A Comparison of Metallic Staples Versus Absorbable Staples After a Cesarean Section (C-Section)

Phase 2

Completed

Brief Summary: The purpose of the study is to compare post operative pain, cost effectiveness, speed of closure and patient satisfaction of Pfannenstiel incisions closed with metallic staples versus absorbable staples (Insorb) after Cesarean Delivery.

Detailed Description: The ideal method of closing the skin following a Pfannenstiel incision has not yet been established. Presently, the method of skin closure is a matter of the surgeon's personal preference. Currently, there is limited evidence regarding which method is considered "superior" in terms of post operative pain, patient satisfaction, and cost effectiveness. This information would be incredibly valuable in helping guide surgeons in their choice of skin closure technique; and with the rates of Cesarean deliveries rapidly rising, it is important to determine the best method of skin closure in order to optimize patient care.

After a patient is consented she will be randomized into either the control group and receive the standard metallic staples or the experimental group and receive the absorbable staples for her skin closure procedure. One day after her procedure the RN will ask the patient to rate her pain using a 10cm VAS pain scale. Two or three days after the skin closure and before the patient is discharged a short survey about the patient's satisfaction of her scar appearance will be administered. The PI will go back and review the patient's chart to determine the amount of narcotics administered.

Recruitment & Eligibility

Inclusion Criteria

Obstetric service patients (receiving prenatal care from the Faculty Medical Center)
Women greater than 18 years old
Singleton gestation
Cesarean Section performed by Pfannenstiel skin incision

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Case Group	Insorb	This group will receive the Insorb absorbable staples to close their incision.
Control Group	Insorb absorbable staples	This group will receive the standard metallic staples to close their incision.

Primary Outcome Measures

Name	Time	Method
Post Operative Pain (3 Days Post-op)	1 Year	Post operative pain at the time of discharge will be measured using the Visual Analogue Scale (VAS). The scale has a minimum score of 0 representing no pain and a maximum score of 10 representing the worst possible pain.
Post Operative Pain	1 Year	Post operative pain at post operative day #1 will be measured using the Visual Analogue Scale (VAS). The scale has a minimum score of 0 representing no pain and a maximum score of 10 representing the worst possible pain.

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction	Patient satisfaction will be assessed 6 weeks later at their post-op visit	Patients will be given a survey at their 6 week post-op visit to assess their satisfaction with the appearance of their scar. The survey asked whether patients "strongly agree," "agree," "disagree," or "strongly disagree" with the statement, "I am satisfied with the overall appearance of my incision." Those who responsed "agree" or "strongly agree" were said to be satisfied with the appearance and the outcome is reported as number of participants who were satisfied.