title: A randomized controlled trial of early versus delayed skin staple removal following caesarean section in the obese patient.
abstract: OBJECTIVE
  To compare wound complications after Caesarean section in the obese patient, following early versus delayed skin staple removal.
  
  
  METHODS
  We conducted a single-centre, non-inferiority, randomized controlled trial. Following Caesarean section, obese women (BMI ≥ 30 kg/m(2)) with subcutaneous wound depth ≥ 2.0 cm and skin staple closure of a transverse incision were randomized to staple removal on postoperative day 3 (early) or between postoperative day 7 and postoperative day 10 (delayed). The primary outcome was superficial wound dehiscence; a rate of 8% or higher in the early group was defined as inferior. Secondary outcomes were seroma/hematoma, surgical site infection, and visual analogue pain score. The planned sample size was 250 patients per group.
  
  
  RESULTS
  The study was halted after 295 patients were randomized because of slow enrolment and exhaustion of funding. The rate of superficial wound dehiscence was 15.2% in the early group (n = 145) versus 11.5% in the delayed group (n = 148). The point estimate for this difference (3.7 %; 95% CI -4.4 to 12.4) favours delayed removal. However, because the 95% CI includes zero and the upper CI exceeds the predefined limit for non-inferiority (8%), non-inferiority was not demonstrated. The rates of all secondary outcomes were similar in the early group and the delayed group: seroma/hematoma (6.9% vs. 4.7%; RR 1.4, 95% CI 0.6 to 3.7, P = 0.4); surgical site infection (9.7% vs. 4.8%; RR 2.0, 95% CI 0.8 to 4.9, P = 0.1); and composite (superficial wound dehiscence, seroma/hematoma, and surgical site infection) wound complication (17.2% vs. 12.8%; RR 1.3, 95% CI 0.8 to 2.3, P = 0.3).
  
  
  CONCLUSIONS
  The non-inferiority of early skin staple removal was not demonstrated. Delayed removal of staples should remain the accepted standard in the obese patient following Caesarean section.
authors.affiliation: Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Greenville Hospital System University Medical Center, University of South Carolina School of Medicine, Greenville SC.
authors.forename: Francis S
authors.initials: FS
authors.lastname: Nuthalapaty
authors.affiliation: Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Greenville Hospital System University Medical Center, University of South Carolina School of Medicine, Greenville SC.
authors.forename: Christy M
authors.initials: CM
authors.lastname: Lee
authors.affiliation: Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Greenville Hospital System University Medical Center, University of South Carolina School of Medicine, Greenville SC.
authors.forename: Jill H
authors.initials: JH
authors.lastname: Lee
authors.affiliation: Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Greenville Hospital System University Medical Center, University of South Carolina School of Medicine, Greenville SC.
authors.forename: Spencer G
authors.initials: SG
authors.lastname: Kuper
authors.affiliation: Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Greenville Hospital System University Medical Center, University of South Carolina School of Medicine, Greenville SC.
authors.forename: H Lee
authors.initials: HL
authors.lastname: Higdon
mesh_terms: D000328:Adult; D002585:Cesarean Section; D020878:Device Removal / Q000009:adverse effects*; D005260:Female; D006406:Hematoma / Q000209:etiology; D006801:Humans; D009765:Obesity / Q000150:complications*; D010149:Postoperative Pain / Q000209:etiology; D049291:Seroma / Q000209:etiology; D017792:Surgical Stapling; D013529:Surgical Wound Dehiscence / Q000209:etiology*; D013530:Surgical Wound Infection / Q000209:etiology; D013537:Sutures / Q000009:adverse effects*; D013997:Time Factors; D055815:Young Adult
keywords: Caesarean section; obesity; skin closure; staples; surgical site infection; wound complications