Suture Line InfectionNCT04220294
Subcutaneous Continuous Versus Interrupted Sutures During Cesarean Section.
A study testing Subcutaneous tissue closure in people with Suture Line Infection, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
A comparison of the rate of surgical site infections after cesarean section depending on the type of suture used for subcutaneous closure-continuous versus interrupted. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Suture Line Infection
- What is being tested?
- Subcutaneous tissue closure
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,238 participants
- Where
- 1 siteIsrael
- Study dates
- 10 Jan 2020to 20 Oct 2022
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women undergoing elective cesarean section.
- Subcutaneous tissue layer>2 centimeter according to ultrasound.
Who cannot join
- Non-elective CS.
- Fever during the 48 hours prior to surgery.
- Antibiotic treatment during the 48 hours prior to surgery.
- Inability to give informed consent.
- Preterm delivery (< 37 weeks' gestation).
- Fetal death.
- Known fetal anomalies or placental abnormalities.
- Immunosuppressive conditions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgical Site Infection Rate After Subcutaneous Continuous Versus Interrupted Sutures During Cesarean Section.
A comparison of the rate of surgical site infections after cesarean section depending on the type of suture used for subcutaneous closure-continuous versus interrupted.
Read the detailed description
Patients at term that are candidates for elective cesarean section will receive an explanation regarding the study and sign informed consent. Patients will then be divided randomly to one of 2 treatment groups based on the type of subcutaneous tissue closure:
- Interrupted sutures.
- Continuous sutures. Information regarding medical and obstetric history will be collected for each patient.
- Conditions
- Suture Line Infection
- Being tested
- Subcutaneous tissue closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous tissue closureProcedure or surgery
Subcutaneous tissue closure with 2-0 vicryl suture.
| Study group | Role | What they receive |
|---|---|---|
| Interrupted sutures | Active comparator | Subcutaneous tissue closure by interrupted sutures. Receives: Procedure: Subcutaneous tissue closure |
| Continuous sutures | Active comparator | Subcutaneous tissue closure by continuous sutures. Receives: Procedure: Subcutaneous tissue closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infection rate.
Surgical site infection rate.
Measured: From admission up to 6 weeks postpartum.
Secondary outcomes (17)
Rate of re-admission due to surgical site infection.
rate of re-admission within 6 weeks postpartum due to surgical site infection.
Measured: From admission up to 6 weeks postpartum.
Rate of postoperative febrile morbidity.
Rate of maternal body temperature > 38°C.
Measured: From admission up to 6 weeks postpartum.
Rate of maternal fever.
Rate of maternal fever in degrees celsius.
Measured: From admission up to 6 weeks postpartum.
Duration of maternal fever.
Duration of maternal fever in days.
Measured: From admission up to 6 weeks postpartum.
Rate of antibiotic use for the treatment of surgical site infection.
Rate of antibiotic use for the treatment of surgical site infection.
Measured: From admission up to 6 weeks postpartum.
Cesraean section-to-surgical site infection time interval.
Cesraean section-to-surgical site infection time interval in days.
Measured: From admission up to 6 weeks postpartum.
Rate of bacteremia.
Rate of bacteremia.
Measured: From admission up to 6 weeks postpartum.
Rate of sepsis.
Rate of sepsis.
Measured: From admission up to 6 weeks postpartum.
Post-operative duration of hospitalization.
Post-operative duration of hospitalization in days.
Measured: From admission up to 6 weeks postpartum.
Postoperative pain.
Postoperative pain based on the visual analogue scale score ranging from 0-10.
Measured: From admission up to 6 weeks postpartum.
Rate of postoperative anemia.
Rate of a hemoglobin level of under 10 gr/dL
Measured: From admission up to 6 weeks postpartum.
Blood transfusion rates.
Blood transfusion rates (recommended to patients with a postpartum hemoglobin level of under 7 gr/dL or between 7-8 gr/dL if anemia related symptoms are present)
Measured: From admission up to 6 weeks postpartum.
Breastfeeding rates.
Breastfeeding rates.
Measured: From admission up to 6 weeks postpartum.
rate of voiding problems.
Rate of need for either intermittent catheterization or 24-hour foley insertion to void
Measured: From admission up to 6 weeks postpartum.
Venous thromboembolism rates.
Venous thromboembolism rates.
Measured: From admission up to 6 weeks postpartum.
Rate of admission to intensive care unit.
Rates of admission to intensive care unit
Measured: From admission up to 6 weeks postpartum.
Maternal death rate
Maternal death rate.
Measured: From admission up to 6 weeks postpartum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start10 Jan 2020
- Primary completion30 Apr 2022
- Study completion20 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suture Line InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ROY LAUTERBACH MD, Rambam Health Care Campus
- Investigators
- Roy Lauterbach, MD, Principal investigator, Rambam Healthcare Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04220294
- Sponsor's protocol ID
- 0621-19-RMB
- Status last verified
- Feb 2023
- First submitted
- 5 Jan 2020
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Site Infection Rate After Subcutaneous Continuous Versus Interrupted Sutures During Cesarean Section.
- ClinicalTrials.gov ID
- NCT04220294
- Acronym / sponsor ID
- 0621-19-RMB
- Conditions
- Suture Line Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,238 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 20 Oct 2022 (actual)
- First posted
- 7 Jan 2020 (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.
A comparison of the rate of surgical site infections after cesarean section depending on the type of suture used for subcutaneous closure-continuous versus interrupted.
Detailed description
Patients at term that are candidates for elective cesarean section will receive an explanation regarding the study and sign informed consent. Patients will then be divided randomly to one of 2 treatment groups based on the type of subcutaneous tissue closure:
- Interrupted sutures.
- Continuous sutures. Information regarding medical and obstetric history will be collected for each patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interrupted sutures | Active comparator | Procedure: Subcutaneous tissue closureSubcutaneous tissue closure by interrupted sutures. |
| Continuous sutures | Active comparator | Procedure: Subcutaneous tissue closureSubcutaneous tissue closure by continuous sutures. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Pregnant women undergoing elective cesarean section.
- Subcutaneous tissue layer>2 centimeter according to ultrasound.
Key exclusion criteria (8 listed)
- Non-elective CS.
- Fever during the 48 hours prior to surgery.
- Antibiotic treatment during the 48 hours prior to surgery.
- Inability to give informed consent.
- Preterm delivery (< 37 weeks' gestation).
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 |
|---|---|---|
| Subcutaneous tissue closureSubcutaneous tissue closure with 2-0 vicryl suture. | Procedure or surgery | Continuous sutures, Interrupted sutures |
Primary outcome
Surgical site infection rate.
Time frame: From admission up to 6 weeks postpartum.
Surgical site infection rate.
17 secondary outcomes
Rate of re-admission due to surgical site infection.
Time frame: From admission up to 6 weeks postpartum.
Rate of postoperative febrile morbidity.
Time frame: From admission up to 6 weeks postpartum.
Rate of maternal fever.
Time frame: From admission up to 6 weeks postpartum.
Duration of maternal fever.
Time frame: From admission up to 6 weeks postpartum.
Rate of antibiotic use for the treatment of surgical site infection.
Time frame: From admission up to 6 weeks postpartum.
Cesraean section-to-surgical site infection time interval.
Time frame: From admission up to 6 weeks postpartum.
Rate of bacteremia.
Time frame: From admission up to 6 weeks postpartum.
Rate of sepsis.
Time frame: From admission up to 6 weeks postpartum.
Post-operative duration of hospitalization.
Time frame: From admission up to 6 weeks postpartum.
Postoperative pain.
Time frame: From admission up to 6 weeks postpartum.
Rate of postoperative anemia.
Time frame: From admission up to 6 weeks postpartum.
Blood transfusion rates.
Time frame: From admission up to 6 weeks postpartum.
Breastfeeding rates.
Time frame: From admission up to 6 weeks postpartum.
rate of voiding problems.
Time frame: From admission up to 6 weeks postpartum.
Venous thromboembolism rates.
Time frame: From admission up to 6 weeks postpartum.
Rate of admission to intensive care unit.
Time frame: From admission up to 6 weeks postpartum.
Maternal death rate
Time frame: From admission up to 6 weeks postpartum.
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 21 Feb 2023.
- Individual participant dataSharing planned: No
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.
Roy Lauterbach, MD principal investigator
Rambam Healthcare Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subcutaneous tissue closure in people with Suture Line Infection, run by Rambam Health Care Campus at 1 site in Israel.
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 8 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 21 Feb 2023. 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 Israel. 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?
Surgical site infection rate. (time frame: From admission up to 6 weeks postpartum.). 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 21 Feb 2023.