Participants

The cohort for this study comprised women presenting to Good Samaritan Hospital for a scheduled cesarean delivery via Pfannenstiel skin incision, and who met all of the following inclusion criteria: (1) singleton gestation; (2) ≥18 years of age; and (3) obtained prenatal care through the Good Samaritan Hospital Obstetrics/Gynecology Resident Clinic or the maternal-fetal medicine attending private practice. Excluded from the study were those patients with a history of drug or alcohol abuse, contraindications to postoperative nonsteroidal antiinflammatory drugs or narcotics, and undergoing emergent cesarean delivery. Patients were recruited from July 2010 through May 2011. The Figure reveals the patient flowchart from enrollment to analysis.

Flowchart of patients from enrollment to analysis

VAS , visual analog scale.

Feese. Staple skin closure at cesarean delivery. Am J Obstet Gynecol 2013 .

Interventions

All patients provided informed consent, and were randomized, via sealed envelopes, using a random number generator. The control group received metallic staples using a Proximate PXW35 Skin Stapler (Ethicon Endo-Surgery Inc, Cincinnati, OH) and the experimental group received subcuticular absorbable polylactic/polyglycolic acid staples using a Food and Drug Administration–approved sterile, single-patient-use stapling device. All patients received antibiotics preoperatively within 60 minutes of skin incision. The nursing staff and the patient were blinded to the type of skin closure throughout the postoperative period, and both groups of patients received identical dressings that remained in place until the day of discharge. Prior to using the device, the resident physicians and faculty received an in-service from the company representative on how to place the absorbable sutures.

All data were extracted by the primary investigator from the patients’ electronic medical records in OB Trace View (Phillips, Andover, MA). Prenatal records and surveys were obtained either from the Good Samaritan Hospital Obstetrics/Gynecology Resident Clinic or the maternal-fetal medicine attending private practice.

Objectives

The primary outcome was pain on postoperative day 1, and on the day of discharge. This was determined by the use of a visual analog scale (VAS) score and the total number and dose of narcotic pills taken by the patient during hospitalization. The VAS score was recorded in the medical record by the postpartum nurse during routine assessments of the patient’s incisional pain on postoperative day 1, and on the day of discharge. The total number and type of oral narcotics taken during the postoperative period was determined from the patients’ medical records. Ibuprofen is a self-medication available at the bedside, and therefore, was not counted. All patients were instructed to take 800 mg every 6 hours. The charts were reviewed for any evidence of wound complications, defined as a seroma, cellulitis, hematoma, dehiscence, and wound disruptions. In addition, patients were asked if they were treated for a wound complication on the 6-week postpartum patient survey.

Secondary outcomes included time of skin closure, patient satisfaction, and cost. Time of skin closure was recorded by the circulating nurse, using the clock in the operating room in total seconds, and entered into the patient’s medical record. Patient satisfaction was evaluated by a survey that was administered on the day of discharge after the patient’s dressing was removed, but before staple removal, if needed, as well as at the 6-week postpartum visit. Cost was calculated by assessing the cost of the 2 stapling devices used per surgery, operating room costs of $70.00 per 1-minute increments applied to the differences in the times of skin closure between the 2 methods, and the additional costs of staple removal device and registered nurse time for the metallic staples removal ( Current Procedural Terminology code 99211).

After conducting a power calculation for a 2-group t test with a .050 2-sided significance level, 50 patients were included in each group to have a 90% power to detect the difference of 2.68 in the VAS score. For independent samples, t test was used for analyses involving continuous variables, including difference in postoperative pain between the 2 groups. The χ ² (or Fisher exact test where appropriate) was used for analyses involving categorical variables. Software (SPSS, version 19; IBM Corp, Armonk, NY) was used for all analyses.