EndophthalmitisNCT03812640
Nylon Verus Polyglactin Corneal Suture in Pediatric Cataract Surgery
A study testing Vicryl suture and Nylon suture in people with Endophthalmitis and Cataracts Infantile, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
Pediatric cataract surgery requires the suturing of the corneal incision in order to maintain the integrity of the eyeball and to help avoid the trauma often caused by scratching in the postoperative period of pediatric surgeries. Traditionally, this suturing is performed using 10-0 nylon material. Read more about this study
- Who is it for?
- Ages 30 days to 14 years
- Conditions the study is for
- Endophthalmitis, Cataracts Infantile, Suture, Complication
- What is being tested?
- Vicryl suture and Nylon suture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2019to 1 Oct 2019
- 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 30 days to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients up to 14 years of age who are clinically qualified to undergo pediatric cataract surgery
Who cannot join
- Traumatic cataract with ocular perforation
- Cataract surgery associated with other procedures, such as glaucoma filtering surgery, vitreoretinal surgery, and cornea surgery
- Signs of ocular or periocular infection
- Advanced glaucoma
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Mathias Violante Mélega
Campinas, São Paulo, 13025-050
Mathias V Mélega, 19997513150, mvmelega@hotmail.com
About this study
Official title: Comparison Between Nylon and Polyglactin Corneal Suture in Pediatric Cataract Surgery: a Randomized Controlled Clinical Trial
Pediatric cataract surgery requires the suturing of the corneal incision in order to maintain the integrity of the eyeball and to help avoid the trauma often caused by scratching in the postoperative period of pediatric surgeries. Traditionally, this suturing is performed using 10-0 nylon material. Because this material is non-absorbable, it must be removed under sedation in cases of complications such as suture loosening, late suture lysis, accumulation of secretion on the suture, corneal neovascularization, and corneal ulceration. The objetive of this study is to compare the rate of postoperative complications and the need for suture removal after pediatric cataract surgery in cases in which nylon (non-absorbable) sutures are used versus cases in which polyglactin (absorbable) sutures are used.
This is a controlled, randomized, prospective, single-center study performed on patients undergoing pediatric cataract surgery at the Clinical Hospital of the University of Campinas (UNICAMP). The volunteers for whom cataract extraction surgery has been indicated and who have signed the ICF (or whose ICF has been signed by a parent or guardian) will undergo cataract surgery and the cornea will be sutured using a polyglactin 910 suture (Vicryl® 10-0). In the control group (Group B), the cornea will be sutured using nylon 10-0 sutures (the current routine procedure). All patients will be monitored for six months and will receive complete ophthalmological evaluations in order to determine whether they experience any suture-related complications and whether sutures must be removed under sedation. A lower incidence of complications and a less frequent need for suture removal under sedation are expected in the group receiving Vicryl® sutures.
Read the detailed description
Patients who are diagnosed with cataracts and for whom surgery is indicated shall be evaluated (as much as possible based on their ability to cooperate with the assessment) in terms of their visual acuity and refractive error via biomicroscopy, automated keratometry (Auto Kerato Refractometer KR 8000® Alcon), Goldmann applanation tonometry, fundoscopy, and biometric assessment (Ocuscan RxP® Alcon or Lenstar LS900® Haag-Streit International).
Patients who choose to sign (or whose guardians choose to sign) the informed consent form after being informed of all of the aspects of the surgery and this trial shall be randomly divided into one of two groups that shall be approximately equal in size and stratified by age.
- Up to 6 months of age
- From 6 to 12 months of age
- From 1 to 3 years of age
- From 3 to 6 years of age
- Older than 6 years Patients in Group A will have their surgical incisions sutured with polyglactin 10-0 material (Vicryl®, composed of polyglactin 910, 10-0 diameter, absorbable, a 0.62 cm, 3/8 circle needle) at the end of cataract surgery followed by the use of 0.5% moxifloxacin and 0.1% dexamethasone eye drops before the bandage is applied. Patients in Group B will have their surgical incisions sutured with nylon 10-0 material (Vicryl®, composed of nylon monofilament, 10-0 diameter, absorbable, a 0.55 cm, 1/2 circle needle) at the end of cataract surgery followed by the use of 0.5% moxifloxacin and 0.1% dexamethasone eye drops before the bandage is applied.
Cataract surgery will be performed using the standardized protocol in the Ophthalmology department of UNICAMP by fourth-year ophthalmology residents with experience in pediatric cataract surgery. Preoperative pupil dilation shall be performed through the use of 2.5% phenylephrine and 1% tropicamide 3 times in five-minute increments. General anesthesia shall be performed. Skin sterilization shall be performed using an aqueous solution of 10% povidone-iodine. After the sterile surgical field is established and the eyelashes are isolated, 4 eye drops containing 5% povidone-iodine shall be administered in the conjunctival sac with subsequent irrigation using a 10% balanced salt solution. In cases of allergy to povidone-iodine, an aqueous solution of 0.05% chlorhexidine shall be used. The main incision (either a clear corneal incision or a scleral tunnel) will be 2.2 mm to 3.0 mm, and aspiration will be applied using the Infiniti® or Laureate® phacoemulsifier (Alcon) with a foldable AcrySof® intraocular lens (Alcon) and a posterior capsulotomy with an automated vitrectomy only in cases in which it is indicated.
Neither patients nor surgeons will be masked to the study treatment. The postoperative consultations will be held on the first, seventh, thirtieth, ninetieth, one hundred and twentieth, and one hundred and eightieth postoperative days and will include visual acuity assessments, refractive error assessments, keratometry , biomicroscopy, applanation tonometry, and fundoscopy, depending on the patient's age and ability to cooperate. If a necessary exam is not possible in a clinical setting, it will be performed under sedation in the surgical center.
Primary outcome: frequency of complications associated with sutures in each group.
Secondary outcome: need for suture removal under sedation in each group. The following will be defined as suture-related complications: corneal neovascularization close to the suture, loosening of the suture, accumulation of mucus on the suture, early rupture (within 2 weeks or less) of the suture, aqueous humor leakage through the incision (as determined by the Seidel test), prolapse of the iris through the incision site, infectious or traumatic keratitis, endophthalmitis and giant papillary conjunctivitis as observed in a biomicroscopy exam using a slit lamp.
Based on the frequency of suture-related complications described in the literature and using a two-tailed 95% confidence interval, 80% power, an exposed/unexposed radius of 1, and a null frequency of complications in the polyglactin suture group, approximately 40 subjects are needed for each group. UNICAMP performs an average of 75 pediatric cataract surgeries per year. Thus, there is a perspective for patient inclusion and study completion of just over one year.
- Conditions
- Endophthalmitis, Cataracts Infantile, Suture, Complication
- Being tested
- Vicryl suture, Nylon suture
- Keywords
- pediatric, cataract, suture, poliglactin, nylon
- Medical subject headings
- Endophthalmitis, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vicryl sutureDevice
Corneal suture with Vicryl suture
Nylon sutureDevice
Corneal suture with Nylon suture
| Study group | Role | What they receive |
|---|---|---|
| Vicryl | Experimental | Vicryl suture Receives: Device: Vicryl suture |
| Nylon | Active comparator | Nylon suture Receives: Device: Nylon suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of complications associated with sutures in each group
frequency of complications associated with sutures in each group
Measured: 180 days
Secondary outcomes (1)
need for suture removal under sedation in each group.
need for suture removal under sedation in each group.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start1 Jan 2019
- Primary completion1 Sep 2019 (estimated)
- Study completion1 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for EndophthalmitisStudies 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mathias Violante Mélega, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03812640
- Sponsor's protocol ID
- Vicryl Unicamp
- Status last verified
- Jan 2019
- First submitted
- 18 Jan 2019
- Last updated
- 25 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Foster A, Gilbert C, Rahi J. Epidemiology of cataract in childhood: a global perspective. J Cataract Refract Surg. 1997;23 Suppl 1:601-4. doi: 10.1016/s0886-3350(97)80040-5.
PubMed 9278811Gilbert CE, Wood M, Waddel K, Foster A. Causes of childhood blindness in east Africa: results in 491 pupils attending 17 schools for the blind in Malawi, Kenya and Uganda. Ophthalmic Epidemiol. 1995 Jun;2(2):77-84. doi: 10.3109/09286589509057086.
PubMed 7585238Haargaard B, Wohlfahrt J, Fledelius HC, Rosenberg T, Melbye M. Incidence and cumulative risk of childhood cataract in a cohort of 2.6 million Danish children. Invest Ophthalmol Vis Sci. 2004 May;45(5):1316-20. doi: 10.1167/iovs.03-0635.
PubMed 15111583WHO | Priority eye diseases. WHO [Internet]. 2014 [cited 2017 Dec 29]; Available from: http://www.who.int/blindness/causes/priority/en/index3.html
Wilson BME. Pediatric Cataracts : Overview Classification ( Categorization ). 2016;
Heaven CJ, Boase DL. Suppurative keratitis with endophthalmitis due to biodegraded full thickness monofilament nylon corneal sutures. Eur J Implant Refract Surg [Internet]. 1993;5(3):164-8. Available from: http://dx.doi.org/10.1016/S0955-3681(13)80436-4
Lee BJ, Smith SD, Jeng BH. Suture-related corneal infections after clear corneal cataract surgery. J Cataract Refract Surg. 2009 May;35(5):939-42. doi: 10.1016/j.jcrs.2008.10.061.
PubMed 19393897Culbert RB, Devenyi RG. Bacterial endophthalmitis after suture removal. J Cataract Refract Surg. 1999 May;25(5):725-7. doi: 10.1016/s0886-3350(99)00020-6.
PubMed 10330655Khurshid GS, Fahy GT. Endophthalmitis secondary to corneal sutures: series of delayed-onset keratitis requiring intravitreal antibiotics. J Cataract Refract Surg. 2003 Jul;29(7):1370-2. doi: 10.1016/s0886-3350(03)00404-8.
PubMed 12900247Acheson JF, Lyons CJ. Ocular morbidity due to monofilament nylon corneal sutures. Eye (Lond). 1991;5 ( Pt 1):106-12. doi: 10.1038/eye.1991.20. No abstract available.
PubMed 2060657Danjoux JP, Reck AC, to C. CORNEAL SUTURES: IS ROUTINE REMOVAL REALLY NECESSARY? [cited 2017 Dec 28]; Available from: https://www.nature.com/articles/eye199470.pdf
Bainbridge JW, Teimory M, Kirwan JF, Rostron CK. A prospective controlled study of a 10/0 absorbable polyglactin suture for corneal incision phacoemulsification. Eye (Lond). 1998;12 ( Pt 3a):399-402. doi: 10.1038/eye.1998.94.
PubMed 9775239Bar-Sela SM, Spierer O, Spierer A. Suture-related complications after congenital cataract surgery: Vicryl versus Mersilene sutures. J Cataract Refract Surg. 2007 Feb;33(2):301-4. doi: 10.1016/j.jcrs.2006.10.039.
PubMed 17276274Melega MV, Dos Reis R, Lira RPC, de Oliveira DF, Arieta CEL, Alves M. Comparison Between Nylon and Polyglactin Sutures in Pediatric Cataract Surgery: A Randomized Controlled Clinical Trial. Front Med (Lausanne). 2021 Aug 27;8:700793. doi: 10.3389/fmed.2021.700793. eCollection 2021.
PubMed 34513873
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Nylon and Polyglactin Corneal Suture in Pediatric Cataract Surgery: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03812640
- Acronym / sponsor ID
- Vicryl Unicamp
- Conditions
- Endophthalmitis, Cataracts Infantile, Suture, Complication
- Keywords
- pediatric, cataract, suture, poliglactin, nylon
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Sep 2019 (estimated)
- Study completion
- 1 Oct 2019 (estimated)
- First posted
- 23 Jan 2019 (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.
Pediatric cataract surgery requires the suturing of the corneal incision in order to maintain the integrity of the eyeball and to help avoid the trauma often caused by scratching in the postoperative period of pediatric surgeries. Traditionally, this suturing is performed using 10-0 nylon material. Because this material is non-absorbable, it must be removed under sedation in cases of complications such as suture loosening, late suture lysis, accumulation of secretion on the suture, corneal neovascularization, and corneal ulceration. The objetive of this study is to compare the rate of postoperative complications and the need for suture removal after pediatric cataract surgery in cases in which nylon (non-absorbable) sutures are used versus cases in which polyglactin (absorbable) sutures are used.
This is a controlled, randomized, prospective, single-center study performed on patients undergoing pediatric cataract surgery at the Clinical Hospital of the University of Campinas (UNICAMP). The volunteers for whom cataract extraction surgery has been indicated and who have signed the ICF (or whose ICF has been signed by a parent or guardian) will undergo cataract surgery and the cornea will be sutured using a polyglactin 910 suture (Vicryl® 10-0). In the control group (Group B), the cornea will be sutured using nylon 10-0 sutures (the current routine procedure). All patients will be monitored for six months and will receive complete ophthalmological evaluations in order to determine whether they experience any suture-related complications and whether sutures must be removed under sedation. A lower incidence of complications and a less frequent need for suture removal under sedation are expected in the group receiving Vicryl® sutures.
Detailed description
Patients who are diagnosed with cataracts and for whom surgery is indicated shall be evaluated (as much as possible based on their ability to cooperate with the assessment) in terms of their visual acuity and refractive error via biomicroscopy, automated keratometry (Auto Kerato Refractometer KR 8000® Alcon), Goldmann applanation tonometry, fundoscopy, and biometric assessment (Ocuscan RxP® Alcon or Lenstar LS900® Haag-Streit International).
Patients who choose to sign (or whose guardians choose to sign) the informed consent form after being informed of all of the aspects of the surgery and this trial shall be randomly divided into one of two groups that shall be approximately equal in size and stratified by age.
- Up to 6 months of age
- From 6 to 12 months of age
- From 1 to 3 years of age
- From 3 to 6 years of age
- Older than 6 years Patients in Group A will have their surgical incisions sutured with polyglactin 10-0 material (Vicryl®, composed of polyglactin 910, 10-0 diameter, absorbable, a 0.62 cm, 3/8 circle needle) at the end of cataract surgery followed by the use of 0.5% moxifloxacin and 0.1% dexamethasone eye drops before the bandage is applied. Patients in Group B will have their surgical incisions sutured with nylon 10-0 material (Vicryl®, composed of nylon monofilament, 10-0 diameter, absorbable, a 0.55 cm, 1/2 circle needle) at the end of cataract surgery followed by the use of 0.5% moxifloxacin and 0.1% dexamethasone eye drops before the bandage is applied.
Cataract surgery will be performed using the standardized protocol in the Ophthalmology department of UNICAMP by fourth-year ophthalmology residents with experience in pediatric cataract surgery. Preoperative pupil dilation shall be performed through the use of 2.5% phenylephrine and 1% tropicamide 3 times in five-minute increments. General anesthesia shall be performed. Skin sterilization shall be performed using an aqueous solution of 10% povidone-iodine. After the sterile surgical field is established and the eyelashes are isolated, 4 eye drops containing 5% povidone-iodine shall be administered in the conjunctival sac with subsequent irrigation using a 10% balanced salt solution. In cases of allergy to povidone-iodine, an aqueous solution of 0.05% chlorhexidine shall be used. The main incision (either a clear corneal incision or a scleral tunnel) will be 2.2 mm to 3.0 mm, and aspiration will be applied using the Infiniti® or Laureate® phacoemulsifier (Alcon) with a foldable AcrySof® intraocular lens (Alcon) and a posterior capsulotomy with an automated vitrectomy only in cases in which it is indicated.
Neither patients nor surgeons will be masked to the study treatment. The postoperative consultations will be held on the first, seventh, thirtieth, ninetieth, one hundred and twentieth, and one hundred and eightieth postoperative days and will include visual acuity assessments, refractive error assessments, keratometry , biomicroscopy, applanation tonometry, and fundoscopy, depending on the patient's age and ability to cooperate. If a necessary exam is not possible in a clinical setting, it will be performed under sedation in the surgical center.
Primary outcome: frequency of complications associated with sutures in each group.
Secondary outcome: need for suture removal under sedation in each group. The following will be defined as suture-related complications: corneal neovascularization close to the suture, loosening of the suture, accumulation of mucus on the suture, early rupture (within 2 weeks or less) of the suture, aqueous humor leakage through the incision (as determined by the Seidel test), prolapse of the iris through the incision site, infectious or traumatic keratitis, endophthalmitis and giant papillary conjunctivitis as observed in a biomicroscopy exam using a slit lamp.
Based on the frequency of suture-related complications described in the literature and using a two-tailed 95% confidence interval, 80% power, an exposed/unexposed radius of 1, and a null frequency of complications in the polyglactin suture group, approximately 40 subjects are needed for each group. UNICAMP performs an average of 75 pediatric cataract surgeries per year. Thus, there is a perspective for patient inclusion and study completion of just over one year.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vicryl | Experimental | Device: Vicryl sutureVicryl suture |
| Nylon | Active comparator | Device: Nylon sutureNylon suture |
Who may qualify
- Ages
- 30 days to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients up to 14 years of age who are clinically qualified to undergo pediatric cataract surgery
Key exclusion criteria (4 listed)
- Traumatic cataract with ocular perforation
- Cataract surgery associated with other procedures, such as glaucoma filtering surgery, vitreoretinal surgery, and cornea surgery
- Signs of ocular or periocular infection
- Advanced glaucoma
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 |
|---|---|---|
| Vicryl sutureCorneal suture with Vicryl suture | Device | Vicryl |
| Nylon sutureCorneal suture with Nylon suture | Device | Nylon |
Primary outcome
frequency of complications associated with sutures in each group
Time frame: 180 days
frequency of complications associated with sutures in each group
1 secondary outcome
need for suture removal under sedation in each group.
Time frame: 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2019.
- Background: PubMed 9278811Foster A, Gilbert C, Rahi J. Epidemiology of cataract in childhood: a global perspective. J Cataract Refract Surg. 1997;23 Suppl 1:601-4. doi: 10.1016/s0886-3350(97)80040-5.
- Background: PubMed 7585238Gilbert CE, Wood M, Waddel K, Foster A. Causes of childhood blindness in east Africa: results in 491 pupils attending 17 schools for the blind in Malawi, Kenya and Uganda. Ophthalmic Epidemiol. 1995 Jun;2(2):77-84. doi: 10.3109/09286589509057086.
- Background: PubMed 15111583Haargaard B, Wohlfahrt J, Fledelius HC, Rosenberg T, Melbye M. Incidence and cumulative risk of childhood cataract in a cohort of 2.6 million Danish children. Invest Ophthalmol Vis Sci. 2004 May;45(5):1316-20. doi: 10.1167/iovs.03-0635.
- BackgroundWHO | Priority eye diseases. WHO [Internet]. 2014 [cited 2017 Dec 29]; Available from: http://www.who.int/blindness/causes/priority/en/index3.html
- BackgroundWilson BME. Pediatric Cataracts : Overview Classification ( Categorization ). 2016;
- BackgroundHeaven CJ, Boase DL. Suppurative keratitis with endophthalmitis due to biodegraded full thickness monofilament nylon corneal sutures. Eur J Implant Refract Surg [Internet]. 1993;5(3):164-8. Available from: http://dx.doi.org/10.1016/S0955-3681(13)80436-4
- Background: PubMed 19393897Lee BJ, Smith SD, Jeng BH. Suture-related corneal infections after clear corneal cataract surgery. J Cataract Refract Surg. 2009 May;35(5):939-42. doi: 10.1016/j.jcrs.2008.10.061.
- Background: PubMed 10330655Culbert RB, Devenyi RG. Bacterial endophthalmitis after suture removal. J Cataract Refract Surg. 1999 May;25(5):725-7. doi: 10.1016/s0886-3350(99)00020-6.
- Background: PubMed 12900247Khurshid GS, Fahy GT. Endophthalmitis secondary to corneal sutures: series of delayed-onset keratitis requiring intravitreal antibiotics. J Cataract Refract Surg. 2003 Jul;29(7):1370-2. doi: 10.1016/s0886-3350(03)00404-8.
- Background: PubMed 2060657Acheson JF, Lyons CJ. Ocular morbidity due to monofilament nylon corneal sutures. Eye (Lond). 1991;5 ( Pt 1):106-12. doi: 10.1038/eye.1991.20. No abstract available.
- BackgroundDanjoux JP, Reck AC, to C. CORNEAL SUTURES: IS ROUTINE REMOVAL REALLY NECESSARY? [cited 2017 Dec 28]; Available from: https://www.nature.com/articles/eye199470.pdf
- Background: PubMed 9775239Bainbridge JW, Teimory M, Kirwan JF, Rostron CK. A prospective controlled study of a 10/0 absorbable polyglactin suture for corneal incision phacoemulsification. Eye (Lond). 1998;12 ( Pt 3a):399-402. doi: 10.1038/eye.1998.94.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vicryl suture and Nylon suture in people with Endophthalmitis and Cataracts Infantile, run by University of Campinas, Brazil 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 4 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: status not confirmed, as of the sponsor's last update on 25 Jan 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mathias Melega, MD (+55 19 997513150, mvmelega@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of complications associated with sutures in each group (time frame: 180 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 NCT03812640, which also lists 14 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 25 Jan 2019.