Pre-operative Alcohol Skin Solutions in Fractured Extremities
Summary
The prevention of infection is an important goal influencing peri-operative care of extremity fracture patients. Standard practice in the operative management of extremity fractures includes sterile technique and pre-operative skin preparation with an antiseptic solution. The available solutions kill bacteria and decrease the quantity of native skin flora, thereby decreasing surgical site infection (SSI). While there is extensive guidance on specific procedures for prophylactic antibiotic use and standards for sterile technique, the evidence regarding the choice of antiseptic skin preparation solution is very limited for extremity fracture surgery.
Timeline
- Start
- 2018-08-21
- Primary completion
- 2023-03-15
- Completion
- 2024-02-02
Outcome
Mixed primary results
paper 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. PMID 38294973 ↗
paper 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). PMID 38294973 ↗
paper 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). PMID 38294973 ↗
Publications
- PREP-IT Investigators; 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 3rd, Potter GD, 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 JG, Rivera JC, Mossuto F, Schrank GM, Guyatt G, Devereaux PJ, Bhandari M; The PREP-IT Investigators. Skin Antisepsis before Surgical Fixation of Extremity Fractures. N Engl J Med. 2024 Feb 1;390(5):409-420. doi: 10.1056/NEJMoa2307679.
- Boissonneault A, O Hara N, Pogorzelski D, Marchand L, Higgins T, Gitajn L, Gage MJ, Natoli RM, Sharma I, Pierrie S, O'Toole RV, Sprague S, Slobogean G; PREP-IT Investigators*. The impact of heterotopic ossification prophylaxis after surgical fixation of acetabular fractures: national treatment patterns and related outcomes. Injury. 2023 Mar 6:S0020-1383(23)00197-3. doi: 10.1016/j.injury.2023.03.001. Online ahead of print.
- Sprague S, Scott T, Dodds S, Pogorzelski D, McKay P, Harris AD, Wood A, Thabane L, Bhandari M, Mehta S, Gaski G, Boulton C, Marcano-Fernandez F, Guerra-Farfan E, Hebden J, O'Hara LM, Slobogean GP; PREP-IT Investigators. Cluster identification, selection, and description in cluster randomized crossover trials: the PREP-IT trials. Trials. 2020 Aug 12;21(1):712. doi: 10.1186/s13063-020-04611-9.
- Program of Randomized Trials to Evaluate Pre-operative Antiseptic Skin Solutions in Orthopaedic Trauma (PREP-IT) Investigators; Slobogean GP, Sprague S, Wells J, Bhandari M, Rojas A, Garibaldi A, Wood A, Howe A, Harris AD, Petrisor BA, Mullins DC, Pogorzelski D, Marvel D, Heels-Ansdell D, Mossuto F, Grissom F, Del Fabbro G, Guyatt GH, Della Rocca GJ, Demyanovich HK, Gitajn IL, Palmer J, D'Alleyrand JC, Friedrich J, Rivera J, Hebden J, Rudnicki J, Fowler J, Jeray KJ, Thabane L, Marchand L, O'Hara LM, Joshi MG, Talbot M, Camara M, Szasz OP, O'Hara NN, McKay P, Devereaux PJ, O'Toole RV, Zura R, Morshed S, Dodds S, Li S, Tanner SL, Scott T, Nguyen U. Effectiveness of Iodophor vs Chlorhexidine Solutions for Surgical Site Infections and Unplanned Reoperations for Patients Who Underwent Fracture Repair: The PREP-IT Master Protocol. JAMA Netw Open. 2020 Apr 1;3(4):e202215. doi: 10.1001/jamanetworkopen.2020.2215.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ChloraPrep | Other / unclassified | 2 % | Topical |
| Subject | Iodine Povacrylex | Other / unclassified | 0.7 % | Topical |
Indications
No indication recorded.