ChorioamnionitisCSCARNCT01988168
Closure of Skin in ChorioAmnionitis Research Pilot Study
A study testing Suture closure and Staples closure in people with Chorioamnionitis and Pregnancy Complications, Infectious, run by University of British Columbia at 1 site in Canada.
Trial summary
The purpose of the CSCAR pilot study is to improve the design of a full-scale trial by determining the patient recruitment rate and participation rate. The objective of the full-scale trial is to determine the optimal method of skin closure after Caesarean delivery in women with chorioamnionitis, which is an acute… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Chorioamnionitis, Pregnancy Complications, Infectious, Complications; Cesarean Section
- What is being tested?
- Suture closure and Staples closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2014to Dec 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of chorioamnionitis (Fever ≥ 38.0°C AND at least TWO of: Maternal tachycardia: Heart rate > 100bpm, Fetal tachycardia: Baseline heart rate > 160bpm, Uterine tenderness, Foul smelling / purulent vaginal discharge, White Blood Cell count > 15,000 cells/mm3)
- Caesarean delivery with Pfannenstiel incision
- Pregnancies >24 weeks
- Scheduled or non-elective procedures
- Primary or repeat Caesarean delivery
- No restrictions based on BMI
- No exclusions due to DM (GDM or non GDM)
- No exclusions due to multiple gestation pregnancy
Who cannot join
- Non-Pfannenstiel incision
- Immune compromising disease
- History of keloid formation
- Chronic steroid use
- Allergy to staples
- Planned postpartum care at another facility
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Children's and Women's Health Centre of British Columbia
Vancouver, British Columbia, V6H 3N1
Ellen M Giesbrecht, MD, 604-875-2424, egiesbrecht@cw.bc.ca
Ellen M Giesbrecht, MD
About this study
The purpose of the CSCAR pilot study is to improve the design of a full-scale trial by determining the patient recruitment rate and participation rate. The objective of the full-scale trial is to determine the optimal method of skin closure after Caesarean delivery in women with chorioamnionitis, which is an acute inflammation of the membranes and chorion of the placenta, seen typically after rupture of membranes with ascending polymicrobial bacterial infection. Women in labour with chorioamnionitis will be randomized at the time of Caesarean delivery to skin closure with either staples or sutures. The women will be followed at 6 weeks and 6 months post-partum in order to establish the occurrence of surgical site infection and wound disruption, as well as evaluation of the scar and other secondary questions.
The investigators hypothesis is that closure of skin with sutures will have a rate of wound infection that is no higher than the rate of wound infection when closing skin with staples. The investigators also hypothesize that closure with sutures will have a decreased rate of wound disruption, increased patient satisfaction and decreased length of hospital stay compared to skin closure with staples.
- Conditions
- Chorioamnionitis, Pregnancy Complications, Infectious, Complications; Cesarean Section, Postoperative Complications
- Being tested
- Suture closure, Staples closure
- Keywords
- Suture Techniques, Sutures, Surgical Staplers
- Medical subject headings
- Chorioamnionitis, Pregnancy Complications, Infectious, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suture closureProcedure or surgery
Also called 3-0 Monocryl suture (from Ethicon)
A running subcuticular suture is placed by taking horizontal bites through the papillary dermis on alternating sides of the wound. An absorbable suture is used and left in place until degraded and absorbed by the patient's tissues.
Staples closureProcedure or surgery
Surgical stapling devices re-appose skin edges with stainless steel or titanium staples. A second operator everts the wound skin edges while the operator applies staples along the incision. Staples can be removed on post-operative day 2 or 3, or delayed further according the surgeon preference based on patient characteristics.
| Study group | Role | What they receive |
|---|---|---|
| Suture closure | Experimental | Closure of skin with a running subcuticular, absorbable monofilament suture. Receives: Procedure: Suture closure |
| Staples closure | Active comparator | Closure of skin with stainless-steel surgical staples. Receives: Procedure: Staples closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient recruitment rate
The patient recruitment rate will be calculated as the total number of women successfully recruited to the trial divided by the total duration of the trial.
Measured: 1 year
Secondary outcomes (6)
Follow-up rates
Number of women successfully contacted at 6 weeks and at 6 months post-partum divided by the total number of women randomized in the trial
Measured: 6 months post-operative
Wound infection
Number of women who experience a wound infection divided by the total number of eligible women who participate in the trial.
Measured: 6 months post-operative
Wound disruption
Number of women who experience a wound disruption divided by the total number of eligible women who participate in the trial.
Measured: 6 months post-operative
Wound cosmesis
Wound cosmesis will be assessed using the POSAS Observer scale, which is directed at physicians, and the POSAS Patient scale, which is directed at patients
Measured: 6 months post-operative
Patient satisfaction
Using the POSAS Patient Scale, patient satisfaction will be assessed.
Measured: 6 months post-operative
Participation rate
The trial participation rate will be calculated as the percentage of eligible women who agreed to participate in the trial divided by the total number of eligible women approached to participate in the trial.
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 posted20 Nov 2013 (estimated)
- Study startFeb 2014
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChorioamnionitisStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- BC Children's Hospital Research Institute
- Responsible party
- Principal investigator, Ellen Giesbrecht, University of British Columbia
- Investigators
- Ellen M Giesbrecht, MD, Principal investigator, Clinical Assistant Professor, Division of General Gynaecology & Obstetrics, Department of Obstetrics and Gynaecology, University of British Columbia; Site Head, Department of Obstetrics, BC Women's HospitalJennifer A Hutcheon, PhD, Study director, Assistant Professor, Division of Maternal Fetal Medicine, Department of Obstetrics and Gynaecology, University of British ColumbiaJulie E van Schalkwyk, MD, Study director, Clinical Assistant Professor, Division of General Gynaecology & Obstetrics, Department of Obstetrics and Gynaecology, University of British ColumbiaMichael WH Suen, MD, Study director, Resident, Department of Obstetrics and Gynaecology, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01988168
- Sponsor's protocol ID
- H13-03009
- Acronym
- CSCAR
- Status last verified
- May 2017
- First submitted
- 31 Oct 2013
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closure of Skin in ChorioAmnionitis Research Pilot Study
- ClinicalTrials.gov ID
- NCT01988168
- Acronym / sponsor ID
- CSCAR / H13-03009
- Conditions
- Chorioamnionitis, Pregnancy Complications, Infectious, Complications; Cesarean Section, Postoperative Complications
- Keywords
- Suture Techniques, Sutures, Surgical Staplers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- BC Children's Hospital Research Institute
- Study start
- Feb 2014
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 20 Nov 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.
The purpose of the CSCAR pilot study is to improve the design of a full-scale trial by determining the patient recruitment rate and participation rate. The objective of the full-scale trial is to determine the optimal method of skin closure after Caesarean delivery in women with chorioamnionitis, which is an acute inflammation of the membranes and chorion of the placenta, seen typically after rupture of membranes with ascending polymicrobial bacterial infection. Women in labour with chorioamnionitis will be randomized at the time of Caesarean delivery to skin closure with either staples or sutures. The women will be followed at 6 weeks and 6 months post-partum in order to establish the occurrence of surgical site infection and wound disruption, as well as evaluation of the scar and other secondary questions.
The investigators hypothesis is that closure of skin with sutures will have a rate of wound infection that is no higher than the rate of wound infection when closing skin with staples. The investigators also hypothesize that closure with sutures will have a decreased rate of wound disruption, increased patient satisfaction and decreased length of hospital stay compared to skin closure with staples.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suture closure | Experimental | Procedure: Suture closureClosure of skin with a running subcuticular, absorbable monofilament suture. |
| Staples closure | Active comparator | Procedure: Staples closureClosure of skin with stainless-steel surgical staples. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Clinical diagnosis of chorioamnionitis (Fever ≥ 38.0°C AND at least TWO of: Maternal tachycardia: Heart rate > 100bpm, Fetal tachycardia: Baseline heart rate > 160bpm, Uterine tenderness, Foul smelling / purulent vaginal discharge, White Blood Cell count > 15,000 cells/mm3)
- Caesarean delivery with Pfannenstiel incision
- Pregnancies >24 weeks
- Scheduled or non-elective procedures
- Primary or repeat Caesarean delivery
Key exclusion criteria (6 listed)
- Non-Pfannenstiel incision
- Immune compromising disease
- History of keloid formation
- Chronic steroid use
- Allergy to staples
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 |
|---|---|---|
| Suture closureAlso: 3-0 Monocryl suture (from Ethicon)A running subcuticular suture is placed by taking horizontal bites through the papillary dermis on alternating sides of the wound. An absorbable suture is used and left in place until degraded and absorbed by the patient's tissues. | Procedure or surgery | Suture closure |
| Staples closureSurgical stapling devices re-appose skin edges with stainless steel or titanium staples. A second operator everts the wound skin edges while the operator applies staples along the incision. Staples can be removed on post-operative day 2 or 3, or delayed further according the surgeon preference based on patient characteristics. | Procedure or surgery | Staples closure |
Primary outcome
Patient recruitment rate
Time frame: 1 year
The patient recruitment rate will be calculated as the total number of women successfully recruited to the trial divided by the total duration of the trial.
6 secondary outcomes
Follow-up rates
Time frame: 6 months post-operative
Wound infection
Time frame: 6 months post-operative
Wound disruption
Time frame: 6 months post-operative
Wound cosmesis
Time frame: 6 months post-operative
Patient satisfaction
Time frame: 6 months post-operative
Participation rate
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
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Comparing Infectious Morbidity Among Women With Meconium-stained Amniotic Fluid at Term, Between Those Treated With Prophylactic Antibiotics Zinacef vs. Placebo
Meconium-stained Amniotic Fluid, Chorioamnionitis
Active, not recruitingObservational study
IL-6 and Lactates in Cord Blood and Neonatal Outcomes
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Enrolling by invitation
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Active, not recruitingObservational study
Association Between Neuraxial Labor Analgesia and Maternal and Neonatal Infectious Outcomes
Intrapartum Maternal Fever, Clinical Chorioamnionitis
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.
Ellen M Giesbrecht, MD principal investigator
Clinical Assistant Professor, Division of General Gynaecology & Obstetrics, Department of Obstetrics and Gynaecology, University of British Columbia; Site Head, Department of Obstetrics, BC Women's Hospital
Jennifer A Hutcheon, PhD study director
Assistant Professor, Division of Maternal Fetal Medicine, Department of Obstetrics and Gynaecology, University of British Columbia
Julie E van Schalkwyk, MD study director
Clinical Assistant Professor, Division of General Gynaecology & Obstetrics, Department of Obstetrics and Gynaecology, University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suture closure and Staples closure in people with Chorioamnionitis and Pregnancy Complications, Infectious, run by University of British Columbia at 1 site in Canada.
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 8 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: status not confirmed, as of the sponsor's last update on 12 May 2017. 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 Canada. 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 Ellen M Giesbrecht, MD (604-872-5484, egiesbrecht@cw.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient recruitment rate (time frame: 1 year). 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 12 May 2017.