Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
170 participants
INTERVENTIONAL
2017-06-30
2017-11-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Surgical and Non-surgical Infections of Neurosurgical Patient: Before-after Cohort Study
NCT03759652
De-Implementation of Unnecessary Surgical Antibiotic Prophylaxis in Children
NCT04366440
The Use of 2% Chlorhexidine Gluconate Impregnated Cloth Bathing in Preoperative Skin Preparation
NCT03813693
Intraoperative Hygiene Measures and Surgical Site Infections
NCT00555815
Surgical Wound Infections After Vascular Surgery: Prospective Multicenter Trial
NCT00812747
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CSAAC group
The CSAAC group (chlorhexidine-based soap + ethyl alcohol + alcoholic chlorhexidine): skin preparation process with 4% chlorhexidine-based soap for a period of 5 minutes, followed by a sterile and soaked with 70% alcohol compress. After removing the chlorhexidine-based soap excess, antisepsis was performed with alcoholic chlorhexidine and surgical drapes and gowns. Cultures were performed in the mannitol and EMB (Eosin Methylene Blue) media after being collected at the pre-skin preparation, post-skin preparation process and end of the surgical procedure.
CSAAC
Skin preparation with 4% chlorhexidine-based soap for a period of 5 minutes, followed by a sterile and soaked with 70% alcohol compress. After removing the chlorhexidine-based soap excess, antisepsis was performed with alcoholic chlorhexidine and surgical drapes and gowns.
CSAC
Skin preparation with 4% chlorhexidine-based soap for a period of 5 minutes and the of a simple, dry and sterile compress to remove the excess. After removing the excess, antisepsis was performed with alcoholic chlorhexidine and surgical drapes and gowns.
CSAC group
The CSAC group (chlorhexidine-based soap + alcoholic chlorhexidine): skin preparation process with 4% chlorhexidine-based soap for a period of 5 minutes and the of a simple, dry and sterile compress to remove the excess. After removing the excess, antisepsis was performed with alcoholic chlorhexidine and surgical drapes and gowns. Cultures were performed in the mannitol and EMB media after being collected at the pre-skin preparation, post-skin preparation process and end of the surgical procedure.
CSAAC
Skin preparation with 4% chlorhexidine-based soap for a period of 5 minutes, followed by a sterile and soaked with 70% alcohol compress. After removing the chlorhexidine-based soap excess, antisepsis was performed with alcoholic chlorhexidine and surgical drapes and gowns.
CSAC
Skin preparation with 4% chlorhexidine-based soap for a period of 5 minutes and the of a simple, dry and sterile compress to remove the excess. After removing the excess, antisepsis was performed with alcoholic chlorhexidine and surgical drapes and gowns.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CSAAC
Skin preparation with 4% chlorhexidine-based soap for a period of 5 minutes, followed by a sterile and soaked with 70% alcohol compress. After removing the chlorhexidine-based soap excess, antisepsis was performed with alcoholic chlorhexidine and surgical drapes and gowns.
CSAC
Skin preparation with 4% chlorhexidine-based soap for a period of 5 minutes and the of a simple, dry and sterile compress to remove the excess. After removing the excess, antisepsis was performed with alcoholic chlorhexidine and surgical drapes and gowns.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Universidade do Vale do Sapucai
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Eugenio C Mendes, MD
Role: PRINCIPAL_INVESTIGATOR
Universidade do Vale do Sapucai
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Universidade do Vale do Sapucai
Pouso Alegre, Minas Gerais, Brazil
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Bohl DD, Ondeck NT, Darrith B, Hannon CP, Fillingham YA, Della Valle CJ. Impact of Operative Time on Adverse Events Following Primary Total Joint Arthroplasty. J Arthroplasty. 2018 Jul;33(7):2256-2262.e4. doi: 10.1016/j.arth.2018.02.037. Epub 2018 Feb 17.
Capen DA, Calderone RR, Green A. Perioperative risk factors for wound infections after lower back fusions. Orthop Clin North Am. 1996 Jan;27(1):83-6.
Charles D, Heal CF, Delpachitra M, Wohlfahrt M, Kimber D, Sullivan J, Browning S, Saednia S, Hardy A, Banks J, Buttner P. Alcoholic versus aqueous chlorhexidine for skin antisepsis: the AVALANCHE trial. CMAJ. 2017 Aug 8;189(31):E1008-E1016. doi: 10.1503/cmaj.161460.
Cheng H, Chen BP, Soleas IM, Ferko NC, Cameron CG, Hinoul P. Prolonged Operative Duration Increases Risk of Surgical Site Infections: A Systematic Review. Surg Infect (Larchmt). 2017 Aug/Sep;18(6):722-735. doi: 10.1089/sur.2017.089.
Dicks KV, Baker AW, Durkin MJ, Anderson DJ, Moehring RW, Chen LF, Sexton DJ, Weber DJ, Lewis SS. Short Operative Duration and Surgical Site Infection Risk in Hip and Knee Arthroplasty Procedures. Infect Control Hosp Epidemiol. 2015 Dec;36(12):1431-6. doi: 10.1017/ice.2015.222. Epub 2015 Sep 22.
Drakos MC, Murphy CI. Bracing versus casting in ankle fractures. Phys Sportsmed. 2014 Nov;42(4):60-70. doi: 10.3810/psm.2014.11.2092.
Duchman KR, Pugely AJ, Martin CT, Gao Y, Bedard NA, Callaghan JJ. Operative Time Affects Short-Term Complications in Total Joint Arthroplasty. J Arthroplasty. 2017 Apr;32(4):1285-1291. doi: 10.1016/j.arth.2016.12.003. Epub 2016 Dec 14.
Ellenhorn JD, Smith DD, Schwarz RE, Kawachi MH, Wilson TG, McGonigle KF, Wagman LD, Paz IB. Paint-only is equivalent to scrub-and-paint in preoperative preparation of abdominal surgery sites. J Am Coll Surg. 2005 Nov;201(5):737-41. doi: 10.1016/j.jamcollsurg.2005.05.023. Epub 2005 Aug 31.
George J, Klika AK, Higuera CA. Use of Chlorhexidine Preparations in Total Joint Arthroplasty. J Bone Jt Infect. 2017 Jan 1;2(1):15-22. doi: 10.7150/jbji.16934. eCollection 2017.
Glassman SD, Dimar JR, Puno RM, Johnson JR. Salvage of instrumental lumbar fusions complicated by surgical wound infection. Spine (Phila Pa 1976). 1996 Sep 15;21(18):2163-9. doi: 10.1097/00007632-199609150-00021.
Hosseini P, Mundis GM Jr, Eastlack R, Nourian A, Pawelek J, Nguyen S, Akbarnia BA. Do Longer Surgical Procedures Result in Greater Contamination of Surgeons' Hands? Clin Orthop Relat Res. 2016 Jul;474(7):1707-13. doi: 10.1007/s11999-016-4832-1. Epub 2016 Apr 18.
Houang ET, Buckley R, Smith M, O'Riordan SM. Survival of Pseudomonas aeruginosa in plaster of Paris. J Hosp Infect. 1981 Sep;2(3):231-5. doi: 10.1016/0195-6701(81)90042-6. No abstract available.
Kamel C, McGahan L, Mierzwinski-Urban M, Embil J. Preoperative Skin Antiseptic Preparations and Application Techniques for Preventing Surgical Site Infections: A Systematic Review of the Clinical Evidence and Guidelines [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2011 Jun. Available from http://www.ncbi.nlm.nih.gov/books/NBK174549/
Lee I, Agarwal RK, Lee BY, Fishman NO, Umscheid CA. Systematic review and cost analysis comparing use of chlorhexidine with use of iodine for preoperative skin antisepsis to prevent surgical site infection. Infect Control Hosp Epidemiol. 2010 Dec;31(12):1219-29. doi: 10.1086/657134. Epub 2010 Oct 22.
Levi AD, Dickman CA, Sonntag VK. Management of postoperative infections after spinal instrumentation. J Neurosurg. 1997 Jun;86(6):975-80. doi: 10.3171/jns.1997.86.6.0975.
Martinez J, Macias JH, Arreguin V, Alvarez JA, Macias AE, Mosqueda-Gomez JL. Isopropyl alcohol is as efficient as chlorhexidine to prevent contamination of blood cultures. Am J Infect Control. 2017 Apr 1;45(4):350-353. doi: 10.1016/j.ajic.2016.11.027. Epub 2017 Jan 12.
Mears SC, Dinah AF, Knight TA, Frassica FJ, Belkoff SM. Visibility of surgical site marking after preoperative skin preparation. Eplasty. 2008 Jul 16;8:e35.
Ovaska MT, Makinen TJ, Madanat R, Huotari K, Vahlberg T, Hirvensalo E, Lindahl J. Risk factors for deep surgical site infection following operative treatment of ankle fractures. J Bone Joint Surg Am. 2013 Feb 20;95(4):348-53. doi: 10.2106/JBJS.K.01672.
Peel TN, Cheng AC, Buising KL, Dowsey MM, Choong PF. Alcoholic Chlorhexidine or Alcoholic Iodine Skin Antisepsis (ACAISA): protocol for cluster randomised controlled trial of surgical skin preparation for the prevention of superficial wound complications in prosthetic hip and knee replacement surgery. BMJ Open. 2014 May 15;4(5):e005424. doi: 10.1136/bmjopen-2014-005424.
Prottey C, Pryce NG. Hand cleansing and skin condition. A comparison of conventional soap washing and the use of alcohol-impregnated paper cloths. Int J Cosmet Sci. 1987 Apr;9(2):53-8. doi: 10.1111/j.1467-2494.1987.tb00462.x.
Reichel M, Heisig P, Kohlmann T, Kampf G. Alcohols for skin antisepsis at clinically relevant skin sites. Antimicrob Agents Chemother. 2009 Nov;53(11):4778-82. doi: 10.1128/AAC.00582-09. Epub 2009 Sep 8.
Ridgeway S, Wilson J, Charlet A, Kafatos G, Pearson A, Coello R. Infection of the surgical site after arthroplasty of the hip. J Bone Joint Surg Br. 2005 Jun;87(6):844-50. doi: 10.1302/0301-620X.87B6.15121.
Roy-Camille R, Saillant G, Mazel C. Internal fixation of the lumbar spine with pedicle screw plating. Clin Orthop Relat Res. 1986 Feb;(203):7-17.
Saltzman MD, Nuber GW, Gryzlo SM, Marecek GS, Koh JL. Efficacy of surgical preparation solutions in shoulder surgery. J Bone Joint Surg Am. 2009 Aug;91(8):1949-53. doi: 10.2106/JBJS.H.00768.
Savage JW, Anderson PA. An update on modifiable factors to reduce the risk of surgical site infections. Spine J. 2013 Sep;13(9):1017-29. doi: 10.1016/j.spinee.2013.03.051. Epub 2013 May 24.
Schepers T, De Vries MR, Van Lieshout EM, Van der Elst M. The timing of ankle fracture surgery and the effect on infectious complications; a case series and systematic review of the literature. Int Orthop. 2013 Mar;37(3):489-94. doi: 10.1007/s00264-012-1753-9. Epub 2013 Jan 4.
Segal CG, Anderson JJ. Preoperative skin preparation of cardiac patients. AORN J. 2002 Nov;76(5):821-8. doi: 10.1016/s0001-2092(06)61035-1.
Veiga DF, Damasceno CAV, Veiga-Filho J, Figueiras RG, Vieira RB, Florenzano FH, Juliano Y, Ferreira LM. Povidone iodine versus chlorhexidine in skin antisepsis before elective plastic surgery procedures: a randomized controlled trial. Plast Reconstr Surg. 2008 Nov;122(5):170e-171e. doi: 10.1097/PRS.0b013e318186cd7f. No abstract available.
Vioreanu M, Dudeney S, Hurson B, Kelly E, O'Rourke K, Quinlan W. Early mobilization in a removable cast compared with immobilization in a cast after operative treatment of ankle fractures: a prospective randomized study. Foot Ankle Int. 2007 Jan;28(1):13-9. doi: 10.3113/FAI.2007.0003.
Weed S, Bastek JA, Sammel MD, Beshara M, Hoffman S, Srinivas SK. Comparing postcesarean infectious complication rates using two different skin preparations. Obstet Gynecol. 2011 May;117(5):1123-1129. doi: 10.1097/AOG.0b013e3182118e98.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Surgical Site Infection
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.