic Review of the Hawthorne Effect: New Concepts Are Needed to Study Research Participation Effects. Journal of Clinical Epidemiology, 67, 267-277.

[19]   Matatov, T., Reddy, K.N., Doucet, L.D., Zhao, C.X. and Zhang, W.W. (2013) Experience with a New Negative Pressure Incision Management System in Prevention of Groin Wound Infection in Vascular Surgery Patients. Journal of Vascular Surgery, 57, 791-795.