CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 278 enrolled
Drug / intervention
ABBy® Adjustable Panniculus Retractor for Wound Caredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04797637
NCT04797637N/ACompleted

Post-operative Patient Positioning Device for Improvement of Post-Operative Pain in Parturients Undergoing Cesarean Delivery: A Randomized Controlled Trial

Vanderbilt University Medical Center·interventional·Posted Mar 15, 2021·Updated Aug 22, 2023

In Brief

A clinical study evaluating ABBy® Adjustable Panniculus Retractor for Wound Care for Pain, Postoperative. Completed, enrolled 278 participants across 1 site.

Detailed Summary

This paucity of evidence supporting or dissuading the use of postoperative abdominal support following cesarean section for the reduction of postoperative pain leaves important clinical questions unanswered. Additionally, there is an absence of long-term outcomes associated with the use of abdominal support devices. There remains a need for the development and implementation of nonpharmacologic methods for analgesia for women following cesarean sections, along with evidence-based recommendations regarding their use in postoperative patients. The ABBy (G-Squared Medical, Brentwood, TN) is an extended-wear panniculus retractor/tissue stabilizer that is intended for use postoperatively after abdominal procedure. It is placed directly onto patient skin, superior to a transverse incision, and is then used to elevate redundant tissues away from an incision or wound (https://www.gsquaredmedical.com/How-it-Works.html). The ABBy can be removed and replaced by patients and can be used for up to 10 days. This study aims to assess the effect of ABBy use on postoperative pain, pain medication requirement, and patient satisfaction, when used as a patient-positioning device in women following cesarean delivery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMar 15, 2021
Enrollment StartApr 1, 2021
Primary CompletionJul 20, 2022
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 5.3 years ago

Interventions

ABBy® Adjustable Panniculus Retractor for Wound Caredevice

The ABBy (G-Squared Medical, Brentwood, TN) is an extended-wear panniculus retractor/tissue stabilizer that is intended for use postoperatively after abdominal procedure. It is placed directly onto patient skin, superior to a transverse incision, and is then used to elevate redundant tissues away from an incision or wound (https://www.gsquaredmedical.com/How-it-Works.html). The ABBy can be removed and replaced by patients and can be used for up to 10 days. This study aims to assess the effect of ABBy use on postoperative pain, pain medication requirement, and patient satisfaction, when used as a patient-positioning device in women following cesarean delivery.