Skin Antisepsis before Surgical Fixation of Extremity Fractures.

Sheila Sprague; Gerard Slobogean; Jeffrey L. Wells; Nathan N. O'Hara; Lehana Thabane; C. Daniel Mullins; Anthony D. Harris; Amber Wood; Darius Viskontas; Kelly L. Apostle; Robert V. O'Toole; Manjari Joshi; Herman Johal; Jamal Al-Asiri; Robert A. Hymes; Greg E. Gaski; Holly T. Pilson; Eben A. Carroll; Sharon Babcock; Jason J. Halvorson; Nicholas M. Romeo; Christopher A. Matson; Thomas F. Higgins; Lucas S. Marchand; Patrick F. Bergin; John Morellato; Robert E. Van Demark; G. David Potter; I. Leah Gitajn; Gerard Chang; Kevin D. Phelps; Laurence B. Kempton; Madhav Karunakar; Todd Jaeblon; Haley K. Demyanovich; Christopher M. Domes; Gabrielle R. Kuhn; Rachel M. Reilly; Mark J. Gage; Michael J. Weaver; Arvind G. Von Keudell; Marilyn Heng; Michael F. McTague; Ahmad Alnasser; Samir Mehta; Derek J. Donegan; Roman M. Natoli; Jan Szatkowski; Alesha N. Scott; Steven F. Shannon; Kyle J. Jeray; Stephanie L. Tanner; Meir T. Marmor; Amir Matityahu; Justin T. Fowler; Sarah N. Pierrie; Michael J. Beltran; Cameron G. Thomson; Carol A. Lin; Charles N. Moon; John A. Scolaro; Arya Amirhekmat; Jordan Leonard; David Pogorzelski; Sofia Bzovsky; Diane Heels-Ansdell; Olivia P. Szasz; Jodi L. Gallant; Gregory J. Della Rocca; Robert D. Zura; Joan N. Hebden; Joseph T. Patterson; Christopher Lee; Lyndsay M. O'Hara; Debra Marvel; Jana E. Palmer; Jeff Friedrich; Jean Claude G. D'Alleyrand; Jessica C. Rivera; Franca Mossuto; Gregory M. Schrank; Gordon Guyatt; P. J. Devereaux; Mohit Bhandari

doi:10.1056/NEJMoa2307679

Skin Antisepsis before Surgical Fixation of Extremity Fractures.

Sheila Sprague, Gerard Slobogean, Jeffrey L. Wells, Nathan N. O'Hara, Lehana Thabane, C. Daniel Mullins, Anthony D. Harris, Amber Wood, Darius Viskontas, Kelly L. Apostle, Robert V. O'Toole, Manjari Joshi, Herman Johal, Jamal Al-Asiri, Robert A. Hymes, Greg E. Gaski, Holly T. Pilson, Eben A. Carroll, Sharon Babcock, Jason J. HalvorsonNicholas M. Romeo, Christopher A. Matson, Thomas F. Higgins, Lucas S. Marchand, Patrick F. Bergin, John Morellato, Robert E. Van Demark, G. David Potter, I. Leah Gitajn, Gerard Chang, Kevin D. Phelps, Laurence B. Kempton, Madhav Karunakar, Todd Jaeblon, Haley K. Demyanovich, Christopher M. Domes, Gabrielle R. Kuhn, Rachel M. Reilly, Mark J. Gage, Michael J. Weaver, Arvind G. Von Keudell, Marilyn Heng, Michael F. McTague, Ahmad Alnasser, Samir Mehta, Derek J. Donegan, Roman M. Natoli, Jan Szatkowski, Alesha N. Scott, Steven F. Shannon, Kyle J. Jeray, Stephanie L. Tanner, Meir T. Marmor, Amir Matityahu, Justin T. Fowler, Sarah N. Pierrie, Michael J. Beltran, Cameron G. Thomson, Carol A. Lin, Charles N. Moon, John A. Scolaro, Arya Amirhekmat, Jordan Leonard, David Pogorzelski, Sofia Bzovsky, Diane Heels-Ansdell, Olivia P. Szasz, Jodi L. Gallant, Gregory J. Della Rocca, Robert D. Zura, Joan N. Hebden, Joseph T. Patterson, Christopher Lee, Lyndsay M. O'Hara, Debra Marvel, Jana E. Palmer, Jeff Friedrich, Jean Claude G. D'Alleyrand, Jessica C. Rivera, Franca Mossuto, Gregory M. Schrank, Gordon Guyatt, P. J. Devereaux, Mohit Bhandari

Research output: Contribution to journal › Article › peer-review

8 Scopus citations

Abstract

Background Studies evaluating surgical-site infection have had conflicting results with respect to the use of alcohol solutions containing iodine povacrylex or chlorhexidine gluconate as skin antisepsis before surgery to repair a fractured limb (i.e., an extremity fracture). Methods In a cluster-randomized, crossover trial at 25 hospitals in the United States and Canada, we randomly assigned hospitals to use a solution of 0.7% iodine povacrylex in 74% isopropyl alcohol (iodine group) or 2% chlorhexidine gluconate in 70% isopropyl alcohol (chlorhexidine group) as preoperative antisepsis for surgical procedures to repair extremity fractures. Every 2 months, the hospitals alternated interventions. Separate populations of patients with either open or closed fractures were enrolled and included in the analysis. The primary outcome was surgical-site infection, which included superficial incisional infection within 30 days or deep incisional or organ-space infection within 90 days. The secondary outcome was unplanned reoperation for fracture-healing complications. Results A total of 6785 patients with a closed fracture and 1700 patients with an open fracture were included in the trial. In the closed-fracture population, surgical-site infection occurred in 77 patients (2.4%) in the iodine group and in 108 patients (3.3%) in the chlorhexidine group (odds ratio, 0.74; 95% confidence interval [CI], 0.55 to 1.00; P=0.049). In the open-fracture population, surgical-site infection occurred in 54 patients (6.5%) in the iodine group and in 60 patients (7.3%) in the chlorhexidine group (odd ratio, 0.86; 95% CI, 0.58 to 1.27; P=0.45). The frequencies of unplanned reoperation, 1-year outcomes, and serious adverse events were similar in the two groups. Conclusions Among patients with closed extremity fractures, skin antisepsis with iodine povacrylex in alcohol resulted in fewer surgical-site infections than antisepsis with chlorhexidine gluconate in alcohol. In patients with open fractures, the results were similar in the two groups. (Funded by the Patient-Centered Outcomes Research Institute and the Canadian Institutes of Health Research; PREPARE ClinicalTrials.gov number, NCT03523962.)

Original language	English
Pages (from-to)	409-420
Number of pages	12
Journal	New England Journal of Medicine
Volume	390
Issue number	5
DOIs	https://doi.org/10.1056/NEJMoa2307679
State	Published - 1 Feb 2024
Externally published	Yes

Keywords

Bacterial Infections
Infectious Disease
Infectious Disease General
Orthopedics
Orthopedics General
Surgery
Surgery General

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10.1056/NEJMoa2307679

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Sprague, S., Slobogean, G., Wells, J. L., O'Hara, N. N., Thabane, L., Mullins, C. D., Harris, A. D., Wood, A., Viskontas, D., Apostle, K. L., O'Toole, R. V., Joshi, M., Johal, H., Al-Asiri, J., Hymes, R. A., Gaski, G. E., Pilson, H. T., Carroll, E. A., Babcock, S., ... Bhandari, M. (2024). Skin Antisepsis before Surgical Fixation of Extremity Fractures. New England Journal of Medicine, 390(5), 409-420. https://doi.org/10.1056/NEJMoa2307679

@article{f44bfa532adc4373b5fcb51cfa49204f,

title = "Skin Antisepsis before Surgical Fixation of Extremity Fractures.",

abstract = "Background Studies evaluating surgical-site infection have had conflicting results with respect to the use of alcohol solutions containing iodine povacrylex or chlorhexidine gluconate as skin antisepsis before surgery to repair a fractured limb (i.e., an extremity fracture). Methods In a cluster-randomized, crossover trial at 25 hospitals in the United States and Canada, we randomly assigned hospitals to use a solution of 0.7% iodine povacrylex in 74% isopropyl alcohol (iodine group) or 2% chlorhexidine gluconate in 70% isopropyl alcohol (chlorhexidine group) as preoperative antisepsis for surgical procedures to repair extremity fractures. Every 2 months, the hospitals alternated interventions. Separate populations of patients with either open or closed fractures were enrolled and included in the analysis. The primary outcome was surgical-site infection, which included superficial incisional infection within 30 days or deep incisional or organ-space infection within 90 days. The secondary outcome was unplanned reoperation for fracture-healing complications. Results A total of 6785 patients with a closed fracture and 1700 patients with an open fracture were included in the trial. In the closed-fracture population, surgical-site infection occurred in 77 patients (2.4%) in the iodine group and in 108 patients (3.3%) in the chlorhexidine group (odds ratio, 0.74; 95% confidence interval [CI], 0.55 to 1.00; P=0.049). In the open-fracture population, surgical-site infection occurred in 54 patients (6.5%) in the iodine group and in 60 patients (7.3%) in the chlorhexidine group (odd ratio, 0.86; 95% CI, 0.58 to 1.27; P=0.45). The frequencies of unplanned reoperation, 1-year outcomes, and serious adverse events were similar in the two groups. Conclusions Among patients with closed extremity fractures, skin antisepsis with iodine povacrylex in alcohol resulted in fewer surgical-site infections than antisepsis with chlorhexidine gluconate in alcohol. In patients with open fractures, the results were similar in the two groups. (Funded by the Patient-Centered Outcomes Research Institute and the Canadian Institutes of Health Research; PREPARE ClinicalTrials.gov number, NCT03523962.)",

keywords = "Bacterial Infections, Infectious Disease, Infectious Disease General, Orthopedics, Orthopedics General, Surgery, Surgery General",

author = "Sheila Sprague and Gerard Slobogean and Wells, {Jeffrey L.} and O'Hara, {Nathan N.} and Lehana Thabane and Mullins, {C. Daniel} and Harris, {Anthony D.} and Amber Wood and Darius Viskontas and Apostle, {Kelly L.} and O'Toole, {Robert V.} and Manjari Joshi and Herman Johal and Jamal Al-Asiri and Hymes, {Robert A.} and Gaski, {Greg E.} and Pilson, {Holly T.} and Carroll, {Eben A.} and Sharon Babcock and Halvorson, {Jason J.} and Romeo, {Nicholas M.} and Matson, {Christopher A.} and Higgins, {Thomas F.} and Marchand, {Lucas S.} and Bergin, {Patrick F.} and John Morellato and {Van Demark}, {Robert E.} and {David Potter}, G. and Gitajn, {I. Leah} and Gerard Chang and Phelps, {Kevin D.} and Kempton, {Laurence B.} and Madhav Karunakar and Todd Jaeblon and Demyanovich, {Haley K.} and Domes, {Christopher M.} and Kuhn, {Gabrielle R.} and Reilly, {Rachel M.} and Gage, {Mark J.} and Weaver, {Michael J.} and {Von Keudell}, {Arvind G.} and Marilyn Heng and McTague, {Michael F.} and Ahmad Alnasser and Samir Mehta and Donegan, {Derek J.} and Natoli, {Roman M.} and Jan Szatkowski and Scott, {Alesha N.} and Shannon, {Steven F.} and Jeray, {Kyle J.} and Tanner, {Stephanie L.} and Marmor, {Meir T.} and Amir Matityahu and Fowler, {Justin T.} and Pierrie, {Sarah N.} and Beltran, {Michael J.} and Thomson, {Cameron G.} and Lin, {Carol A.} and Moon, {Charles N.} and Scolaro, {John A.} and Arya Amirhekmat and Jordan Leonard and David Pogorzelski and Sofia Bzovsky and Diane Heels-Ansdell and Szasz, {Olivia P.} and Gallant, {Jodi L.} and {Della Rocca}, {Gregory J.} and Zura, {Robert D.} and Hebden, {Joan N.} and Patterson, {Joseph T.} and Christopher Lee and O'Hara, {Lyndsay M.} and Debra Marvel and Palmer, {Jana E.} and Jeff Friedrich and D'Alleyrand, {Jean Claude G.} and Rivera, {Jessica C.} and Franca Mossuto and Schrank, {Gregory M.} and Gordon Guyatt and Devereaux, {P. J.} and Mohit Bhandari",

note = "Publisher Copyright: {\textcopyright} 2024 Massachusetts Medical Society.",

year = "2024",

month = feb,

day = "1",

doi = "10.1056/NEJMoa2307679",

language = "English",

volume = "390",

pages = "409--420",

journal = "New England Journal of Medicine",

issn = "0028-4793",

number = "5",

}

Sprague, S, Slobogean, G, Wells, JL, O'Hara, NN, Thabane, L, Mullins, CD, Harris, AD, Wood, A, Viskontas, D, Apostle, KL, O'Toole, RV, Joshi, M, Johal, H, Al-Asiri, J, Hymes, RA, Gaski, GE, Pilson, HT, Carroll, EA, Babcock, S, Halvorson, JJ, Romeo, NM, Matson, CA, Higgins, TF, Marchand, LS, Bergin, PF, Morellato, J, Van Demark, RE, David Potter, G, Gitajn, IL, Chang, G, Phelps, KD, Kempton, LB, Karunakar, M, Jaeblon, T, Demyanovich, HK, Domes, CM, Kuhn, GR, Reilly, RM, Gage, MJ, Weaver, MJ, Von Keudell, AG, Heng, M, McTague, MF, Alnasser, A, Mehta, S, Donegan, DJ, Natoli, RM, Szatkowski, J, Scott, AN, Shannon, SF, Jeray, KJ, Tanner, SL, Marmor, MT, Matityahu, A, Fowler, JT, Pierrie, SN, Beltran, MJ, Thomson, CG, Lin, CA, Moon, CN, Scolaro, JA, Amirhekmat, A, Leonard, J, Pogorzelski, D, Bzovsky, S, Heels-Ansdell, D, Szasz, OP, Gallant, JL, Della Rocca, GJ, Zura, RD, Hebden, JN, Patterson, JT, Lee, C, O'Hara, LM, Marvel, D, Palmer, JE, Friedrich, J, D'Alleyrand, JCG, Rivera, JC, Mossuto, F, Schrank, GM, Guyatt, G, Devereaux, PJ & Bhandari, M 2024, 'Skin Antisepsis before Surgical Fixation of Extremity Fractures.', New England Journal of Medicine, vol. 390, no. 5, pp. 409-420. https://doi.org/10.1056/NEJMoa2307679

TY - JOUR

T1 - Skin Antisepsis before Surgical Fixation of Extremity Fractures.

AU - Sprague, Sheila

AU - Slobogean, Gerard

AU - Wells, Jeffrey L.

AU - O'Hara, Nathan N.

AU - Thabane, Lehana

AU - Mullins, C. Daniel

AU - Harris, Anthony D.

AU - Wood, Amber

AU - Viskontas, Darius

AU - Apostle, Kelly L.

AU - O'Toole, Robert V.

AU - Joshi, Manjari

AU - Johal, Herman

AU - Al-Asiri, Jamal

AU - Hymes, Robert A.

AU - Gaski, Greg E.

AU - Pilson, Holly T.

AU - Carroll, Eben A.

AU - Babcock, Sharon

AU - Halvorson, Jason J.

AU - Romeo, Nicholas M.

AU - Matson, Christopher A.

AU - Higgins, Thomas F.

AU - Marchand, Lucas S.

AU - Bergin, Patrick F.

AU - Morellato, John

AU - Van Demark, Robert E.

AU - David Potter, G.

AU - Gitajn, I. Leah

AU - Chang, Gerard

AU - Phelps, Kevin D.

AU - Kempton, Laurence B.

AU - Karunakar, Madhav

AU - Jaeblon, Todd

AU - Demyanovich, Haley K.

AU - Domes, Christopher M.

AU - Kuhn, Gabrielle R.

AU - Reilly, Rachel M.

AU - Gage, Mark J.

AU - Weaver, Michael J.

AU - Von Keudell, Arvind G.

AU - Heng, Marilyn

AU - McTague, Michael F.

AU - Alnasser, Ahmad

AU - Mehta, Samir

AU - Donegan, Derek J.

AU - Natoli, Roman M.

AU - Szatkowski, Jan

AU - Scott, Alesha N.

AU - Shannon, Steven F.

AU - Jeray, Kyle J.

AU - Tanner, Stephanie L.

AU - Marmor, Meir T.

AU - Matityahu, Amir

AU - Fowler, Justin T.

AU - Pierrie, Sarah N.

AU - Beltran, Michael J.

AU - Thomson, Cameron G.

AU - Lin, Carol A.

AU - Moon, Charles N.

AU - Scolaro, John A.

AU - Amirhekmat, Arya

AU - Leonard, Jordan

AU - Pogorzelski, David

AU - Bzovsky, Sofia

AU - Heels-Ansdell, Diane

AU - Szasz, Olivia P.

AU - Gallant, Jodi L.

AU - Della Rocca, Gregory J.

AU - Zura, Robert D.

AU - Hebden, Joan N.

AU - Patterson, Joseph T.

AU - Lee, Christopher

AU - O'Hara, Lyndsay M.

AU - Marvel, Debra

AU - Palmer, Jana E.

AU - Friedrich, Jeff

AU - D'Alleyrand, Jean Claude G.

AU - Rivera, Jessica C.

AU - Mossuto, Franca

AU - Schrank, Gregory M.

AU - Guyatt, Gordon

AU - Devereaux, P. J.

AU - Bhandari, Mohit

PY - 2024/2/1

Y1 - 2024/2/1

N2 - Background Studies evaluating surgical-site infection have had conflicting results with respect to the use of alcohol solutions containing iodine povacrylex or chlorhexidine gluconate as skin antisepsis before surgery to repair a fractured limb (i.e., an extremity fracture). Methods In a cluster-randomized, crossover trial at 25 hospitals in the United States and Canada, we randomly assigned hospitals to use a solution of 0.7% iodine povacrylex in 74% isopropyl alcohol (iodine group) or 2% chlorhexidine gluconate in 70% isopropyl alcohol (chlorhexidine group) as preoperative antisepsis for surgical procedures to repair extremity fractures. Every 2 months, the hospitals alternated interventions. Separate populations of patients with either open or closed fractures were enrolled and included in the analysis. The primary outcome was surgical-site infection, which included superficial incisional infection within 30 days or deep incisional or organ-space infection within 90 days. The secondary outcome was unplanned reoperation for fracture-healing complications. Results A total of 6785 patients with a closed fracture and 1700 patients with an open fracture were included in the trial. In the closed-fracture population, surgical-site infection occurred in 77 patients (2.4%) in the iodine group and in 108 patients (3.3%) in the chlorhexidine group (odds ratio, 0.74; 95% confidence interval [CI], 0.55 to 1.00; P=0.049). In the open-fracture population, surgical-site infection occurred in 54 patients (6.5%) in the iodine group and in 60 patients (7.3%) in the chlorhexidine group (odd ratio, 0.86; 95% CI, 0.58 to 1.27; P=0.45). The frequencies of unplanned reoperation, 1-year outcomes, and serious adverse events were similar in the two groups. Conclusions Among patients with closed extremity fractures, skin antisepsis with iodine povacrylex in alcohol resulted in fewer surgical-site infections than antisepsis with chlorhexidine gluconate in alcohol. In patients with open fractures, the results were similar in the two groups. (Funded by the Patient-Centered Outcomes Research Institute and the Canadian Institutes of Health Research; PREPARE ClinicalTrials.gov number, NCT03523962.)

AB - Background Studies evaluating surgical-site infection have had conflicting results with respect to the use of alcohol solutions containing iodine povacrylex or chlorhexidine gluconate as skin antisepsis before surgery to repair a fractured limb (i.e., an extremity fracture). Methods In a cluster-randomized, crossover trial at 25 hospitals in the United States and Canada, we randomly assigned hospitals to use a solution of 0.7% iodine povacrylex in 74% isopropyl alcohol (iodine group) or 2% chlorhexidine gluconate in 70% isopropyl alcohol (chlorhexidine group) as preoperative antisepsis for surgical procedures to repair extremity fractures. Every 2 months, the hospitals alternated interventions. Separate populations of patients with either open or closed fractures were enrolled and included in the analysis. The primary outcome was surgical-site infection, which included superficial incisional infection within 30 days or deep incisional or organ-space infection within 90 days. The secondary outcome was unplanned reoperation for fracture-healing complications. Results A total of 6785 patients with a closed fracture and 1700 patients with an open fracture were included in the trial. In the closed-fracture population, surgical-site infection occurred in 77 patients (2.4%) in the iodine group and in 108 patients (3.3%) in the chlorhexidine group (odds ratio, 0.74; 95% confidence interval [CI], 0.55 to 1.00; P=0.049). In the open-fracture population, surgical-site infection occurred in 54 patients (6.5%) in the iodine group and in 60 patients (7.3%) in the chlorhexidine group (odd ratio, 0.86; 95% CI, 0.58 to 1.27; P=0.45). The frequencies of unplanned reoperation, 1-year outcomes, and serious adverse events were similar in the two groups. Conclusions Among patients with closed extremity fractures, skin antisepsis with iodine povacrylex in alcohol resulted in fewer surgical-site infections than antisepsis with chlorhexidine gluconate in alcohol. In patients with open fractures, the results were similar in the two groups. (Funded by the Patient-Centered Outcomes Research Institute and the Canadian Institutes of Health Research; PREPARE ClinicalTrials.gov number, NCT03523962.)

KW - Bacterial Infections

KW - Infectious Disease

KW - Infectious Disease General

KW - Orthopedics

KW - Orthopedics General

KW - Surgery

KW - Surgery General

UR - http://www.scopus.com/inward/record.url?scp=85184768746&partnerID=8YFLogxK

U2 - 10.1056/NEJMoa2307679

DO - 10.1056/NEJMoa2307679

M3 - Article

AN - SCOPUS:85184768746

SN - 0028-4793

VL - 390

SP - 409

EP - 420

JO - New England Journal of Medicine

JF - New England Journal of Medicine

IS - 5

ER -

Skin Antisepsis before Surgical Fixation of Extremity Fractures.

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Keywords

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