N/A
N=120
Prophylactic Incisional Care in Obese Women at Cesarean
Wound Infections
Bottom Line
View on ClinicalTrials.gov: NCT02578745 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Number of Participants With Composite Surgical Site Infection (SSI) or Other Wound Complication. — 5; 3 Participants — p=0.72
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Prophylactic NPWT (PICO system) (Device); Standard Dressing (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- Washington University School of Medicine
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Composite Surgical Site Infection (SSI) or Other Wound Complication. |
5; 3 | 0.72 |
| SECONDARY Number of Participants With Any COMPONENT of SSI or Composite Wound Complication |
5; 3 | 0.72 |
| SECONDARY Pain Score on a 0 to 10 on Likert Scale |
0; 1 | 0.02 sig |
| SECONDARY Number of Participants With Positive Wound Culture |
0; 0 | >0.99 |
| SECONDARY Number of Participants With Methicillin-resistant Staphylococcus Aureus. |
0; 0 | >0.99 |
| SECONDARY Number of Participants With Any Prophylactic Negative Pressure-related Adverse Events. |
2; 0 | 0.50 |
Summary
Surgical site infections (SSIs) complicate 5 - 12% of cesareans. Negative pressure wound therapy (NPWT) - a closed, sealed system that applies negative pressure to the wound surface - has been used to treat open wounds since the late 1990s. Experimental evidence suggests NPWT promotes wound healing by removing exudate, approximating the wound edges, and reducing bacterial contamination. Although effectiveness of prophylactic NPWT is biologically plausible and non-randomized studies suggest benefit in reducing SSIs, good quality data is lacking. The objective of this pilot randomized controlled trial of 120 patients to test the hypothesis that prophylactic NPWT will reduce SSIs and other wound complications after cesarean in obese women. The investigators will randomly assign obese women undergoing cesarean delivery to Standard dressing or prophylactic NPWT with the PICO system after skin closure. The primary outcome will be a composite of superficial or deep SSIs per Centers for Disease Control and Prevention (CDC) criteria and other wound complications (separation, hematoma, seroma) after cesarean.
Secondary outcomes will include wound dehiscence (≥2 cm); hematoma; seroma; composite of wound complications; patient pain and satisfaction scores; physician office visit or emergency department (ED) visits for SSIs; and hospital readmission for wound complications.
Eligibility Criteria
Inclusion Criteria
- Gestational age ≥23weeks
- BMI≥30 at the time of delivery
- Planned or unplanned cesarean delivery (procedure in which NPWT is being tested)
Exclusion Criteria
- Non-availability for postoperative follow-up (follow-up is needed to ascertain study outcomes)
- Contraindication to NPWT applicable to women undergoing cesarean (device will not be used in patients with contraindications): Pre-existing infection around incision site, Bleeding disorder, Therapeutic anticoagulation, Allergy to any component of the dressing (e.g. silicone, adhesive tape)
Data sourced from ClinicalTrials.gov (NCT02578745). 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.