Cesarean SectionNCT02839005
Absorbable Suture Versus Nonabsorbable Suture Intradermal for the Skin Transverse Section in Cesarean
A study testing Continuous suture with polyglecaprone 25 and Continuous suture with polyamide (nylon) in people with Cesarean Section and Sutures, run by Universidade do Vale do Sapucai at 1 site in Brazil.
Trial summary
Context: Cesarean section is the most common surgery in women, both in developed and underdeveloped countries. However results are conflicting report in which material for intradermal suturing get better aesthetic result. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean Section, Sutures
- What is being tested?
- Continuous suture with polyglecaprone 25 and Continuous suture with polyamide (nylon)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2015to Jan 2016
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who underwent cesarean section
- No restriction of ethnicity, education or social class
Who cannot join
- Scarring Pfannenstiel prior
- Diabetic patients using drugs;
- Patients with collagen diseases
- Patients with pre operative tests to indicate any systemic sign of infection or site, not previously treated until the time of surgery.
- Patients who withdrew informed consent
- Patients who did not attend the pre scheduled dates for the controls after surgery .
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clínicas Samuel Libânio
Pouso Alegre, Minas Gerais, 37550-000
About this study
Context: Cesarean section is the most common surgery in women, both in developed and underdeveloped countries. However results are conflicting report in which material for intradermal suturing get better aesthetic result. Objective: To compare the aesthetic appearance of two suture materials, polyglecaprone 25 and polyamide (nylon) with intradermal sutures for skin closure in women undergoing cesarean section first. Methods: This is a clinical, prospective and randomized study which was conducted in the Department of Gynecology and Obstetrics of a tertiary Institute, Hospital das Clinicas Samuel Libânio, in PousoAlegre, Estate of Minas Gerais. Sixty women undergoing cesarean section were first included and randomized into two groups: group I (n = 30) polyamide and group II (n = 30) polyglecaprone 25. Hypertrophy, color and width of the wound were evaluated, receiving a score, according to Trimbos table, six months after surgery. Later the results were compared to non-parametric statistical tests
- Conditions
- Cesarean Section, Sutures
- Being tested
- Continuous suture with polyglecaprone 25, Continuous suture with polyamide (nylon)
- Keywords
- Wound Closure Thechnical, Wound Healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous suture with polyglecaprone 25Other
At the end of surgical procedemento of cesarean delivery , for skin closure continuous suture was performed with polyglecaprone 25
Continuous suture with polyamide (nylon)Other
At the end of surgical procedemento of cesarean delivery , for skin closure continuous suture was performed with polyamide (nylon)
| Study group | Role | What they receive |
|---|---|---|
| suture with polyglecaprone 25 | Active comparator | Not described Receives: Other: Continuous suture with polyglecaprone 25 |
| suture with polyamide (nylon) | Active comparator | Not described Receives: Other: Continuous suture with polyamide (nylon) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Photographic documentation for evaluation
The photographic record was sent to three experts for evaluation of hypertrophy and cross marks staining points, according Trimboset al.,1993
Measured: 6 Months
Photographic documentation for evaluation
The photographic record was sent to another expert for evaluation of hypertrophy and cross marks staining points, according Trimboset al.,1993, besides scar mesure
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startApr 2015
- Primary completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Vale do Sapucai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberta Junqueira Lima, Universidade do Vale do Sapucai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02839005
- Sponsor's protocol ID
- MRJ
- Status last verified
- Jul 2016
- First submitted
- 18 Jul 2016
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Absorbable Suture Versus Nonabsorbable Suture Intradermal for the Skin Transverse Section in Cesarean
- ClinicalTrials.gov ID
- NCT02839005
- Acronym / sponsor ID
- MRJ
- Conditions
- Cesarean Section, Sutures
- Keywords
- Wound Closure Thechnical, Wound Healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidade do Vale do SapucaiUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jan 2016 (actual)
- First posted
- 20 Jul 2016 (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.
Context: Cesarean section is the most common surgery in women, both in developed and underdeveloped countries. However results are conflicting report in which material for intradermal suturing get better aesthetic result. Objective: To compare the aesthetic appearance of two suture materials, polyglecaprone 25 and polyamide (nylon) with intradermal sutures for skin closure in women undergoing cesarean section first. Methods: This is a clinical, prospective and randomized study which was conducted in the Department of Gynecology and Obstetrics of a tertiary Institute, Hospital das Clinicas Samuel Libânio, in PousoAlegre, Estate of Minas Gerais. Sixty women undergoing cesarean section were first included and randomized into two groups: group I (n = 30) polyamide and group II (n = 30) polyglecaprone 25. Hypertrophy, color and width of the wound were evaluated, receiving a score, according to Trimbos table, six months after surgery. Later the results were compared to non-parametric statistical tests
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| suture with polyglecaprone 25 | Active comparator | Other: Continuous suture with polyglecaprone 25 |
| suture with polyamide (nylon) | Active comparator | Other: Continuous suture with polyamide (nylon) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who underwent cesarean section
- No restriction of ethnicity, education or social class
Key exclusion criteria (6 listed)
- Scarring Pfannenstiel prior
- Diabetic patients using drugs;
- Patients with collagen diseases
- Patients with pre operative tests to indicate any systemic sign of infection or site, not previously treated until the time of surgery.
- Patients who withdrew informed 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 |
|---|---|---|
| Continuous suture with polyglecaprone 25At the end of surgical procedemento of cesarean delivery , for skin closure continuous suture was performed with polyglecaprone 25 | Other | suture with polyglecaprone 25 |
| Continuous suture with polyamide (nylon)At the end of surgical procedemento of cesarean delivery , for skin closure continuous suture was performed with polyamide (nylon) | Other | suture with polyamide (nylon) |
Primary outcome
Photographic documentation for evaluation
Time frame: 6 Months
The photographic record was sent to three experts for evaluation of hypertrophy and cross marks staining points, according Trimboset al.,1993
Photographic documentation for evaluation
Time frame: 6 Months
The photographic record was sent to another expert for evaluation of hypertrophy and cross marks staining points, according Trimboset al.,1993, besides scar mesure
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 20 Jul 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous suture with polyglecaprone 25 and Continuous suture with polyamide (nylon) in people with Cesarean Section and Sutures, 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 2 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 20 Jul 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 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?
Photographic documentation for evaluation (time frame: 6 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2016.