Cesarean Trial of Staples vs. Sutures

Not Applicable

Completed

Conditions: Wound Complications
Patient Satisfaction
Cesarean Section
Pain Measurement

Interventions: Other: Staples
Other: Suture

Registration Number: NCT01211600

Lead Sponsor: Thomas Jefferson University

Brief Summary: To determine whether the rate of wound complications differs based on method of closure of skin incision (staples vs. suture) after cesarean delivery.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 746

Inclusion Criteria

Women undergoing cesarean delivery for pregnancy greater than 23 weeks gestation.

Exclusion Criteria

Poorly controlled diabetes (defined as ≥ 50% of fasting or 2 hour postprandial glucose levels > 95 and 120 respectively within the week prior to delivery),
Vertical skin incisions
Chronic steroid use
Active lupus flare
HIV/AIDS
Current treatment for cancer or a history of radiation to the abdomen/pelvis
Current treatment with immunosuppressant medications secondary to history of transplantation
Emergency cesarean(precluding informed consent prior to surgery)
Lack of access to a phone
Allergy to suture or staple material

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Staples	Staples	Interrupted Ethicon Staples
Suture	Suture	Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)

Primary Outcome Measures

Name	Time	Method
Number of Participants With Wound Complications	Within 6 weeks of postpartum	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.

Secondary Outcome Measures

Name	Time	Method
Patient Scar Assessment Scale Scores for Evaluation of Cosmesis	Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks.	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.
Patient Satisfaction With Closure Method and Scar Appearance	Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks.	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.
Pain Perception	Immediately postpartum to time of discharge, which is typically 3-4 days post-cesarean	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.
Additional Provider Visits	Within 6 weeks postpartum	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).
Number of Participants With Primary Versus Repeat Cesarean	At randomization.	Randomization stratum - BMI (over/under 30) and Cesarean (primary or repeat)
Intraoperative Trial Details - Duration of Operation and Skin Closure	Time of Cesarean	Duration of operation: skin incision to skin closure Duration of skin closure: fascial closure to skin closure
Intraoperative Trial Details - Closure of Subcutaneous Tissue	Time of Cesarean	Number of participants requiring subcutaneous tissue closure
Length of Hospital Stay	Immediate postpartum.	Length of hospital stay (days)
Number of Participants That Received Anticoagulation Within 24 Hours	Within 24 hours postpartum.	Number of participants that received anticoagulation within 24 hours of procedure (preoperatively or postoperatively)
Number of Participants Diagnosed With Endomyometritis	Immediate postpartum.	Number of participants diagnosed with endomyometritis requiring antibiotics
Change in Hemoglobin Pre-operatively to Post-operatively	Up to 72 hours before and 24 hours after cesarean.	Median change in hemoglobin from preoperative value (g/dL) to post-operatively.
Observer Evaluation of Cosmesis of the Cesarean Incision Based on Closure Method: Staples vs Sutures.	Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks.	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.

Trial Locations

Locations (2): Yale University
🇺🇸
New Haven, Connecticut, United States
Thomas Jefferson University Hospital
🇺🇸
Philadelphia, Pennsylvania, United States