StrabismusPhase 4PASSNCT00461656
Povidone-iodine Antisepsis for Strabismus Surgery
A Phase 4 study testing Preoperative conjunctival irrigation with 5% or 1.25% PI in people with Strabismus and Surgery, run by Erasmus Medical Center at 9 sites in 2 countries.
Trial summary
The purpose of this study is to compare the efficacy of 5 % vs. 1.25 % povidone-iodine (PI) as preoperative antiseptic prior to strabismus surgery in children as a prophylaxis of endophthalmitis. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Strabismus, Surgery, Endophthalmitis
- What is being tested?
- Preoperative conjunctival irrigation with 5% or 1.25% PI
- How many people
- 70 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Sep 2009to Dec 2012
- 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 Up to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children attending for routine strabismus surgery are eligible for the study. Criteria for inclusion:
- Children < 6 years of age
- undergoing surgery for strabismus for the first time, including any recession and/or resection surgery of the medial and/or lateral rectus muscles.
- willing to take part in all aspects of the study with written informed consent on the study participation of the child provided by the parents.
Who cannot join
- Any history or current condition of hypersensitivity to iodine
- Children on topical antibiotic within the last 30 days
- Children with signs of acute conjunctivitis, blepharitis, dacryocystitis or respiratory infection within the last 30 days
- Children with asthma or similar chronic, obstructive pulmonary disorder
- Insufficiently treated amblyopia, i.e. a difference between the visual acuities of both eyes larger than 1 LogMARline.
- Neurological or psychiatric disorder, medication, other eye disorder, decreased visual acuity caused by brain damage or trauma.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Netherlands6 sites
Dept. Ophthalmology Free University Medical Center
Amsterdam, NL-1007MB
Dept. Ophthalmology Academical Medical Center
Amsterdam, NL-1105AZ
Dept. Ophthalmology
Leiden, NL-2300RC
Dept. of Ophthalmology St. Laurentius Ziekenhuis
Roermond, NL-6040AX
Rotterdam Eye Hospital
Rotterdam, 3011BH
Dept. of Ophthalmology Erasmus Medical Center
Rotterdam, NL3000CA
Germany3 sites
Ernst Moritz Arndt University
Greifswald, D-17487
Universitäts-Augenklinik
Magdeburg, D-39120
Universitäts-Augenklinik Ludwig-Maximilian University
Munich, D-80336
About this study
Official title: Prospective, Randomized, Double-blind Comparison of 5 % Against 1.25 % Povidone-iodine Solution as Preoperative Antisepsis for Strabismus Surgery in Young Children
The purpose of this study is to compare the efficacy of 5 % vs. 1.25 % povidone-iodine (PI) as preoperative antiseptic prior to strabismus surgery in children as a prophylaxis of endophthalmitis. Given the low rate of endophthalmitis the conjunctival bacterial flora rate is used as surrogate marker to determine the effectiveness of topical PI in reducing or eliminating bacteria from the ocular surface at the time of the surgery. Secondary objective is a reduction of the incidence of postoperative endophthalmitis after strabismus surgery in young children.
Read the detailed description
Background: Endophthalmitis after strabismus surgery in young children leads to blindness and loss of the affected eye. It is caused by conjunctival bacteria. PI solutions between 1% and 5% reduce the number of bacteria on the conjunctiva. The concentration used varies widely among clinics, from 1% to 5%. In vitro studies have shown that PI is paradoxically more effective at lower concentration, but in cataract surgery in elderly, 1% PI has been shown to be less effective than 5% PI. Dilution by tear fluid or binding of PI to proteins in tear fluid may lower its effectiveness. Since endophthalmitis after strabismus surgery especially affects young children and the bacterial flora of the conjunctiva in children is different from that in adults, the cataract PI study should be repeated in young children operated for strabismus.
Objective: To compare the efficacy of 5 % vs. 1.25 % povidone-iodine (PI) as preoperative antiseptic prior to strabismus surgery in children as a prophylaxis of endophthalmitis. Given the low rate of endophthalmitis the conjunctival bacterial flora rate is used as surrogate marker to determine the effectiveness of topical PI in reducing or eliminating bacteria from the ocular surface at the time of the surgery.
Design: The study is a multi-centre, prospective, randomized-controlled, parallel-groups, assessor-blind (microbiological assessments), investigator-initiated trial.
Study population: All children under 6 years of age attending the 15 participating clinics for routine strabismus surgery will be eligible for the study at the point that a strabismus operation is planned. The clinics (5 Dutch, 10 German) will each recruit approximately 20 patients. The minimum sample size is 2 x 100 patients.
Intervention: Diluted PI, 1.25% or 5%, will be prepared in a sterile fashion, and distributed in single-use dispensers. These will be coded for randomization. Before initiation of surgery, children randomized to the 5% PI group will have their conjunctival fornices irrigated with 5 ml PI 5%. Children randomized to the 1.25% PI group will have their conjunctival fornices irrigated with 5 ml PI 1.25%. Conjunctiva cultures for aerobic and anaerobic bacteria will be obtained (1) after general anesthesia has been established, (2) 5-10 min after PI irrigation, (3) after reattachment of the eye muscles and (4) after closing the conjunctiva with sutures.
Primary outcome: The difference in the mean numbers of bacterial colony forming units (CFUs) from pre-irrigation (l) to post-irrigation with PI (2-4).
Secondary outcome: Iodine excretion after surgery, assessed as urine iodine concentration per creatinine clearance.
Postoperative erosion of the cornea and corneal oedema. Both of these have been described as side-effects of PI use.
Nature and extent of the burden and risks associated with participation:
Risks are limited to the act of taking the four bacterial cultures, as both 1.25% PI and 5% PI are approved preoperative antiseptic applications of PI and both are used, rather indiscriminately, by the university departments of ophthalmology participating in the study.
- Conditions
- Strabismus, Surgery, Endophthalmitis
- Being tested
- Preoperative conjunctival irrigation with 5% or 1.25% PI
- Keywords
- Antiseptic, Povidone-Iodine
- Medical subject headings
- Strabismus, Endophthalmitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative conjunctival irrigation with 5% or 1.25% PIDrug
Before initiation of surgery, children will have their conjunctival fornices irrigated with 5 ml PI 5% or with 5 ml PI 1.25%
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in the mean numbers of bacterial colony forming units from pre-irrigation to post-irrigation with PI.
Measured: Cultures taken during surgery, evaluated within 2 days postoperatively
Secondary outcomes (2)
Iodine excretion after surgery, assessed as urine iodine concentration per creatinine clearance.
Measured: 24 hours postoperatively
Postoperative erosion of the cornea and corneal oedema.
Measured: within 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2007 (estimated)
- Study startSep 2009
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for StrabismusStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich, University Medicine Greifswald, Universitair Ziekenhuis Brussel, Leiden University Medical Center, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Rotterdam Eye Hospital, Laurentius Hospital Roermond, Martin-Luther-Universität Halle-Wittenberg
- Investigators
- Huibert J Simonsz, MD PhD, Principal investigator, Erasmus Medical CenterHerminia Miño de Kaspar, PhD, Principal investigator, Universitäts-Augenklinik Ludwig-Maximilian University Munich Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00461656
- Sponsor's protocol ID
- ABR 14357
- Acronym
- PASS
- Status last verified
- Jul 2011
- First submitted
- 17 Apr 2007
- Last updated
- 5 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Anderson RL, Vess RW, Carr JH, Bond WW, Panlilio AL, Favero MS. Investigations of intrinsic Pseudomonas cepacia contamination in commercially manufactured povidone-iodine. Infect Control Hosp Epidemiol. 1991 May;12(5):297-302. doi: 10.1086/646342.
PubMed 1865100Apt L, Isenberg S, Yoshimori R, Paez JH. Chemical preparation of the eye in ophthalmic surgery. III. Effect of povidone-iodine on the conjunctiva. Arch Ophthalmol. 1984 May;102(5):728-9. doi: 10.1001/archopht.1984.01040030584025.
PubMed 6721765Bannerman TL, Rhoden DL, McAllister SK, Miller JM, Wilson LA. The source of coagulase-negative staphylococci in the Endophthalmitis Vitrectomy Study. A comparison of eyelid and intraocular isolates using pulsed-field gel electrophoresis. Arch Ophthalmol. 1997 Mar;115(3):357-61. doi: 10.1001/archopht.1997.01100150359008.
PubMed 9076208Berkelman RL, Holland BW, Anderson RL. Increased bactericidal activity of dilute preparations of povidone-iodine solutions. J Clin Microbiol. 1982 Apr;15(4):635-9. doi: 10.1128/jcm.15.4.635-639.1982.
PubMed 7040461Binder CA, Mino de Kaspar H, Klauss V, Kampik A. [Preoperative infection prophylaxis with 1% polyvidon-iodine solution based on the example of conjunctival staphylococci]. Ophthalmologe. 1999 Oct;96(10):663-7. doi: 10.1007/s003470050471. German.
PubMed 10552160Caldwell DR, Kastl PR, Cook J, Simon J. Povidone-iodine: its efficacy as a preoperative conjunctival and periocular preparation. Ann Ophthalmol. 1984 Jun;16(6):577, 580.
PubMed 6611102Carothers TS, Coats DK, McCreery KM, Rossman SN, Wilson P, Wu TG, Paysse EA. Quantification of incidental needle and suture contamination during strabismus surgery. Binocul Vis Strabismus Q. 2003;18(2):75-9.
PubMed 12765540Ciulla TA, Starr MB, Masket S. Bacterial endophthalmitis prophylaxis for cataract surgery: an evidence-based update. Ophthalmology. 2002 Jan;109(1):13-24. doi: 10.1016/s0161-6420(01)00899-5.
PubMed 11772573Davis GH, Finlayson N, Kemp R. Dilution of povidone-iodine. Med J Aust. 1985 Sep 30;143(7):321. doi: 10.5694/j.1326-5377.1985.tb123038.x. No abstract available.
PubMed 4046931Dereklis DL, Bufidis TA, Tsiakiri EP, Palassopoulos SI. Preoperative ocular disinfection by the use of povidone-iodine 5%. Acta Ophthalmol (Copenh). 1994 Oct;72(5):627-30. doi: 10.1111/j.1755-3768.1994.tb07191.x.
PubMed 7887164Ferguson AW, Scott JA, McGavigan J, Elton RA, McLean J, Schmidt U, Kelkar R, Dhillon B. Comparison of 5% povidone-iodine solution against 1% povidone-iodine solution in preoperative cataract surgery antisepsis: a prospective randomised double blind study. Br J Ophthalmol. 2003 Feb;87(2):163-7. doi: 10.1136/bjo.87.2.163.
PubMed 12543744Grimes SR, Hollsten D, Nauschuetz WF, Whiddon RG, Trevino SB. Effect of povidone-iodine irrigation on the preoperative chemical preparation of the eye. Mil Med. 1992 Mar;157(3):111-3.
PubMed 1603399Katosova LK. [The features of Haemophilus influenza and Streptococcus pneumoniae carriage and the comparative characteristics of strains isolated from healthy children and from patients with acute and chronic respiratory infections]. Zh Mikrobiol Epidemiol Immunobiol. 1994 Aug-Sep;Suppl 1:55-60. Russian.
PubMed 7856352Khashu M, Chessex P, Chanoine JP. Iodine overload and severe hypothyroidism in a premature neonate. J Pediatr Surg. 2005 Feb;40(2):E1-4. doi: 10.1016/j.jpedsurg.2004.10.028.
PubMed 15750908Lacey RW, Catto A. Action of povidone-iodine against methicillin-sensitive and -resistant cultures of Staphylococcus aureus. Postgrad Med J. 1993;69 Suppl 3(818):S78-83.
PubMed 8290463
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Double-blind Comparison of 5 % Against 1.25 % Povidone-iodine Solution as Preoperative Antisepsis for Strabismus Surgery in Young Children
- ClinicalTrials.gov ID
- NCT00461656
- Acronym / sponsor ID
- PASS / ABR 14357
- Conditions
- Strabismus, Surgery, Endophthalmitis
- Keywords
- Antiseptic, Povidone-Iodine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich, University Medicine Greifswald, Universitair Ziekenhuis Brussel, Leiden University Medical Center, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Rotterdam Eye Hospital, Laurentius Hospital Roermond, Martin-Luther-Universität Halle-Wittenberg
- Study start
- Sep 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 18 Apr 2007 (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.
The purpose of this study is to compare the efficacy of 5 % vs. 1.25 % povidone-iodine (PI) as preoperative antiseptic prior to strabismus surgery in children as a prophylaxis of endophthalmitis. Given the low rate of endophthalmitis the conjunctival bacterial flora rate is used as surrogate marker to determine the effectiveness of topical PI in reducing or eliminating bacteria from the ocular surface at the time of the surgery. Secondary objective is a reduction of the incidence of postoperative endophthalmitis after strabismus surgery in young children.
Detailed description
Background: Endophthalmitis after strabismus surgery in young children leads to blindness and loss of the affected eye. It is caused by conjunctival bacteria. PI solutions between 1% and 5% reduce the number of bacteria on the conjunctiva. The concentration used varies widely among clinics, from 1% to 5%. In vitro studies have shown that PI is paradoxically more effective at lower concentration, but in cataract surgery in elderly, 1% PI has been shown to be less effective than 5% PI. Dilution by tear fluid or binding of PI to proteins in tear fluid may lower its effectiveness. Since endophthalmitis after strabismus surgery especially affects young children and the bacterial flora of the conjunctiva in children is different from that in adults, the cataract PI study should be repeated in young children operated for strabismus.
Objective: To compare the efficacy of 5 % vs. 1.25 % povidone-iodine (PI) as preoperative antiseptic prior to strabismus surgery in children as a prophylaxis of endophthalmitis. Given the low rate of endophthalmitis the conjunctival bacterial flora rate is used as surrogate marker to determine the effectiveness of topical PI in reducing or eliminating bacteria from the ocular surface at the time of the surgery.
Design: The study is a multi-centre, prospective, randomized-controlled, parallel-groups, assessor-blind (microbiological assessments), investigator-initiated trial.
Study population: All children under 6 years of age attending the 15 participating clinics for routine strabismus surgery will be eligible for the study at the point that a strabismus operation is planned. The clinics (5 Dutch, 10 German) will each recruit approximately 20 patients. The minimum sample size is 2 x 100 patients.
Intervention: Diluted PI, 1.25% or 5%, will be prepared in a sterile fashion, and distributed in single-use dispensers. These will be coded for randomization. Before initiation of surgery, children randomized to the 5% PI group will have their conjunctival fornices irrigated with 5 ml PI 5%. Children randomized to the 1.25% PI group will have their conjunctival fornices irrigated with 5 ml PI 1.25%. Conjunctiva cultures for aerobic and anaerobic bacteria will be obtained (1) after general anesthesia has been established, (2) 5-10 min after PI irrigation, (3) after reattachment of the eye muscles and (4) after closing the conjunctiva with sutures.
Primary outcome: The difference in the mean numbers of bacterial colony forming units (CFUs) from pre-irrigation (l) to post-irrigation with PI (2-4).
Secondary outcome: Iodine excretion after surgery, assessed as urine iodine concentration per creatinine clearance.
Postoperative erosion of the cornea and corneal oedema. Both of these have been described as side-effects of PI use.
Nature and extent of the burden and risks associated with participation:
Risks are limited to the act of taking the four bacterial cultures, as both 1.25% PI and 5% PI are approved preoperative antiseptic applications of PI and both are used, rather indiscriminately, by the university departments of ophthalmology participating in the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children attending for routine strabismus surgery are eligible for the study. Criteria for inclusion:
- Children < 6 years of age
- undergoing surgery for strabismus for the first time, including any recession and/or resection surgery of the medial and/or lateral rectus muscles.
- willing to take part in all aspects of the study with written informed consent on the study participation of the child provided by the parents.
Key exclusion criteria (6 listed)
- Any history or current condition of hypersensitivity to iodine
- Children on topical antibiotic within the last 30 days
- Children with signs of acute conjunctivitis, blepharitis, dacryocystitis or respiratory infection within the last 30 days
- Children with asthma or similar chronic, obstructive pulmonary disorder
- Insufficiently treated amblyopia, i.e. a difference between the visual acuities of both eyes larger than 1 LogMARline.
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 |
|---|---|---|
| Preoperative conjunctival irrigation with 5% or 1.25% PIBefore initiation of surgery, children will have their conjunctival fornices irrigated with 5 ml PI 5% or with 5 ml PI 1.25% | Drug | – |
Primary outcome
The difference in the mean numbers of bacterial colony forming units from pre-irrigation to post-irrigation with PI.
Time frame: Cultures taken during surgery, evaluated within 2 days postoperatively
2 secondary outcomes
Iodine excretion after surgery, assessed as urine iodine concentration per creatinine clearance.
Time frame: 24 hours postoperatively
Postoperative erosion of the cornea and corneal oedema.
Time frame: within 24 hours postoperatively
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 5 Mar 2013.
- Background: PubMed 1865100Anderson RL, Vess RW, Carr JH, Bond WW, Panlilio AL, Favero MS. Investigations of intrinsic Pseudomonas cepacia contamination in commercially manufactured povidone-iodine. Infect Control Hosp Epidemiol. 1991 May;12(5):297-302. doi: 10.1086/646342.
- Background: PubMed 6721765Apt L, Isenberg S, Yoshimori R, Paez JH. Chemical preparation of the eye in ophthalmic surgery. III. Effect of povidone-iodine on the conjunctiva. Arch Ophthalmol. 1984 May;102(5):728-9. doi: 10.1001/archopht.1984.01040030584025.
- Background: PubMed 9076208Bannerman TL, Rhoden DL, McAllister SK, Miller JM, Wilson LA. The source of coagulase-negative staphylococci in the Endophthalmitis Vitrectomy Study. A comparison of eyelid and intraocular isolates using pulsed-field gel electrophoresis. Arch Ophthalmol. 1997 Mar;115(3):357-61. doi: 10.1001/archopht.1997.01100150359008.
- Background: PubMed 7040461Berkelman RL, Holland BW, Anderson RL. Increased bactericidal activity of dilute preparations of povidone-iodine solutions. J Clin Microbiol. 1982 Apr;15(4):635-9. doi: 10.1128/jcm.15.4.635-639.1982.
- Background: PubMed 10552160Binder CA, Mino de Kaspar H, Klauss V, Kampik A. [Preoperative infection prophylaxis with 1% polyvidon-iodine solution based on the example of conjunctival staphylococci]. Ophthalmologe. 1999 Oct;96(10):663-7. doi: 10.1007/s003470050471. German.
- Background: PubMed 6611102Caldwell DR, Kastl PR, Cook J, Simon J. Povidone-iodine: its efficacy as a preoperative conjunctival and periocular preparation. Ann Ophthalmol. 1984 Jun;16(6):577, 580.
- Background: PubMed 12765540Carothers TS, Coats DK, McCreery KM, Rossman SN, Wilson P, Wu TG, Paysse EA. Quantification of incidental needle and suture contamination during strabismus surgery. Binocul Vis Strabismus Q. 2003;18(2):75-9.
- Background: PubMed 11772573Ciulla TA, Starr MB, Masket S. Bacterial endophthalmitis prophylaxis for cataract surgery: an evidence-based update. Ophthalmology. 2002 Jan;109(1):13-24. doi: 10.1016/s0161-6420(01)00899-5.
- Background: PubMed 4046931Davis GH, Finlayson N, Kemp R. Dilution of povidone-iodine. Med J Aust. 1985 Sep 30;143(7):321. doi: 10.5694/j.1326-5377.1985.tb123038.x. No abstract available.
- Background: PubMed 7887164Dereklis DL, Bufidis TA, Tsiakiri EP, Palassopoulos SI. Preoperative ocular disinfection by the use of povidone-iodine 5%. Acta Ophthalmol (Copenh). 1994 Oct;72(5):627-30. doi: 10.1111/j.1755-3768.1994.tb07191.x.
- Background: PubMed 12543744Ferguson AW, Scott JA, McGavigan J, Elton RA, McLean J, Schmidt U, Kelkar R, Dhillon B. Comparison of 5% povidone-iodine solution against 1% povidone-iodine solution in preoperative cataract surgery antisepsis: a prospective randomised double blind study. Br J Ophthalmol. 2003 Feb;87(2):163-7. doi: 10.1136/bjo.87.2.163.
- Background: PubMed 1603399Grimes SR, Hollsten D, Nauschuetz WF, Whiddon RG, Trevino SB. Effect of povidone-iodine irrigation on the preoperative chemical preparation of the eye. Mil Med. 1992 Mar;157(3):111-3.
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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.
Huibert J Simonsz, MD PhD principal investigator
Erasmus Medical Center
Herminia Miño de Kaspar, PhD principal investigator
Universitäts-Augenklinik Ludwig-Maximilian University Munich Germany
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Preoperative conjunctival irrigation with 5% or 1.25% PI in people with Strabismus and Surgery, run by Erasmus Medical Center at 9 sites in 2 countries.
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 5 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Netherlands, Germany. 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?
The difference in the mean numbers of bacterial colony forming units from pre-irrigation to post-irrigation with PI. (time frame: Cultures taken during surgery, evaluated within 2 days postoperatively). 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 NCT00461656, which also lists 25 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 5 Mar 2013.