N/A
N=110
Negative Pressure Wound Therapy After Cesarean Delivery
Major Puerperal Infection, Postpartum · Wound Complications · Wound Seroma · Caesarean Section Wound Separation · Wound Infection
Bottom Line
View on ClinicalTrials.gov: NCT01637870 ↗Enrolled (actual)
110
Serious AEs
0.9%
Results posted
Apr 2018
Primary outcome: Primary: Wound Complication Rate — 3; 1; 3; 6 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Prevena negative pressure wound system (Device)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Abbey Hardy-Fairbanks
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Wound Complication Rate |
3; 1; 3; 6 | — |
Summary
This study is aimed at determining whether or not the use of a wound suction device placed on the cesarean incision instead of a standard sterile dressing will decrease the prevalence of wound complications and wound infections in women at high risk for post operative complications. The study will first look at the infection and wound complication rate in women 6 months prior to the start date of the study by reviewing charts of women who have undergone a cesarean section. The study involves placing a single use, portable wound vacuum over the cesarean section incision and keeping it in place for 72h. The investigators will then compare the rates of wound infection and wound complications between these two groups.
It is our hypothesis that negative pressure wound systems will decrease the wound infection and complication rate in this high risk population.
Eligibility Criteria
Inclusion Criteria
- 18 years old or older
- Having a cesarean delivery
- Has one or more of the following conditions:
- BMI > 30
- Anemia
- Preeclampsia (sever or mild)
- Hemolysis, elevated liver enzymes and low platelets (HELLP)
- Urgent procedure
- Rupture of membranes prior to surgery for > 4 hours
- Chorioamnionitis
- Hypertension
- Diabetes (Gestational or pre-gestational)
- Dense adhesive disease
Exclusion Criteria
- Age < 18 years old
- Unable to give informed consent
Data sourced from ClinicalTrials.gov (NCT01637870). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.