Traxi Panniculus Retractor for Cesarean Delivery

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

141 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This prospective, open-label, randomized-controlled trial is designed to evaluate the use of the Traxi panniculus retractor-- a commercially available Class I FDA-exempt device will improve surgical outcomes, cardiopulmonary function, and provider/patient satisfaction in morbidly obese women undergoing cesarean delivery.

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 safety data is available for the Traxi Panniculus Retractor used in cesarean delivery?

The provided research does not contain any safety data related to the Traxi Panniculus Retractor or its variants. The studies focus on different aspects of anesthesia and analgesia during cesarean delivery, but none mention the Traxi Panniculus Retractor or similar devices. ^{1 2 3 4 5}

Is the Traxi Panniculus Retractor a promising treatment 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. This can make the surgery easier and potentially safer. ^{6 7 8 9 10}

What data supports the idea that Traxi Panniculus Retractor for Cesarean Delivery is an effective treatment?

The available research shows that while the Traxi Panniculus Retractor itself is not directly mentioned, a similar type of retractor, the OB/Mobius®, was studied. This study found that the OB/Mobius® retractor did not reduce post-operative pain compared to traditional retractors. However, it did offer improved visualization during surgery, especially for obese women, which can be beneficial for surgeons working without an assistant. This suggests that the Traxi Panniculus Retractor might also provide better visibility during cesarean deliveries, making it a potentially useful tool in certain situations. ^{6 7 11 12 13}

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

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]

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]

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 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 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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

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

2. England pubmed.ncbi.nlm.nih.gov

A randomized controlled trial comparing two types of retractors at caesarean delivery. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Oblique Angled Retractor for Lumboperitoneal Shunt Implantation via Lateral Abdominal Laparotomy. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

[The Vollmer hook--a new abdominal retractor]. [2019]

5. South Africa pubmed.ncbi.nlm.nih.gov

Alexis O-ring wound retractor versus traditional metal retractors for the prevention of postcaesarean surgical site infections. [2023]

6. United Arab Emirates pubmed.ncbi.nlm.nih.gov

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

7. England pubmed.ncbi.nlm.nih.gov

Patient-controlled analgesia for labour using remifentanil: a feasibility study. [2019]

8. Netherlands 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. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Intravenous dexmedetomidine during spinal anaesthesia for caesarean section: A meta-analysis of randomized trials. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

The antiemetic efficacy and safety of prophylactic metoclopramide for elective cesarean delivery during spinal anesthesia. [2022]

11. United States 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. [2021]

12. Japan pubmed.ncbi.nlm.nih.gov

Novel use of the Nathanson liver retractor to prevent postoperative transient liver dysfunction during laparoscopic gastrectomy. [2021]

13. Germany pubmed.ncbi.nlm.nih.gov

A clinical study of the LiVac laparoscopic liver retractor system. [2019]