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Negative Pressure Wound Therapy

PICO Negative Pressure Wound Therapy for Cesarean Section Complications

Phase 3
Waitlist Available
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 42 days
Awards & highlights

Study Summary

This trial will compare surgical site occurrences and interventions in obese women who have the current standard-of-care dressing versus the PICO NPWT.

Eligible Conditions
  • Cesarean Section Complications
  • Cesarean Wound Dehiscence
  • Cesarean Wound Disruption

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~42 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 42 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Surgical Site Occurrence
Secondary outcome measures
Surgical Incision Intervention

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PICO DressingExperimental Treatment1 Intervention
PICO Negative Pressure Wound Therapy (Smith and Nephew Healthcare, Hull, United Kingdom) is a non-significant-risk, FDA Class II, medical device commercially available in the USA. The PICO unit is a single patient use, battery-powered, disposable unit that can provide continuous 80 - 125 mmHg negative pressure over a 5 to 7-day therapy period.
Group II: Standard DressingActive Control1 Intervention
The standard-of-care is consistent with the national standard for dressing Cesarean section incisions and includes, but not limited to, coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™). The non-penetrable barrier may be left in place for a minimum of 1 day and no longer than 2 days (± 4 hours) to promote epithelialization of the surgical incision edges. After the dressing is removed, the surgical site is left exposed to air to promote further healing.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PICO Negative Pressure Wound Therapy
2019
Completed Phase 3
~160

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor
458 Previous Clinical Trials
470,780 Total Patients Enrolled
Gary Goldberg, MDStudy ChairLong Island Jewish Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
PICO Negative Pressure Wound Therapy in Obese Women Undergoing Elective Cesarean Delivery.
Anar Yukhayev 2019. "PICO Negative Pressure Wound Therapy in Obese Women Undergoing Elective Cesarean Delivery.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03414762.
~25 spots leftby Apr 2025
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