To determine whether the rate of wound complications differs based on method of closure of skin incision (staples vs. suture) after cesarean delivery.
Despite this large number of cesareans performed annually, there is a paucity of data to suggest which technique is superior for closure of the skin incision with regards to wound complications, including wound separation and infection. As the morbidity associated with a cesarean delivery is usually related to wound complications, especially infection, we feel that it is important to examine this outcome by comparing the current skin closure techniques: staples versus suture.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
746
Yale University
New Haven, Connecticut, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Number of Participants With Wound Complications
The primary outcome is to evaluate the rate of wound complications for patients undergoing cesarean whose skin incision is closed with staples versus with suture. Wound complications included infection, hematoma, seroma, and separation and readmission for wound complication.
Time frame: Within 6 weeks of postpartum
Patient Scar Assessment Scale Scores for Evaluation of Cosmesis
Patient evaluation of cosmesis of the cesarean incision based on closure method: staples vs sutures. Surgical scars were evaluated using Patient Scar Assessment Scale (PSAS). The PSAS evaluates six items: pain, itchiness, color, stiffness, thickness, and irregularity. Each item is scored on a 10-point scale comparing the patient's skin to normal skin, in which one represents normal skin. The score is summed, range 6-60. Lower scores indicate closer resemblance to normal skin and are superior.
Time frame: Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks.
Patient Satisfaction With Closure Method and Scar Appearance
Whether the patient's satisfaction with the incision differed based on closure method (staples vs sutures) using 10-point Likert scale on which 1 is completely dissatisfied and 10 is completely satisfied.
Time frame: Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks.
Pain Perception
Whether the patient's perception of pain associated with the incision differed based on closure method (staples vs sutures). Patients were asked to rate pain on a scale from 0 (no pain) to 10 (extreme pain) using a visual graph of facial expressions.
Time frame: Immediately postpartum to time of discharge, which is typically 3-4 days post-cesarean
Additional Provider Visits
Mean number of visits per participant (All wound visits, number of visits for women who were diagnosed with wound complications, number of visits for women who were not diagnosed with a wound complication).
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Time frame: Within 6 weeks postpartum
Number of Participants With Primary Versus Repeat Cesarean
Randomization stratum - BMI (over/under 30) and Cesarean (primary or repeat)
Time frame: At randomization.
Intraoperative Trial Details - Duration of Operation and Skin Closure
Duration of operation: skin incision to skin closure Duration of skin closure: fascial closure to skin closure
Time frame: Time of Cesarean
Intraoperative Trial Details - Closure of Subcutaneous Tissue
Number of participants requiring subcutaneous tissue closure
Time frame: Time of Cesarean
Length of Hospital Stay
Length of hospital stay (days)
Time frame: Immediate postpartum.
Number of Participants That Received Anticoagulation Within 24 Hours
Number of participants that received anticoagulation within 24 hours of procedure (preoperatively or postoperatively)
Time frame: Within 24 hours postpartum.
Number of Participants Diagnosed With Endomyometritis
Number of participants diagnosed with endomyometritis requiring antibiotics
Time frame: Immediate postpartum.
Change in Hemoglobin Pre-operatively to Post-operatively
Median change in hemoglobin from preoperative value (g/dL) to post-operatively.
Time frame: Up to 72 hours before and 24 hours after cesarean.
Observer Evaluation of Cosmesis of the Cesarean Incision Based on Closure Method: Staples vs Sutures.
Surgical scars were evaluated using Observer Scar Assessment Scale (OSAS). The OSAS evaluates five items: vascularity, pigmentation, thickness, relief, and pliability. Each item is scored on a 10-point scale comparing the patient's skin to normal skin, in which one represents normal skin. The score is summed, range 5-50. Lower scores indicate closer resemblance to normal skin and are superior.
Time frame: Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks.