ObesityNCT04458415
The Effect of Traxi Panniculus Retractor on Surgical Time at Non-emergent Cesarean Delivery in Obese Women
A study testing Traxi Panniculus Retractor (TPR) and Silk Tape in people with Obesity, run by Geisinger Clinic at 1 site in United States.
Trial summary
This is an unblinded, randomized control trial of obese women to evaluate the impact of the Traxi Panniculus Retractor (TPR) on the cesarean operative time and surgical blood loss when compared to silk tape. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Obesity
- What is being tested?
- Traxi Panniculus Retractor (TPR) and Silk Tape
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 30 Apr 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Current BMI equal to or greater than 30 kg/m2 at last prenatal visit or on day of admission to L\&D
- Requires panniculus retractor for cesarean delivery, as determined by the surgeon
- Non-emergent cesarean delivery
- Spinal or epidural anesthesia
- Low transverse skin incision
- Gestational age equal to or more than 32 weeks 0 days
Show all 9Show fewer
- Singleton pregnancy
- Three or less previous cesarean deliveries.
- English speaking
Who cannot join
- Use of Alexis or any other retractor
- General anesthesia
- Fetal demise
- Placenta previa
- History of bariatric surgery
- Adhesive allergy
Trial locations and contacts
1 site in 1 country.
United States1 site
Geisinger Medical Center
Danville, Pennsylvania, 17821
About this study
This is an unblinded, randomized control trial of obese women to evaluate the impact of the Traxi Panniculus Retractor (TPR) on the cesarean operative time and surgical blood loss when compared to silk tape.
Read the detailed description
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 time of delivery) women, can decrease the cesarean operative time compared to using silk tape to retract the panniculus. Operative time is defined as the time from when the patient lies on the operating room table (at completion of the epidural/spinal anesthesia) until fascial closure.
- Conditions
- Obesity
- Being tested
- Traxi Panniculus Retractor (TPR), Silk Tape
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traxi Panniculus Retractor (TPR)Other
Surgeon uses the Traxi Panniculus Retractor (TPR) surgical retraction device to retract the panniculus during C-Section.
Silk TapeOther
Surgeon uses silk tape to retract the panniculus during C-Section.
| Study group | Role | What they receive |
|---|---|---|
| TPR Arm | Experimental | Surgeon will use the Traxi Panniculus Retractor to retract the panniculus during cesarean section. Receives: Other: Traxi Panniculus Retractor (TPR) |
| Silk Tape Arm | Active comparator | Surgeon will use silk tape to retract the panniculus during cesarean section. Receives: Other: Silk Tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from when a subject lies on the OR table to fascial closure
Measured: During surgery-Time from when a subject lies on the OR table to fascial closure
Secondary outcomes (4)
Time from skin incision to delivery
Measured: During surgery-skin incision to delivery
Time from hysterotomy to delivery
Measured: During surgery-hysterotomy to delivery
Time from skin incision to closure of fascia
Measured: During surgery-skin incision to closure of fascia
Time from skin incision to skin closure
Measured: During surgery-skin incision to skin closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start1 Jun 2021 (estimated)
- Primary completion30 Jan 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Why it stopped: Collaborator discontinued at this site to pursue the study with a different site.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Innovations
- Responsible party
- Sponsor
- Investigators
- Michael J Paglia, MD, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04458415
- Sponsor's protocol ID
- 2020-0361
- Status last verified
- Aug 2021
- First submitted
- 11 Jun 2020
- Last updated
- 11 Aug 2021
- 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 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Traxi Panniculus Retractor on Surgical Time at Non-emergent Cesarean Delivery in Obese Women
- ClinicalTrials.gov ID
- NCT04458415
- Acronym / sponsor ID
- 2020-0361
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Collaborator discontinued at this site to pursue the study with a different site.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Collaborators
- Clinical Innovations
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 30 Jan 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 7 Jul 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.
This is an unblinded, randomized control trial of obese women to evaluate the impact of the Traxi Panniculus Retractor (TPR) on the cesarean operative time and surgical blood loss when compared to silk tape.
Detailed description
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 time of delivery) women, can decrease the cesarean operative time compared to using silk tape to retract the panniculus. Operative time is defined as the time from when the patient lies on the operating room table (at completion of the epidural/spinal anesthesia) until fascial closure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TPR Arm | Experimental | Other: Traxi Panniculus Retractor (TPR)Surgeon will use the Traxi Panniculus Retractor to retract the panniculus during cesarean section. |
| Silk Tape Arm | Active comparator | Other: Silk TapeSurgeon will use silk tape to retract the panniculus during cesarean section. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Current BMI equal to or greater than 30 kg/m2 at last prenatal visit or on day of admission to L\&D
- Requires panniculus retractor for cesarean delivery, as determined by the surgeon
- Non-emergent cesarean delivery
- Spinal or epidural anesthesia
- Low transverse skin incision
Key exclusion criteria (6 listed)
- Use of Alexis or any other retractor
- General anesthesia
- Fetal demise
- Placenta previa
- History of bariatric surgery
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 Panniculus Retractor (TPR)Surgeon uses the Traxi Panniculus Retractor (TPR) surgical retraction device to retract the panniculus during C-Section. | Other | TPR Arm |
| Silk TapeSurgeon uses silk tape to retract the panniculus during C-Section. | Other | Silk Tape Arm |
Primary outcome
Time from when a subject lies on the OR table to fascial closure
Time frame: During surgery-Time from when a subject lies on the OR table to fascial closure
4 secondary outcomes
Time from skin incision to delivery
Time frame: During surgery-skin incision to delivery
Time from hysterotomy to delivery
Time frame: During surgery-hysterotomy to delivery
Time from skin incision to closure of fascia
Time frame: During surgery-skin incision to closure of fascia
Time from skin incision to skin closure
Time frame: During surgery-skin incision to skin closure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2021.
- Individual participant dataSharing planned: No
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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.
Michael J Paglia, MD principal investigator
Geisinger Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traxi Panniculus Retractor (TPR) and Silk Tape in people with Obesity, run by Geisinger Clinic at 1 site in United States.
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 9 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: withdrawn, as of the sponsor's last update on 11 Aug 2021. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Time from when a subject lies on the OR table to fascial closure (time frame: During surgery-Time from when a subject lies on the OR table to fascial closure). 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 11 Aug 2021.