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Trial · NCT03009110

Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryNumber of Participants With Superficial or Deep Surgical Site Infections (SSIs)30 days postoperativelyAs defined according to the Center for Disease Control and Prevention's (CDC) National Healthcare Safety Network criteria.
SecondaryNumber of Participants With Superficial, Deep or Organ Space SSIs (Individual Types of SSIs)30 days postoperativelyAs defined according to the CDC's National Healthcare Safety Network criteria.
SecondaryNumber of Participants With Organ Space SSIs (Endometritis, Intraabdominal Abscess)30 days postoperativelyAs defined according to the CDC's National Healthcare Safety Network criteria.
SecondaryNumber of Participants With Wound Hematoma, Seroma, Separation (Other Wound Complications)30 days postoperativelyFrequency of wound hematoma, seroma, separation (other wound complications). Hematoma, seroma, separation (2cm or more).
SecondaryNumber of Participants With a Composite of Any Wound Complication Including SSI, Hematoma, Seroma, Separation (2cm or More).30 days postoperativelyFrequency of a composite of any wound complication including SSI, hematoma, seroma, separation (2cm or more). SSI, hematoma, seroma, separation (2cm or more).
SecondaryPatient Pain ScoreAt discharge, an average of 4 days postoperativelyOn a scale of 0 (least) - 10 (most).
SecondaryPatient Pain ScoreAt postoperative day 30On a scale of 0 (least) - 10 (most).
SecondaryPatient Satisfaction ScoreAt discharge, an average of 4 days postoperativelyOn a scale of 0 (least) - 10 (most).
SecondaryPatient Satisfaction ScoreAt postoperative day 30On a scale of 0 (least) - 10 (most).
Secondary
Number of Participants With Physician Office Visit, Emergency Room Visit, Attendance at Wound Clinic, Use Antibiotics, Hospital Readmission for Wound Related Problems (Measures of Healthcare Resource Utilization)
30 days postoperativelyFrequency of physician office visit, emergency room visit, attendance at wound clinic, use antibiotics, hospital readmission for wound related problems (measures of healthcare resource utilization).
SecondaryNumber of Participants With Skin Blistering, Erythema, Wound Bleeding (Measures of Adverse Skin Events)30 days postoperativelyFrequency of skin blistering, erythema, wound bleeding (measures of adverse skin events).
OtherTypes and Frequency of Different Bacteria Including Methicillin-resistant Staphylococcus Aureus30 days postoperativelyTypes and frequency of different bacteria including methicillin-resistant Staphylococcus aureus.
OtherIncremental Cost Per SSI Prevented30 days postoperativelyBased on economic analysis to be done along side trial. Results of the economic analysis will be published separately from the effectiveness and safety data.
OtherIncremental Cost Per Quality-Adjusted Life-year30 days postoperativelyBased on economic analysis to be done along side trial. Results of the economic analysis will be published separately from the effectiveness and safety data.
OtherRisk Factors for Surgical Site Infections in Obese Women30 days postoperativelyBased on combined cohort. Results of the risk factor analysis will be published separately from the effectiveness and safety data.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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