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NCT03195322 · ClinicalTrials.gov registry record · NA
Pre-pectoral AlloDerm® to Reinforce Tissues in Tissue Expander Breast Reconstruction
A NA study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT03195322: Completed NA study, sponsored by Johns Hopkins University.
NCT03195322 is a NA study that has completed, run by Johns Hopkins University. The registered enrollment target is 20 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03195322, a NA study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study Summary
Primary Objective: • To describe postoperative static pain scores on the Pain Visual Analog Scale at Day 1 in a population of women undergoing bilateral mastectomy followed by immediate, bilateral pre-pectoral tissue expander breast reconstruction reinforced with AlloDerm® coverage. Secondary Objectives: * To describe postoperative static and dynamic pain scores on the Pain Visual Analog Scale and Brief Pain Inventory-Short Form at Day 1-60 after tissue expander placement * To describe nausea/vomiting, and opioid use at Day 1, 2, 3, 7, 30, and 60 after mastectomy and tissue expander placement. * To describe short-term changes in Quality of Life scores after mastectomy and tissue expander placement. * To describe postoperative complication rates at Day 1, 2, 3, 7, 30, and 60 after mastectomy and tissue expander placement. * To describe nausea/vomiting, and opioid use at Day 1, 2, 3, 7, 30, and 60 after final reconstruction with tissue expander exchange for permanent implant. * To describe short-term changes in Quality of Life scores after final reconstruction with tissue expander exchange for permanent implant. * To describe postoperative complication rates at Day 1, 2, 3, 7, 30, and 60 after final reconstruction with tissue expander exchange for permanent implant. * To describe postoperative rates of breast animation deformity at Day 7, 30, and 60 after final reconstruction with tissue expander exchange for permanent implant. * To describe average hospital length of stay in patients after final reconstruction with tissue expander exchange for permanent implant. * To describe the patient's final assessment of pre-pectoral reconstruction from free-form text. Tertiary Objectives: • To measure cosmetic result and associated residual pain with Alloderm® reinforcement of breast pocket.
Interventions
- PROCEDURE Pre-pectoral Tissue Expander
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2017-10-01 |
| Est. Completion | 2021-12-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03195322
The ClinicalTrials.gov registry entry for NCT03195322 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Pre-pectoral Tissue Expander is the first listed.
NCT03195322 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03195322 about?
NCT03195322 is a clinical study titled "Pre-pectoral AlloDerm® to Reinforce Tissues in Tissue Expander Breast Reconstruction". Primary Objective: • To describe postoperative static pain scores on the Pain Visual Analog Scale at Day 1 in a population of women undergoing bilateral mastectomy followed by immediate, bilateral pre-pectoral tissue expander breast reconstruction reinforced with AlloDerm® coverage. Secondary Obje...
What is the current status of trial NCT03195322?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2017-10-01. Estimated completion is 2021-12-10.
What interventions are being tested in trial NCT03195322?
The interventions under investigation include: Pre-pectoral Tissue Expander (PROCEDURE).
Who is sponsoring clinical trial NCT03195322?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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