Chaboyer |
2014 |
Australia |
RCT |
Full text |
Elective CS
Pre-pregnany BMI≥30
Able to provide written informed consent
|
Urgent or emergent CS
Previous participation in trial
Existing infection between admission and CS
Unable to speak or understand English
|
87 |
PICO |
High |
Mark |
2014 |
USA |
RC |
Full text |
BMI≥45
|
Not reported |
69 |
KCI |
Low |
Ruhstaller |
2017 |
USA |
RCT |
Full text |
BMI≥30
≥4cm dilation at time of CS
|
Initiation of prenatal care after 23 weeks
Pre-existing diabetes, using chronic steroids or immunosuppressants, or active cancer treatment
Allergy to silver
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 |
BMI≥30
|
Non-availability for post-op follow-up
Pre-existing infection at incision site
Bleeding disorder or anticoagulation
|
120 |
PICO |
High |
Villers |
2017 |
USA |
RC |
Abstract |
BMI≥40
|
Not reported |
317 |
Not reported |
Low |
Hyldig |
2016 |
Denmark |
RCT |
PhD Thesis |
18 years or older
Pre-gestational BMI ≥30
Giving birth by planned or emergent CS at one of five trial centers
|
Non-Danish speakers
|
535 |
PICO |
High |
Heine |
2017 |
USA |
RCT |
Full text |
Female ≥18 years old
Able to provide informed consent
CS using subcuticular skin closure within the next 42 days
Surgical incision able to be covered completely by PIMS
BMI≥35 during screening period up to 42 days pre-surgery
CDC wound classification of clean or clean contaminated
Willing and able to return for all scheduled and required study visits
Not enrolled in another
|
ASA class P4, P5 or P6
Systemic bacterial/fungal infection at time of surgery
Remote-site skin infection at time of surgery
Life expectancy <12 months
Pre-operatively classified to undergo CDC wound classification of contaminated or dirty-infected
Intraoperative hemorrhage requiring transfusion, DIC, or other medical condition that makes participant high risk
Clinically significant condition that would impair compliance with study procedure
Allergy or hypersensitivity to silver or drape materials
|
82 |
Prevena |
High |
Stitely |
N/A |
USA |
RCT |
Clinical Trials.gov (NCT0065 4641) |
18 years or older
Weight >199 lbs
Depth of subcutaneous tissue ≥4 cm
|
Weight ≤199 lbs, or <4cm subQ tissue
Inability to give proper informed consent
Inability to adhere to follow-up
|
54 |
Not reported |
Low |