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NCT01687972 · ClinicalTrials.gov registry record · Phase 1
INSORB Versus Subcuticular Sutures at Cesarean Section
A Phase 1 study, sponsored by Johns Hopkins University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 187
- Enrollment target
NCT01687972: Clinical Trial Phase 1 study, sponsored by Johns Hopkins University.
NCT01687972 is a Phase 1 study that was terminated before completion, run by Johns Hopkins University. The registered enrollment target is 187 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01687972, a Phase 1 study, was terminated before completion, sponsored by Johns Hopkins University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 187 participants
- Enrollment target
Study Summary
The proposed study is a randomized controlled trial with two arms. All patients admitted to Labor and Delivery at Johns Hopkins Hospital for delivery will be approached and offered entry into our study. Once the patient is enrolled, and if she undergoes a cesarean section, the patient will be randomized at time of cesarean section to receive skin closure by either the INSORB™ absorbable staples or subcuticular closure using Biosyn™ suture as is the standard practice. Both an observer scar assessment score (OSAS) and patient scar assessment score (PSAS) will be obtained during this visit. The patient will then be contacted by telephone by a study member 3 months after her surgery for a brief survey (same PSAS survey) assessing her satisfaction with the resulting scar.
Interventions
- COMBINATION_PRODUCT Insorb absorbable staples
- COMBINATION_PRODUCT Absorbable sutures
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 187 participants |
| Start Date | 2011-09 |
| Est. Completion | 2012-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01687972
The ClinicalTrials.gov registry entry for NCT01687972 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 187 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 2 interventions - of which Insorb absorbable staples is the first listed.
NCT01687972 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01687972 about?
NCT01687972 is a clinical study titled "INSORB Versus Subcuticular Sutures at Cesarean Section". The proposed study is a randomized controlled trial with two arms. All patients admitted to Labor and Delivery at Johns Hopkins Hospital for delivery will be approached and offered entry into our study. Once the patient is enrolled, and if she undergoes a cesarean section, the patient will be random...
What is the current status of trial NCT01687972?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 187 participants. The study started on 2011-09. Estimated completion is 2012-08.
What interventions are being tested in trial NCT01687972?
The interventions under investigation include: Insorb absorbable staples (COMBINATION_PRODUCT), Absorbable sutures (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT01687972?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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