Obese Patients Undergoing Cesarean SectionTraxiNCT02865083
The Effect of a Self-Retaining Pannus Retractor in Obese Patients Undergoing Cesarean Section
A study testing Traxi Pannus Retractor in people with Obese Patients Undergoing Cesarean Section, run by St. Louis University.
Trial summary
The purpose of this study is to investigate the effects of the Traxi Pannus retractor in obese patients (BMI ≥30 kg/m2) who undergo Cesarean sections compared to routine pannus retraction techniques. Read more about this study
- Who is it for?
- Ages 14 to 50 years, women only
- Conditions the study is for
- Obese Patients Undergoing Cesarean Section
- What is being tested?
- Traxi Pannus Retractor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2016to 2 Jan 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 14 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pregnant women with a BMI greater than or equal to 30 kg/m squared, aged 14-50 years old, undergoing non-emergent cesarean section for delivery and require pannus displacement for surgery.
- Physicians Inclusion would include any physician who routinely perform C-sections
Who cannot join
- Patients undergoing emergency Cesarean-section Pre-existing concurrent infection including chorioamnionitis State of immunosuppression (ie. HIV, cancer) Long-term steroid use (>2 days) Patients with a BMI <30 kg/m2, or those with a BMI >/=30kg who do not require pannus retraction.
- If there is a rash in the area of retraction Adhesive/tape allergy. Physicians exclusion would include any physician who does not routinely perform C-sections.
About this study
The purpose of this study is to investigate the effects of the Traxi Pannus retractor in obese patients (BMI ≥30 kg/m2) who undergo Cesarean sections compared to routine pannus retraction techniques. Patients will be randomized to the use of the Traxi retractor during Cesarean section (treatment group) or the use of traditional pannus retraction techniques (control group). The primary outcome to be followed is surgical site disruption. The investigators will also assess the duration of surgery or length of time from skin incision to delivery of the infant, change in hemoglobin, estimated blood loss, postoperative length of stay, need for hospital readmission or emergency room visits, or other complication rates between the two groups.
Read the detailed description
Surgical site infections (SSI) are an important cause of morbidity following cesarean sections. The rate of surgical site infections following cesarean section in the United States is estimated between 3-15%, depending on the population studied, definitions of surgical site infection used, and length of time studied and is often underestimated. Morbidities include longer length of hospital stay, hospital readmission, wound opening and re-exploration, need for home health care, increased health care costs and loss of productivity. The risk of developing a SSI after a Cesarean section is increased with certain patient characteristics, such as obesity and duration of surgery and is decreased with the use prophylactic antibiotics prior to the skin incision.
Obesity is a significant public health problem and the incidence continues to increase in the United States. It has been shown to be associated with increased risk of SSI after cesarean section in several studies. Olsen et al reviewed 1,605 patients who underwent cesarean section and found increased BMI at admission was an independent risk factor for SSI. In another study of 19,416 women in Israel who had cesarean deliveries, women who had a BMI ≥30 kg/m2 had an increased risk for infection (odds ratio [OR} =2.2; 95% Confidence Interval [CI]. Leth, et al. also found obesity as a risk factor associated with wound infection. In this study of 2,492 consecutive women who had cesarean sections in Denmark, infection rates increased with increasing BMI, with women with a BMI kg/m2 30.0-34.9 having an infection rate of 19.1% and women with a BMI of 35.0-39.9 kg/m2 and of ≥40 kg/m2 both having infection rates of 31.1%. Hypotheses for the increased rate of wound infections in obese patients include decreased vascularity of adipose tissue, increase in wound area, and poorer penetration of prophylactic antibiotics to adipose tissue. Adequate surgical exposure and good visualization are paramount in abdominal surgery. Retraction of the pannus cephalad is often required for adequate visualization and access to the lower abdomen and thus the lower uterine segment. Several studies have been shown that pfannensteil or joel-cohen incisions are superior to vertical incisions due to increased risk of classical cesarean delivery in the case of the obese gravida. Limited studies have been completed to assess supra umbilical incisions.
Other methods of pannus retraction are currently utilized in obstetrics surgery, mostly with surgical tape or Montgomery straps. However, there are currently no clinical trials comparing types of pannus retractors. Potential benefits from the Traxi retractor are decreased operating time, decreased need for additional operating room personnel, and increased ease of delivery of neonate. In addition, the Traxi is designed to stay on for 24 hours in order to elevate the pannus, this will decrease exposure to moisture and possibly other bacteria as the skin begins to heal.
- Being tested
- Traxi Pannus Retractor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traxi Pannus RetractorDevice
traxi® Panniculus Retractor is a retraction device used for retraction of the panniculus during surgical procedures. traxi retracts and holds the panniculus for the duration of the operation, freeing the surgeons hands and those of the staff to better care for the patient.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | Subjects will receive use of the Traxi pannus retractor when undergoing cesarean section Receives: Device: Traxi Pannus Retractor |
| Standard | No intervention | Patients will receive use of the standard of care option which is the montgomery straps |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Disruption Rates
To determine if there is a difference in wound disruption rates, in obese patients who have Cesarean sections when the Traxi retractor is used during Cesarean sections, when compared to traditional pannus retractor techniques, montogmery straps.
Measured: 24 hours from placement of device
Secondary outcomes (6)
Duration of Surgery or Length of Time From Skin Incision to Delivery of the Infant
To determine if there is a difference in duration of surgery or length of time from skin incision to delivery of the infant between the treatment group and the control/standard group.
Measured: At time of surgery
Change in Hemoglobin
To determine if there is a difference in change in hemoglobin between the control/standard group and the treatment group.
Measured: 24 hours after surgery
Estimated Blood Loss
To determine if there is a difference in estimated blood loss between the treatment group and the control/standard group.
Measured: At time of surgery
Postoperative Length of Stay
To determine if there is a difference in postoperative length of stay between the treatment group and the control/standard group.
Measured: 3-4 days
Other Complication Rate
To determine if there is a difference in other complication rates between the treatment group and the control/standard group.
Measured: 6 weeks
Need for Hospital Readmission or Emergency Room Visits
To determine if there is a difference in need for hospital readmission or emergency room visits between the treatment group and the control/standard group.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study start1 Jun 2016
- Primary completion2 Jan 2017
- Study completion2 Jan 2017
Why it stopped: unable to reach enrollment goal
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Obese Patients Undergoing 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Goldkamp, MD, St. Louis University
- Investigators
- Jennifer Goldkamp, MD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02865083
- Sponsor's protocol ID
- 26533
- Acronym
- Traxi
- Status last verified
- May 2018
- First submitted
- 4 Aug 2016
- Last updated
- 4 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Self-Retaining Pannus Retractor in Obese Patients Undergoing Cesarean Section
- ClinicalTrials.gov ID
- NCT02865083
- Acronym / sponsor ID
- Traxi / 26533
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: unable to reach enrollment goal
- Enrolment
- 4 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 2 Jan 2017 (actual)
- Study completion
- 2 Jan 2017 (actual)
- First posted
- 12 Aug 2016 (estimated)
- Results
- Posted 13 Apr 2018
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 investigate the effects of the Traxi Pannus retractor in obese patients (BMI ≥30 kg/m2) who undergo Cesarean sections compared to routine pannus retraction techniques. Patients will be randomized to the use of the Traxi retractor during Cesarean section (treatment group) or the use of traditional pannus retraction techniques (control group). The primary outcome to be followed is surgical site disruption. The investigators will also assess the duration of surgery or length of time from skin incision to delivery of the infant, change in hemoglobin, estimated blood loss, postoperative length of stay, need for hospital readmission or emergency room visits, or other complication rates between the two groups.
Detailed description
Surgical site infections (SSI) are an important cause of morbidity following cesarean sections. The rate of surgical site infections following cesarean section in the United States is estimated between 3-15%, depending on the population studied, definitions of surgical site infection used, and length of time studied and is often underestimated. Morbidities include longer length of hospital stay, hospital readmission, wound opening and re-exploration, need for home health care, increased health care costs and loss of productivity. The risk of developing a SSI after a Cesarean section is increased with certain patient characteristics, such as obesity and duration of surgery and is decreased with the use prophylactic antibiotics prior to the skin incision.
Obesity is a significant public health problem and the incidence continues to increase in the United States. It has been shown to be associated with increased risk of SSI after cesarean section in several studies. Olsen et al reviewed 1,605 patients who underwent cesarean section and found increased BMI at admission was an independent risk factor for SSI. In another study of 19,416 women in Israel who had cesarean deliveries, women who had a BMI ≥30 kg/m2 had an increased risk for infection (odds ratio [OR} =2.2; 95% Confidence Interval [CI]. Leth, et al. also found obesity as a risk factor associated with wound infection. In this study of 2,492 consecutive women who had cesarean sections in Denmark, infection rates increased with increasing BMI, with women with a BMI kg/m2 30.0-34.9 having an infection rate of 19.1% and women with a BMI of 35.0-39.9 kg/m2 and of ≥40 kg/m2 both having infection rates of 31.1%. Hypotheses for the increased rate of wound infections in obese patients include decreased vascularity of adipose tissue, increase in wound area, and poorer penetration of prophylactic antibiotics to adipose tissue. Adequate surgical exposure and good visualization are paramount in abdominal surgery. Retraction of the pannus cephalad is often required for adequate visualization and access to the lower abdomen and thus the lower uterine segment. Several studies have been shown that pfannensteil or joel-cohen incisions are superior to vertical incisions due to increased risk of classical cesarean delivery in the case of the obese gravida. Limited studies have been completed to assess supra umbilical incisions.
Other methods of pannus retraction are currently utilized in obstetrics surgery, mostly with surgical tape or Montgomery straps. However, there are currently no clinical trials comparing types of pannus retractors. Potential benefits from the Traxi retractor are decreased operating time, decreased need for additional operating room personnel, and increased ease of delivery of neonate. In addition, the Traxi is designed to stay on for 24 hours in order to elevate the pannus, this will decrease exposure to moisture and possibly other bacteria as the skin begins to heal.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Device: Traxi Pannus RetractorSubjects will receive use of the Traxi pannus retractor when undergoing cesarean section |
| Standard | No intervention | –Patients will receive use of the standard of care option which is the montgomery straps |
Who may qualify
- Ages
- 14 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Pregnant women with a BMI greater than or equal to 30 kg/m squared, aged 14-50 years old, undergoing non-emergent cesarean section for delivery and require pannus displacement for surgery.
- Physicians Inclusion would include any physician who routinely perform C-sections
Key exclusion criteria (2 listed)
- Patients undergoing emergency Cesarean-section Pre-existing concurrent infection including chorioamnionitis State of immunosuppression (ie. HIV, cancer) Long-term steroid use (>2 days) Patients with a BMI <30 kg/m2, or those with a BMI >/=30kg who do not require pannus retraction.
- If there is a rash in the area of retraction Adhesive/tape allergy. Physicians exclusion would include any physician who does not routinely perform C-sections.
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 |
|---|---|---|
| Traxi Pannus Retractortraxi® Panniculus Retractor is a retraction device used for retraction of the panniculus during surgical procedures. traxi retracts and holds the panniculus for the duration of the operation, freeing the surgeons hands and those of the staff to better care for the patient. | Device | Treatment |
Primary outcome
Wound Disruption Rates
Time frame: 24 hours from placement of device
To determine if there is a difference in wound disruption rates, in obese patients who have Cesarean sections when the Traxi retractor is used during Cesarean sections, when compared to traditional pannus retractor techniques, montogmery straps.
6 secondary outcomes
Duration of Surgery or Length of Time From Skin Incision to Delivery of the Infant
Time frame: At time of surgery
Change in Hemoglobin
Time frame: 24 hours after surgery
Estimated Blood Loss
Time frame: At time of surgery
Postoperative Length of Stay
Time frame: 3-4 days
Other Complication Rate
Time frame: 6 weeks
Need for Hospital Readmission or Emergency Room Visits
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Jennifer Goldkamp, MD principal investigator
St. Louis University
Questions about this trial
What is this clinical trial studying?
A study testing Traxi Pannus Retractor in people with Obese Patients Undergoing Cesarean Section, run by St. Louis University.
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 2 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: stopped early, as of the sponsor's last update on 4 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 13 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Wound Disruption Rates (time frame: 24 hours from placement of device). 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 4 Jun 2018.