NCT01198691

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

Closure of Pfannenstiel Skin Incisions After Cesarean Delivery: A Comparison of Metallic Staples Versus Absorbable Staples

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: TriHealth Inc. · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cesarean Section

Interventions

Type	Name	Description
DEVICE	Insorb absorbable staples	Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples
DEVICE	Insorb	Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples

Timeline

• Start date: 2010-07-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2010-09-10
• Last updated: 2018-10-09
• Results posted: 2014-06-12

Locations

1 site across 1 country: United States