Traxi Panniculus Retractor for Cesarean Delivery

No longer recruiting at 1 trial location

Overseen By Melissa Dzinoreva

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Disqualifiers: Fetal demise, Skin disruption, Adhesive allergy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how the Traxi panniculus retractor might improve surgery outcomes and satisfaction for women with a high body mass index (BMI) undergoing a planned C-section. The device lifts and holds back the belly skin during surgery, potentially easing the procedure for both patient and doctors. Participants will either use the Traxi device or undergo the standard method of belly skin retraction during their C-section. Pregnant women with a BMI of 40 or more, having a single baby through a planned C-section, may be suitable for this study. As an unphased trial, this study allows participants to contribute to innovative research that could enhance surgical experiences for future patients.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that the Traxi Panniculus Retractor is safe for use in cesarean delivery?

Research shows a lack of clear safety information for the Traxi Panniculus Retractor used in cesarean deliveries. This device is a Class I FDA-exempt device, considered low-risk and generally safe. Class I devices often include items like bandages or simple surgical tools.

Although specific safety studies are not mentioned, the device's FDA-exempt status suggests it is generally well-tolerated. Doctors use it during surgery to hold back tissue, aiding in more efficient procedures. However, discussing potential risks or benefits with a healthcare provider is important for understanding your specific situation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Traxi Panniculus Retractor because it offers a new way to manage the panniculus, or abdominal skin fold, during a cesarean delivery. Unlike standard methods, which often rely on medical taping or extra staff to hold back the panniculus, the Traxi device provides a hands-free solution, potentially improving efficiency and reducing the need for additional personnel. This innovative approach could lead to smoother, quicker deliveries and a more streamlined surgical process.

What evidence suggests that the Traxi panniculus retractor is effective for cesarean delivery?

Research has shown that the Traxi Panniculus Retractor, which participants in this trial may receive, can be very helpful during cesarean deliveries, especially for women who are obese. In one study, 74% of participants found it very effective in holding back the fold of skin and fat. The device also provides doctors with a better view during surgery, which is important for successful operations. Additionally, it may reduce the time needed for surgery, making the procedure faster and possibly safer. Overall, the Traxi retractor offers promising benefits during cesarean deliveries. ^{1 2 4 5 6}

Who Is on the Research Team?

Ai-ris Collier, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

This trial is for morbidly obese pregnant women with a BMI of 40 or higher who are planning a non-emergent cesarean delivery. They must be able to give informed consent and have a single baby. Women can't join if they have skin issues on their belly, an allergy to adhesives, or if the baby has passed away.

Inclusion Criteria

I am scheduled for a planned cesarean delivery.

Pregnant

BMI greater than or equal to 40 kg/m^2

Exclusion Criteria

Fetal demise

Known adhesive allergy

I have no skin issues (like cuts or rashes) on my belly.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cesarean delivery with either Traxi panniculus retraction or standard of care methods

1 day

1 visit (in-person)

Follow-up

Participants are monitored for surgical outcomes, cardiopulmonary function, and satisfaction post-delivery

6 to 8 weeks

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Traxi Panniculus Retractor

Trial Overview

The study is testing the Traxi panniculus retractor during cesarean deliveries in morbidly obese women to see if it improves surgical outcomes, breathing function during surgery, and satisfaction levels for both patients and healthcare providers.

How Is the Trial Designed?

Group I: Traxi panniculus retraction group Experimental Treatment 1 Intervention

The method of panniculus retraction will be the Traxi panniculus retraction (Clinical Innovations, LLC) by the provider.

Group II: Standard of care Active Control 1 Intervention

Standard methods of panniculus retraction as determined by individual provider (including medical taping, extra personnel for retraction)

Traxi Panniculus Retractor is already approved in United States for the following indications:

Approved in United States as Traxi Panniculus Retractor for:

• Cesarean delivery in morbidly obese women

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Clinical Innovations, LLC

Industry Sponsor

Trials

6

Recruited

1,000+

Brigham and Women's Hospital

Collaborator

Trials

1,694

Recruited

14,790,000+

Published Research Related to This Trial

In a study of 154 women undergoing caesarean delivery, the use of the OB/Mobius® self-retaining retractor did not result in any significant differences in post-operative pain levels compared to conventional retractors.

While the OB/Mobius® retractor did not improve pain outcomes, it may enhance surgical visibility, particularly in obese patients, suggesting it could be beneficial for surgeons working without assistance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial comparing two types of retractors at caesarean delivery. Hardy-Fairbanks, AJ., Mackenzie, T., McCarthy, M., et al.[2022]

In a study of 207 pregnant women undergoing elective cesarean sections, the use of the Alexis® O C-Section Retractor did not result in a lower rate of post-surgical site infections compared to traditional metal retractors, with no infections reported in either group after 30 days.

There were no significant differences in operative parameters such as delivery time, blood loss, or postoperative pain between the two groups, suggesting that the choice of retractor may be based on surgeon preference rather than efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alexis O-ring wound retractor versus traditional metal retractors for the prevention of postcaesarean surgical site infections. Mothiba, MS., Tshepuwane, TC., Adefolalu, AO., et al.[2023]

In a case series of 10 patients undergoing caesarean delivery, the combination of remifentanil and propofol for general anaesthesia maintained stable maternal blood pressure, indicating a generally safe anaesthetic approach.

While six infants experienced brief respiratory depression requiring assisted ventilation, all recovered quickly without the need for naloxone, and umbilical artery pH levels remained above 7.20, suggesting that the technique is safe under controlled conditions, though further studies are needed before routine use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

General anaesthesia with target controlled infusion of propofol for planned caesarean section: maternal and neonatal effects of a remifentanil-based technique. Van de Velde, M., Teunkens, A., Kuypers, M., et al.[2022]

The Vollmer retractor is a new surgical tool designed to be fixed onto the operating table, enhancing the application of traction during abdominal surgeries.

This retractor improves visibility in critical areas such as the subdiaphragmatic region and small pelvis, which can lead to better surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The Vollmer hook--a new abdominal retractor]. Herzog, U., Vollmer, W.[2019]

In a study of 70 patients undergoing cesarean delivery, the Transversalis Fascia Plane Block (TFPB) significantly reduced tramadol consumption in the first 24 hours post-surgery, indicating improved pain management compared to standard analgesia.

Patients receiving the TFPB reported lower pain scores during the first 3 hours and at the 12th hour after surgery, demonstrating its efficacy in providing effective postoperative analgesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of ultrasound-guided transversalis fascia plane block for postoperative analgesia in cesarean section: A prospective, randomized, controlled clinical trial. Serifsoy, TE., Tulgar, S., Selvi, O., et al.[2021]

In a study involving 21 women, remifentanil used in a patient-controlled analgesia device effectively reduced pain during labor, with 90% of participants reporting lower pain scores from baseline.

The analgesia provided by remifentanil was deemed safe, as there were no significant changes in fetal heart rate, and Apgar scores and cord blood gas analyses remained normal, indicating no adverse effects on the baby.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-controlled analgesia for labour using remifentanil: a feasibility study. Blair, JM., Hill, DA., Fee, JP.[2019]

Spinal anaesthesia using dexmedetomidine during caesarean sections significantly reduces the incidence of nausea and vomiting compared to control groups, making it a safer option for patients.

While dexmedetomidine is effective in lowering nausea and shivering, it is associated with a higher incidence of bradycardia, indicating a need for careful monitoring during its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous dexmedetomidine during spinal anaesthesia for caesarean section: A meta-analysis of randomized trials. Bao, Z., Zhou, C., Wang, X., et al.[2022]

Modified abdominal wall retractors have been developed to provide better exposure during thoracic and groin surgeries, which can improve surgical outcomes.

These modifications also aim to enhance the comfort and efficiency of surgical assistants by ensuring adequate visibility in challenging areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An improved retractor for cardiac and thoracic operations. McEnany, MT.[2019]

The development of an oblique-angled retractor, modified to a 60-degree bend and tapered tip, has been successfully used in approximately 30 lumboperitoneal shunt procedures, improving surgical access in the lateral position.

This new retractor design minimizes interference with the ribs and thighs, particularly in obese patients, ensuring accurate placement and enhancing the overall efficacy of the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oblique Angled Retractor for Lumboperitoneal Shunt Implantation via Lateral Abdominal Laparotomy. Yokoya, S., Oka, H.[2023]

The LiVac laparoscopic liver retractor system successfully achieved its performance and safety objectives in a clinical study involving 10 patients undergoing upper abdominal laparoscopic surgeries, such as cholecystectomy and gastric banding.

No serious or device-related adverse events were reported, indicating that the LiVac retractor can effectively retract the liver without causing significant trauma, and it eliminates the need for additional skin incisions, which could enhance surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A clinical study of the LiVac laparoscopic liver retractor system. Gan, P., Bingham, J.[2019]

The article titled 'Prevention of Emetic Episodes During Cesarean Delivery Performed Under Regional Anesthesia in Parturients' has been formally retracted due to concerns about the legitimacy of the study and its data.

The retraction was initiated after the author, Dr. Y. Fujii, and his institution failed to provide satisfactory justification for the study's validity as requested by the journal's editors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retraction Notice: Prevention of emetic episodes during cesarean delivery performed under regional anesthesia in parturients. Fujii, Y.[2022]

The study involved 85 patients undergoing laparoscopic gastrectomy and evaluated the impact of different retraction methods on liver function, specifically looking at serum AST and ALT levels post-surgery.

Using a disk with the Nathanson retractor and repositioning it every 30 minutes significantly reduced postoperative liver dysfunction, as indicated by lower AST and ALT levels compared to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel use of the Nathanson liver retractor to prevent postoperative transient liver dysfunction during laparoscopic gastrectomy. Hiramatsu, K., Aoba, T., Kamiya, T., et al.[2021]

In a study of 42 pregnant women undergoing elective cesarean delivery, intravenous metoclopramide significantly reduced the incidence of nausea and vomiting compared to a placebo, with rates of 14% versus 81%.

The use of metoclopramide did not negatively impact neonatal health, as all acid-base values were normal and neurobehavioral exams showed no significant differences between the metoclopramide and control groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The antiemetic efficacy and safety of prophylactic metoclopramide for elective cesarean delivery during spinal anesthesia. Lussos, SA., Bader, AM., Thornhill, ML., et al.[2022]

Citations

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clinicaltrials.gov

clinicaltrials.gov/study/NCT04458415

The Effect of Traxi Panniculus Retractor on Surgical Time ...

The purpose of the study is to assess whether using the Traxi Panniculus Retractor during cesarean section, in obese (BMI greater than or equal to 30kg/m2 at ...

2.

withpower.com

withpower.com/trial/phase-obesity-morbid-9-2018-6d0da

Traxi Panniculus Retractor for Cesarean Delivery

The Traxi Panniculus Retractor could be a promising treatment because it may improve the view for doctors during surgery, especially in patients who are obese.

3.

bidmc.theopenscholar.com

bidmc.theopenscholar.com/files/ai-ris-collier/files/presentations/neps-2025_oral_emily.pdf

Randomized controlled trial of Traxi panniculus retractor ...

How effective was this method for panniculus retraction? <0.001. Very. 74%. 38%. Somewhat/Undecided/Not.

4.

clinicaltrial.be

clinicaltrial.be/en/details/67424?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

Traxi Panniculus Retractor for Cesarean Delivery

The primary outcome evaluated will be operating time (incision to closure). Other secondary outcomes related to surgery including estimated ...

5.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/76/NCT03651076/Prot_SAP_ICF_000.pdf

NCT Number: NCT03651076 Official Title

AIM 1. Determine whether the use of traxi decreases surgical times in obese patients requiring panniculus retraction.

6.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0959289X24002693

Novel approaches facilitating neuraxial anesthesia ...

We describe two novel approaches to assist neuraxial anesthesia administration and positioning for cesarean delivery.