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N/A N=278 Randomized Treatment

Post-operative Patient Positioning Device for Improvement of Post-Operative Pain

Pain, Postoperative

Enrolled (actual)
278
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcome: Primary: Total Morphine Milliequivalent (MME) Use Postoperatively After Cesarean Delivery — 52; 68 Morphine milligram equivalents

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
ABBy® Adjustable Panniculus Retractor for Wound Care (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
Vanderbilt University Medical Center
Primary completion
Jul 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Total Morphine Milliequivalent (MME) Use Postoperatively After Cesarean Delivery
52; 68
SECONDARY
Subjective Pain Scores During Use of Patient Positioning Device
50; 51; 25; 30
SECONDARY
Patient Satisfaction During Use of Patient Positioning Device.
30; 33; 24; 12; 1
SECONDARY
Duration of Use of Patient Positioning Device.
5
SECONDARY
Number of Participants With Surgical Complications in Groups With and Without Patient Positioning Device
1; 1; 2; 0; 0; 0
SECONDARY
Surgical Costs in Groups With and Without Patient Positioning Device

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.

Eligibility Criteria

Inclusion Criteria

  • Age > 18 years
  • Cesarean delivery
  • 14 consecutive days during pregnancy)
  • Allergy to device adhesive
  • Active COVID-19 infection
  • Patient unable to consent
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04797637). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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