At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 100 enrolled
Drug / intervention
Insorb absorbable staples +1 moredevice
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.
Closure of Pfannenstiel Skin Incisions After Cesarean Delivery: A Comparison of Metallic Staples Versus Absorbable Staples
In Brief
A Phase 2 clinical trial evaluating Insorb absorbable staples and Insorb for Cesarean Section. Completed, enrolled 100 participants across 1 site.
Detailed Summary
The purpose of the study is to compare post operative pain, cost effectiveness, speed of closure and patient satisfaction of Pfannenstiel incisions closed with metallic staples versus absorbable staples (Insorb) after Cesarean Delivery.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCesarean Section
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2010
First PostedSep 2010
Primary CompletionMay 2011
TodayJul 2026
First PostedSep 10, 2010
Enrollment StartJul 1, 2010
Primary CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 15.8 years ago
Interventions
Insorb absorbable staplesdevice
Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples
Insorbdevice
Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples