InfectionOrthopedicsNCT03551561
Measures for the Prevention of Surgical Site Infection
A study testing CSAAC and CSAC in people with Infection, run by Universidade do Vale do Sapucai at 1 site in Brazil.
Trial summary
Among the causes associated with infection of hospitalized patients, surgical site infection is a complication that is potentially associated with any type of surgical procedure, it also represents an expressive burden in terms of morbidity and mortality, as well as additional costs for health care systems around the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infection
- What is being tested?
- CSAAC and CSAC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Jun 2017to 7 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients both males and females; older than 18 years old who will undergo orthopaedic surgical procedures;
Who cannot join
- patients who do not follow the medical guidelines; that are non-collaborative and / or do not sign the terms of consent.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade do Vale do Sapucai
Pouso Alegre, Minas Gerais, 37.550-000
About this study
Official title: Antisepsis Techniques in Orthopedic Surgical Procedures: a Comparative Study
Among the causes associated with infection of hospitalized patients, surgical site infection is a complication that is potentially associated with any type of surgical procedure, it also represents an expressive burden in terms of morbidity and mortality, as well as additional costs for health care systems around the world. It is regarded that the efficiency of the pre, per, and postoperative skin preparation depends on both the adopted antiseptic and the application method, with Chlorhexidine currently being the most used drug in such preparation. However, the manner, timing, or timing of cutaneous antisepsis action is unclear. Objective: Comparing antisepsis techniques using chlorhexidine-based soap associated with ethyl alcohol and alcoholic chlorhexidine versus chlorhexidine-based soap associated with alcoholic chlorhexidine, in surgical orthopedic procedures.
Read the detailed description
Among the causes associated with infection of hospitalized patients, surgical site infection is a complication that is potentially associated with any type of surgical procedure, it also represents an expressive burden in terms of morbidity and mortality, as well as additional costs for health care systems around the world. It is regarded that the efficiency of the pre, per, and postoperative skin preparation depends on both the adopted antiseptic and the application method, with Chlorhexidine currently being the most used drug in such preparation. However, the manner, timing, or timing of cutaneous antisepsis action is unclear. Objective: Comparing antisepsis techniques using chlorhexidine-based soap associated with ethyl alcohol and alcoholic chlorhexidine versus chlorhexidine-based soap associated with alcoholic chlorhexidine, in surgical orthopedic procedures. Methods: It is a primary, randomized, analytical and single-center clinical trial, consisting of 170 patients, which were distributed between 2 randomized groups, where Chlorhexidine-based Soap + Alcoholic Chlorhexidine were tested on the group CSAC and Chlorhexidine-based Soap + 70% Ethyl Alcohol + Alcoholic Chlorhexidine were tested on the group CSAAC. Cultures were performed in the Mannitol and EMB (Eosin Methylene Blue) media after being collected at the pre, post-skin preparation and end of the surgical procedure
- Conditions
- Infection
- Being tested
- CSAAC, CSAC
- Keywords
- Chlorhexidine, Infection, Orthopedics, Surgical rooms, Antisepsis, Surgical Procedures.
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSAACDrug
Also called chlorhexidine-based sopa+70% alcool+alcoholic chlorhexidine
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.
CSACDrug
Also called chlorhexidine-based sopa + alcoholic chlorhexidine
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.
| Study group | Role | What they receive |
|---|---|---|
| CSAAC group | Active comparator | 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. Receives: Drug: CSAAC; Drug: CSAC |
| CSAC group | Active comparator | 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. Receives: Drug: CSAAC; Drug: CSAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of bacterial skin colonization
Skin culture
Measured: about 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study start30 Jun 2017
- Primary completion7 Nov 2017
- Study completion7 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Vale do Sapucai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eugenio C Mendes, MD, Principal investigator, Universidade do Vale do Sapucai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03551561
- Sponsor's protocol ID
- Surgical Site Infection
- Acronym
- Orthopedics
- Status last verified
- May 2018
- First submitted
- 8 Apr 2018
- Last updated
- 11 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29551302Capen 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.
PubMed 8539055Charles 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.
PubMed 28790056Cheng 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.
PubMed 28832271Dicks 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.
PubMed 26391277Drakos MC, Murphy CI. Bracing versus casting in ankle fractures. Phys Sportsmed. 2014 Nov;42(4):60-70. doi: 10.3810/psm.2014.11.2092.
PubMed 25419889Duchman 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.
PubMed 28040399Ellenhorn 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.
PubMed 16256917George 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.
PubMed 28529860Glassman 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.
PubMed 8893444Hosseini 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.
PubMed 27090260Houang 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.
PubMed 6174590Kamel 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/
PubMed 24354038Lee 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.
PubMed 20969449Levi 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.
PubMed 9171176
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antisepsis Techniques in Orthopedic Surgical Procedures: a Comparative Study
- ClinicalTrials.gov ID
- NCT03551561
- Acronym / sponsor ID
- Orthopedics / Surgical Site Infection
- Conditions
- Infection
- Keywords
- Chlorhexidine, Infection, Orthopedics, Surgical rooms, Antisepsis, Surgical Procedures.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Universidade do Vale do SapucaiUniversity, hospital or other
- Study start
- 30 Jun 2017 (actual)
- Primary completion
- 7 Nov 2017 (actual)
- Study completion
- 7 Nov 2017 (actual)
- First posted
- 11 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Among the causes associated with infection of hospitalized patients, surgical site infection is a complication that is potentially associated with any type of surgical procedure, it also represents an expressive burden in terms of morbidity and mortality, as well as additional costs for health care systems around the world. It is regarded that the efficiency of the pre, per, and postoperative skin preparation depends on both the adopted antiseptic and the application method, with Chlorhexidine currently being the most used drug in such preparation. However, the manner, timing, or timing of cutaneous antisepsis action is unclear. Objective: Comparing antisepsis techniques using chlorhexidine-based soap associated with ethyl alcohol and alcoholic chlorhexidine versus chlorhexidine-based soap associated with alcoholic chlorhexidine, in surgical orthopedic procedures.
Detailed description
Among the causes associated with infection of hospitalized patients, surgical site infection is a complication that is potentially associated with any type of surgical procedure, it also represents an expressive burden in terms of morbidity and mortality, as well as additional costs for health care systems around the world. It is regarded that the efficiency of the pre, per, and postoperative skin preparation depends on both the adopted antiseptic and the application method, with Chlorhexidine currently being the most used drug in such preparation. However, the manner, timing, or timing of cutaneous antisepsis action is unclear. Objective: Comparing antisepsis techniques using chlorhexidine-based soap associated with ethyl alcohol and alcoholic chlorhexidine versus chlorhexidine-based soap associated with alcoholic chlorhexidine, in surgical orthopedic procedures. Methods: It is a primary, randomized, analytical and single-center clinical trial, consisting of 170 patients, which were distributed between 2 randomized groups, where Chlorhexidine-based Soap + Alcoholic Chlorhexidine were tested on the group CSAC and Chlorhexidine-based Soap + 70% Ethyl Alcohol + Alcoholic Chlorhexidine were tested on the group CSAAC. Cultures were performed in the Mannitol and EMB (Eosin Methylene Blue) media after being collected at the pre, post-skin preparation and end of the surgical procedure
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CSAAC group | Active comparator | Drug: CSAAC, Drug: CSACThe 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. |
| CSAC group | Active comparator | Drug: CSAAC, Drug: CSACThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients both males and females; older than 18 years old who will undergo orthopaedic surgical procedures;
Key exclusion criteria (1 listed)
- patients who do not follow the medical guidelines; that are non-collaborative and / or do not sign the terms of consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CSAACAlso: chlorhexidine-based sopa+70% alcool+alcoholic chlorhexidineSkin 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. | Drug | CSAAC group, CSAC group |
| CSACAlso: chlorhexidine-based sopa + alcoholic chlorhexidineSkin 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. | Drug | CSAAC group, CSAC group |
Primary outcome
Incidence of bacterial skin colonization
Time frame: about 6 hours
Skin culture
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2018.
- Background: PubMed 29551302Bohl 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.
- Background: PubMed 8539055Capen 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.
- Background: PubMed 28790056Charles 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.
- Background: PubMed 28832271Cheng 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.
- Background: PubMed 26391277Dicks 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.
- Background: PubMed 25419889Drakos MC, Murphy CI. Bracing versus casting in ankle fractures. Phys Sportsmed. 2014 Nov;42(4):60-70. doi: 10.3810/psm.2014.11.2092.
- Background: PubMed 28040399Duchman 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.
- Background: PubMed 16256917Ellenhorn 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.
- Background: PubMed 28529860George 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.
- Background: PubMed 8893444Glassman 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.
- Background: PubMed 27090260Hosseini 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.
- Background: PubMed 6174590Houang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eugenio C Mendes, MD principal investigator
Universidade do Vale do Sapucai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CSAAC and CSAC in people with Infection, run by Universidade do Vale do Sapucai at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of bacterial skin colonization (time frame: about 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03551561, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2018.