Surgical Site InfectionPhase 4NCT01790529
Randomized Controlled Trial to Evaluate the Optimal Timing of Surgical Antimicrobial Prophylaxis
A Phase 4 study testing Early administration of SAP (Cefuroxime (plus metronidazole in colorectal surgery)) in anesthetic room (75 to 30 minutes prior to skin incision) and Late administration of SAP (Cefuroxime (plus metronidazole in colorectal surgery)) in the operating theatre (within 30 minutes prior to skin incision) in people with Surgical Site Infection, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Surgical site infections (SSI) are the most frequent hospital acquired infections in patients who underwent surgery. With regards to the increasing financial restraint in patient care, the socio-economic burden of SSI in the public health sector and its prevention gains in importance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Early administration of SAP (Cefuroxime (plus metronidazole in colorectal surgery)) in anesthetic room (75 to 30 minutes prior to skin incision) and Late administration of SAP (Cefuroxime (plus metronidazole in colorectal surgery)) in the operating theatre (within 30 minutes prior to skin incision)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2013to Sep 2016
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Inpatient visceral, vascular and trauma procedures
- SAP indicated according to clinical standards (CDC guidelines for surgical wound classification)
- informed consent
Who cannot join
- Contraindication for study drugs
- Pre-existing antibiotic therapy within 14 days of surgery
- Any doubt that patients can make the decision to participate fully informed due to cognitive impairment, such as in critically ill or demented patients.
- Emergency procedures with planned incision within 2 hours after the surgeon indicated the procedure
- Participation in other studies that could potentially interfere with the present one (according to the ethics committee)
- Combined surgery including surgical subspecialties other than the above mentioned
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel
Basel, Canton of Basel-City, 4031
About this study
Surgical site infections (SSI) are the most frequent hospital acquired infections in patients who underwent surgery. With regards to the increasing financial restraint in patient care, the socio-economic burden of SSI in the public health sector and its prevention gains in importance.
The prophylactic application of antibiotics (surgical antimicrobial prophylaxis, SAP) prior to the skin incision significantly reduces the risk of SSI, but the correct time point of drug administration remains unclear. Most studies recommend application of SAP directly prior to skin incision. Other studies, however, suggest that this is too late and more time between administration of the SAP and skin incision is necessary for optimal SSI prevention. A large cohort study in Switzerland concluded that SAP should be applied between 74 and 30 minutes prior to skin incision.
Read more
Due to the obvious importance of this controversy, we want to answer this question with a clinical study (randomized controlled trial, RCT) at the University Hospital of Basel and the Cantonal Hospital of Aarau. We plan to investigate two administration strategies according to the timing of the SAP. Strategy A will consist of SAP application in the anesthetic room located in front of the actual operating theatre, where the patient gets anesthesia. Therefore, the application of SAP will take place early, approximately between 75 and 30 minutes prior to skin incision. In strategy B we will apply SAP in the operating theatre, which on average occurs later (approximately within the last 30 minutes before skin incision).
We test the hypothesis that strategy A is more effective in preventing SSI than strategy B. We will include a total of 5000 patients in abdominal, vascular and trauma surgery (2500 at each study site and 2500 per study group). All patients will be followed in the hospital for SSI occurrence. Additionally, all patients will be interviewed by telephone after hospital discharge at a defined follow-up period of 30 days (1 year if an implant is in place, such as hip endoprosthesis or meshes). We expect this study to be completed within approximately 3 years.
Read the detailed description
Additionally, the association between the following pre-defined variables and the occurence of SSI, mortality, morbidity and length of hospital stay (LOS) will be investigated:
- laparoscopy
- tutorial assistance during operation
- obesity (Body Mass Index, BMI)
- preoperative Virtual Reality (VR) training
- Adherence to Enhanced Recovery After Surgery (ERAS) concept
- smoking status
- perioperative blood glucose levels
- preoperative levels of HbA1c
- intensified insulin resistance as measured by Homeostasis Model Assessment (HOMA) and quantitative insulin-sensitivity check index (QUICKI)
- type of diabetes (IDDM vs. NIDDM)
- intraoperative Hypothermia (body core temperature)
- Lack of adherence to the principles of asepsis during surgery
- surgical experience
- patients age
- Malnutrition, measured by Hypalbuminaemia
- emergency operations
- immunosuppression and steroids
- Predictive value of Procalcitonin
- American Society of Anesthesiologists (ASA) classification
- intraoperative blood transfusion
- preoperative wound class
Amendments:
The following changes were made to the study protocol according to amendments approved by the local ethics committee:
- As of April 22nd, 2013, or the 222. patient randomized at the University Hospital Basel, the time the SAP infusion STARTED was recorded instead of the time that it ENDED. The decision to change this important parameter was taken in order to make results of this trial more comparable to those of other published studies.
- In the original study protocol it was planned to provide each randomized patient with a patient's diary to record signs of SSI. This was abandoned for limited benefit and in order to minimize patients' time and effort.
- Patients who undergo combined surgery (by one of the participating surgical specialties plus by a non participating specialty) shall not be included in this trial as outcomes (SSI) could be difficult to correlate to one or another part of surgery. This had not been specified as an exclusion criterion in the original study protocol.
- Patients' information sheets and informed consents in one of the languages other than German were only approved by the local ethics committees by May 15th, 2013.
- As per ethics committees regulations, patients can only be included in more than one clinical trials under specific circumstances. Therefore only a limited percentage of patients that are already included in other studies can still be included for this trial. However, overall, this only excludes a very limited number of potentially includable patients.
The following additional amendments were authorized by the ethics committees on August 9th, 2014:
- Version 4 of the patients' information and the written consent form. In these new versions, patients are specifically asked for permission to review their general practitioners' notes concerning potential SSI, for planned follow up as well as in case of readmission to hospital. This is specified in the study protocol, but had not been specifically mentioned in the patients' information and consent forms. This change is also intended to significantly decrease the number of patients lost to follow up as it proved difficult to contact some patients by telephone.
- Conditions
- Surgical Site Infection
- Being tested
- Early administration of SAP (Cefuroxime (plus metronidazole in colorectal surgery)) in anesthetic room (75 to 30 minutes prior to skin incision), Late administration of SAP (Cefuroxime (plus metronidazole in colorectal surgery)) in the operating theatre (within 30 minutes prior to skin incision)
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early administration of SAP (Cefuroxime (plus metronidazole in colorectal surgery)) in anesthetic room (75 to 30 minutes prior to skin incision)Procedure or surgery
Late administration of SAP (Cefuroxime (plus metronidazole in colorectal surgery)) in the operating theatre (within 30 minutes prior to skin incision)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Early Prophylaxis | Experimental | Early administration of SAP (Cefuroxime (plus metronidazole in colorectal surgery)) in anesthetic room (75 to 30 minutes prior to skin incision) Receives: Procedure: Early administration of SAP (Cefuroxime (plus metronidazole in colorectal surgery)) in anesthetic room (75 to 30 minutes prior to skin incision) |
| Late Prophylaxis | Active comparator | Late administration of SAP (Cefuroxime (plus metronidazole in colorectal surgery)) in the operating theatre (within 30 minutes prior to skin incision) Receives: Procedure: Late administration of SAP (Cefuroxime (plus metronidazole in colorectal surgery)) in the operating theatre (within 30 minutes prior to skin incision) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site Infection (SSI)
Surgical Site Infection within 30 days after index surgery
Measured: 30 days
Secondary outcomes (6)
All-cause 30 day mortality
Measured: 30 days
Length of hospital stay
Measured: 1 year
Economic burden of SSI
Measured: 1 year
Nosocomial infections
Measured: 1 year
In-hospital complications
according to the Clavien-Dindo-Classification
Measured: 1 year
Surgical Site Infection (SSI)
Surgical Site Infection within 1 year after surgery only for implant surgeries
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionJul 2015
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Cantonal Hospital of Aarau, Switzerland
- Responsible party
- Sponsor
- Investigators
- Walter P. Weber, MD, Principal investigator, University Hospital Basel, Basel 4031 Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01790529
- Sponsor's protocol ID
- SSI-19/12
- Status last verified
- Sep 2016
- First submitted
- 5 Feb 2013
- Last updated
- 29 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cristino MA, Nakano LC, Vasconcelos V, Correia RM, Flumignan RL. Prevention of infection in aortic or aortoiliac peripheral arterial reconstruction. Cochrane Database Syst Rev. 2025 Apr 22;4(4):CD015192. doi: 10.1002/14651858.CD015192.pub2.
PubMed 40260835Kopp Lugli A, Marti WR, Salm L, Mujagic E, Bundi M, von Strauss M, Bucheli Laffer E, Landin J, Fux CA, Coslovsky M, Weber WP, Kindler C. The Role of HbA1c as a Positive Perioperative Predictor of Surgical Site and Other Postoperative Infections: An Explorative Analysis in Patients Undergoing Minor to Major Surgery. World J Surg. 2022 Feb;46(2):391-399. doi: 10.1007/s00268-021-06368-x. Epub 2021 Nov 8.
PubMed 34750659Weber WP, Mujagic E, Zwahlen M, Bundi M, Hoffmann H, Soysal SD, Kraljevic M, Delko T, von Strauss M, Iselin L, Da Silva RXS, Zeindler J, Rosenthal R, Misteli H, Kindler C, Muller P, Saccilotto R, Lugli AK, Kaufmann M, Gurke L, von Holzen U, Oertli D, Bucheli-Laffer E, Landin J, Widmer AF, Fux CA, Marti WR. Timing of surgical antimicrobial prophylaxis: a phase 3 randomised controlled trial. Lancet Infect Dis. 2017 Jun;17(6):605-614. doi: 10.1016/S1473-3099(17)30176-7. Epub 2017 Apr 3.
PubMed 28385346Mujagic E, Zwimpfer T, Marti WR, Zwahlen M, Hoffmann H, Kindler C, Fux C, Misteli H, Iselin L, Lugli AK, Nebiker CA, von Holzen U, Vinzens F, von Strauss M, Reck S, Kraljevic M, Widmer AF, Oertli D, Rosenthal R, Weber WP. Evaluating the optimal timing of surgical antimicrobial prophylaxis: study protocol for a randomized controlled trial. Trials. 2014 May 24;15:188. doi: 10.1186/1745-6215-15-188.
PubMed 24885132
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Evaluate the Optimal Timing of Surgical Antimicrobial Prophylaxis
- ClinicalTrials.gov ID
- NCT01790529
- Acronym / sponsor ID
- SSI-19/12
- Conditions
- Surgical Site Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,000 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Cantonal Hospital of Aarau, Switzerland
- Study start
- Feb 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 13 Feb 2013 (estimated)
- 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.
Surgical site infections (SSI) are the most frequent hospital acquired infections in patients who underwent surgery. With regards to the increasing financial restraint in patient care, the socio-economic burden of SSI in the public health sector and its prevention gains in importance.
The prophylactic application of antibiotics (surgical antimicrobial prophylaxis, SAP) prior to the skin incision significantly reduces the risk of SSI, but the correct time point of drug administration remains unclear. Most studies recommend application of SAP directly prior to skin incision. Other studies, however, suggest that this is too late and more time between administration of the SAP and skin incision is necessary for optimal SSI prevention. A large cohort study in Switzerland concluded that SAP should be applied between 74 and 30 minutes prior to skin incision.
Due to the obvious importance of this controversy, we want to answer this question with a clinical study (randomized controlled trial, RCT) at the University Hospital of Basel and the Cantonal Hospital of Aarau. We plan to investigate two administration strategies according to the timing of the SAP. Strategy A will consist of SAP application in the anesthetic room located in front of the actual operating theatre, where the patient gets anesthesia. Therefore, the application of SAP will take place early, approximately between 75 and 30 minutes prior to skin incision. In strategy B we will apply SAP in the operating theatre, which on average occurs later (approximately within the last 30 minutes before skin incision).
We test the hypothesis that strategy A is more effective in preventing SSI than strategy B. We will include a total of 5000 patients in abdominal, vascular and trauma surgery (2500 at each study site and 2500 per study group). All patients will be followed in the hospital for SSI occurrence. Additionally, all patients will be interviewed by telephone after hospital discharge at a defined follow-up period of 30 days (1 year if an implant is in place, such as hip endoprosthesis or meshes). We expect this study to be completed within approximately 3 years.
Detailed description
Additionally, the association between the following pre-defined variables and the occurence of SSI, mortality, morbidity and length of hospital stay (LOS) will be investigated:
- laparoscopy
- tutorial assistance during operation
- obesity (Body Mass Index, BMI)
- preoperative Virtual Reality (VR) training
- Adherence to Enhanced Recovery After Surgery (ERAS) concept
- smoking status
- perioperative blood glucose levels
- preoperative levels of HbA1c
- intensified insulin resistance as measured by Homeostasis Model Assessment (HOMA) and quantitative insulin-sensitivity check index (QUICKI)
- type of diabetes (IDDM vs. NIDDM)
- intraoperative Hypothermia (body core temperature)
- Lack of adherence to the principles of asepsis during surgery
- surgical experience
- patients age
- Malnutrition, measured by Hypalbuminaemia
- emergency operations
- immunosuppression and steroids
- Predictive value of Procalcitonin
- American Society of Anesthesiologists (ASA) classification
- intraoperative blood transfusion
- preoperative wound class
Amendments:
The following changes were made to the study protocol according to amendments approved by the local ethics committee:
- As of April 22nd, 2013, or the 222. patient randomized at the University Hospital Basel, the time the SAP infusion STARTED was recorded instead of the time that it ENDED. The decision to change this important parameter was taken in order to make results of this trial more comparable to those of other published studies.
- In the original study protocol it was planned to provide each randomized patient with a patient's diary to record signs of SSI. This was abandoned for limited benefit and in order to minimize patients' time and effort.
- Patients who undergo combined surgery (by one of the participating surgical specialties plus by a non participating specialty) shall not be included in this trial as outcomes (SSI) could be difficult to correlate to one or another part of surgery. This had not been specified as an exclusion criterion in the original study protocol.
- Patients' information sheets and informed consents in one of the languages other than German were only approved by the local ethics committees by May 15th, 2013.
- As per ethics committees regulations, patients can only be included in more than one clinical trials under specific circumstances. Therefore only a limited percentage of patients that are already included in other studies can still be included for this trial. However, overall, this only excludes a very limited number of potentially includable patients.
The following additional amendments were authorized by the ethics committees on August 9th, 2014:
- Version 4 of the patients' information and the written consent form. In these new versions, patients are specifically asked for permission to review their general practitioners' notes concerning potential SSI, for planned follow up as well as in case of readmission to hospital. This is specified in the study protocol, but had not been specifically mentioned in the patients' information and consent forms. This change is also intended to significantly decrease the number of patients lost to follow up as it proved difficult to contact some patients by telephone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Prophylaxis | Experimental | Procedure: Early administration of SAP (Cefuroxime (plus metronidazole in colorectal surgery)) in anesthetic room (75 to 30 minutes prior to skin incision)Early administration of SAP (Cefuroxime (plus metronidazole in colorectal surgery)) in anesthetic room (75 to 30 minutes prior to skin incision) |
| Late Prophylaxis | Active comparator | Procedure: Late administration of SAP (Cefuroxime (plus metronidazole in colorectal surgery)) in the operating theatre (within 30 minutes prior to skin incision)Late administration of SAP (Cefuroxime (plus metronidazole in colorectal surgery)) in the operating theatre (within 30 minutes prior to skin incision) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Inpatient visceral, vascular and trauma procedures
- SAP indicated according to clinical standards (CDC guidelines for surgical wound classification)
- informed consent
Key exclusion criteria (6 listed)
- Contraindication for study drugs
- Pre-existing antibiotic therapy within 14 days of surgery
- Any doubt that patients can make the decision to participate fully informed due to cognitive impairment, such as in critically ill or demented patients.
- Emergency procedures with planned incision within 2 hours after the surgeon indicated the procedure
- Participation in other studies that could potentially interfere with the present one (according to the ethics committee)
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 |
|---|---|---|
| Early administration of SAP (Cefuroxime (plus metronidazole in colorectal surgery)) in anesthetic room (75 to 30 minutes prior to skin incision) | Procedure or surgery | Early Prophylaxis |
| Late administration of SAP (Cefuroxime (plus metronidazole in colorectal surgery)) in the operating theatre (within 30 minutes prior to skin incision) | Procedure or surgery | Late Prophylaxis |
Primary outcome
Surgical Site Infection (SSI)
Time frame: 30 days
Surgical Site Infection within 30 days after index surgery
6 secondary outcomes
All-cause 30 day mortality
Time frame: 30 days
Length of hospital stay
Time frame: 1 year
Economic burden of SSI
Time frame: 1 year
Nosocomial infections
Time frame: 1 year
In-hospital complications
Time frame: 1 year
Surgical Site Infection (SSI)
Time frame: 1 year
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 29 Sep 2016.
- Derived from this study: PubMed 40260835Cristino MA, Nakano LC, Vasconcelos V, Correia RM, Flumignan RL. Prevention of infection in aortic or aortoiliac peripheral arterial reconstruction. Cochrane Database Syst Rev. 2025 Apr 22;4(4):CD015192. doi: 10.1002/14651858.CD015192.pub2.
- Derived from this study: PubMed 34750659Kopp Lugli A, Marti WR, Salm L, Mujagic E, Bundi M, von Strauss M, Bucheli Laffer E, Landin J, Fux CA, Coslovsky M, Weber WP, Kindler C. The Role of HbA1c as a Positive Perioperative Predictor of Surgical Site and Other Postoperative Infections: An Explorative Analysis in Patients Undergoing Minor to Major Surgery. World J Surg. 2022 Feb;46(2):391-399. doi: 10.1007/s00268-021-06368-x. Epub 2021 Nov 8.
- Derived from this study: PubMed 28385346Weber WP, Mujagic E, Zwahlen M, Bundi M, Hoffmann H, Soysal SD, Kraljevic M, Delko T, von Strauss M, Iselin L, Da Silva RXS, Zeindler J, Rosenthal R, Misteli H, Kindler C, Muller P, Saccilotto R, Lugli AK, Kaufmann M, Gurke L, von Holzen U, Oertli D, Bucheli-Laffer E, Landin J, Widmer AF, Fux CA, Marti WR. Timing of surgical antimicrobial prophylaxis: a phase 3 randomised controlled trial. Lancet Infect Dis. 2017 Jun;17(6):605-614. doi: 10.1016/S1473-3099(17)30176-7. Epub 2017 Apr 3.
- Derived from this study: PubMed 24885132Mujagic E, Zwimpfer T, Marti WR, Zwahlen M, Hoffmann H, Kindler C, Fux C, Misteli H, Iselin L, Lugli AK, Nebiker CA, von Holzen U, Vinzens F, von Strauss M, Reck S, Kraljevic M, Widmer AF, Oertli D, Rosenthal R, Weber WP. Evaluating the optimal timing of surgical antimicrobial prophylaxis: study protocol for a randomized controlled trial. Trials. 2014 May 24;15:188. doi: 10.1186/1745-6215-15-188.
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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.
Walter P. Weber, MD principal investigator
University Hospital Basel, Basel 4031 Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Early administration of SAP (Cefuroxime (plus metronidazole in colorectal surgery)) in anesthetic room (75 to 30 minutes prior to skin incision) and Late administration of SAP (Cefuroxime (plus metronidazole in colorectal surgery)) in the operating theatre (within 30 minutes prior to skin incision) in people with Surgical Site Infection, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 4 inclusion and 6 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 29 Sep 2016. 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 Switzerland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Surgical Site Infection (SSI) (time frame: 30 days). 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 NCT01790529, which also lists 4 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 29 Sep 2016.