At a glance
ClinicalIndex Comparison RecordN/ACompleted· 154 enrolled
Drug / intervention
PICO Single Use Negative Pressure Wound Therapydevice
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.
Topical Negative Pressure Wound Therapy to Prevent Wound Complications Following Cesarean Section in High Risk Obstetric Patients
In Brief
A clinical study evaluating PICO Single Use Negative Pressure Wound Therapy for High Risk Pregnancy and Cesarean Wound Disruption With Postnatal Complication. Completed, enrolled 154 participants across 1 site.
Detailed Summary
This is a randomized controlled trial. Patients with a condition that increases their risk of a wound complication will be approached for inclusion in the trial. Each participant agreeing to study inclusion will be randomized to either suture alone or to closure of their skin incision with suture and then with prophylactic placement of a wound vac (PICO).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartJun 2015
First PostedMar 2017
Primary CompletionMar 2019
Study CompletionDec 2019
TodayJul 2026
First PostedMar 17, 2017
Enrollment StartJun 1, 2015
Primary CompletionMar 1, 2019
Study CompletionDec 1, 2019
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 9.3 years ago
Interventions
PICO Single Use Negative Pressure Wound Therapydevice
The PICO device will be placed over the closed cesarean section incision.