Trial Outcomes & Findings for The Effect of a Self-Retaining Pannus Retractor in Obese Patients Undergoing Cesarean Section (NCT NCT02865083)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

24 hours from placement of device

Results posted on

2018-06-04

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Subjects will receive use of the Traxi pannus retractor when undergoing cesarean section Traxi Pannus Retractor: 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.	Standard Patients will receive use of the standard of care option which is the montgomery straps
Overall Study STARTED	3	1
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment Subjects will receive use of the Traxi pannus retractor when undergoing cesarean section Traxi Pannus Retractor: 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.	Standard Patients will receive use of the standard of care option which is the montgomery straps
Overall Study Early Termination	3	1

Baseline Characteristics

data were not collected

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=3 Participants Subjects will receive use of the Traxi pannus retractor when undergoing cesarean section Traxi Pannus Retractor: 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.	Standard n=1 Participants Patients will receive use of the standard of care option which is the montgomery straps	Total n=4 Participants Total of all reporting groups
Sex: Female, Male Female	3 Participants n=3 Participants	1 Participants n=1 Participants	4 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=3 Participants	0 Participants n=1 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: 24 hours from placement of device

Population: Patient data not collected

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At time of surgery

Population: Data were not collected.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hours after surgery

Population: Data were not collected

To determine if there is a difference in change in hemoglobin between the control/standard group and the treatment group.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At time of surgery

Population: Data were not collected.

To determine if there is a difference in estimated blood loss between the treatment group and the control/standard group.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3-4 days

Population: Data were not collected.

To determine if there is a difference in postoperative length of stay between the treatment group and the control/standard group.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Population: Data were not collected.

To determine if there is a difference in other complication rates between the treatment group and the control/standard group.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Population: Data were not collected.

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.

Outcome measures

Outcome data not reported

Adverse Events

Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jennifer Goldkamp, MD

Saint Louis University

Phone: 314-977-2574

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place