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. Author manuscript; available in PMC: 2019 Feb 1.
Published in final edited form as: Am J Obstet Gynecol. 2017 Sep 23;218(2):200–210.e1. doi: 10.1016/j.ajog.2017.09.017

Table 1.

Characteristics of included studies

Author (et al.) Year Country Study Design Text Form Inclusion Criteria Exclusion Criteria Sample Size NPWT Device Used Quality
Chaboyer 2014 Australia RCT Full text
  1. Elective CS

  2. Pre-pregnany BMI≥30

  3. Able to provide written informed consent

  1. Urgent or emergent CS

  2. Previous participation in trial

  3. Existing infection between admission and CS

  4. Unable to speak or understand English

87 PICO High
Mark 2014 USA RC Full text
  1. BMI≥45

Not reported 69 KCI Low
Ruhstaller 2017 USA RCT Full text
  1. BMI≥30

  2. ≥4cm dilation at time of CS

  1. Initiation of prenatal care after 23 weeks

  2. Pre-existing diabetes, using chronic steroids or immunosuppressants, or active cancer treatment

  3. Allergy to silver

  4. Scheduled CS or planned vertical skin incision

119 Prevena High
Swift 2015 USA Mixed Full text Not reported Not reported 319 Prevena Low
Tuuli 2017 USA RCT Abstract
  1. BMI≥30

  1. Non-availability for post-op follow-up

  2. Pre-existing infection at incision site

  3. Bleeding disorder or anticoagulation

120 PICO High
Villers 2017 USA RC Abstract
  1. BMI≥40

Not reported 317 Not reported Low
Hyldig 2016 Denmark RCT PhD Thesis
  1. 18 years or older

  2. Pre-gestational BMI ≥30

  3. Giving birth by planned or emergent CS at one of five trial centers

  1. Non-Danish speakers

535 PICO High
Heine 2017 USA RCT Full text
  1. Female ≥18 years old

  2. Able to provide informed consent

  3. CS using subcuticular skin closure within the next 42 days

  4. Surgical incision able to be covered completely by PIMS

  5. BMI≥35 during screening period up to 42 days pre-surgery

  6. CDC wound classification of clean or clean contaminated

  7. Willing and able to return for all scheduled and required study visits

  8. Not enrolled in another

  1. ASA class P4, P5 or P6

  2. Systemic bacterial/fungal infection at time of surgery

  3. Remote-site skin infection at time of surgery

  4. Life expectancy <12 months

  5. Pre-operatively classified to undergo CDC wound classification of contaminated or dirty-infected

  6. Intraoperative hemorrhage requiring transfusion, DIC, or other medical condition that makes participant high risk

  7. Clinically significant condition that would impair compliance with study procedure

  8. Allergy or hypersensitivity to silver or drape materials

82 Prevena High
Stitely N/A USA RCT Clinical Trials.gov (NCT0065 4641)
  1. 18 years or older

  2. Weight >199 lbs

  3. Depth of subcutaneous tissue ≥4 cm

  1. Weight ≤199 lbs, or <4cm subQ tissue

  2. Inability to give proper informed consent

  3. Inability to adhere to follow-up

54 Not reported Low

Abbreviations: NPWT, negative pressure wound therapy; RCT, randomized controlled trial; RC, retrospective cohort.