Prophylactic Incisional Care in Obese Women at Cesarean

Completed · Not applicable

Conditions studied: Wound Infections

In brief

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.

Key facts

Study ID

NCT02578745

Run by

Washington University School of Medicine

People needed

120

Starts

2015-10-01

Expected to finish

2016-03-01

Last updated by the study team

2019-11-27

Who can join

Age: any. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Gestational age ≥23weeks
• BMI≥30 at the time of delivery
• Planned or unplanned cesarean delivery (procedure in which NPWT is being tested)

You may not qualify if…

• 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)

Where it is running

• Barnes-Jewish Hospital — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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