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

TriHealth

Status and phase: Completed; Phase 2

Conditions: Cesarean Section

Treatments: Device: Insorb absorbable staples; Device: Insorb

Study type: Interventional

Funder types: Other

Identifiers

NCT01198691

10018-10-016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

• History of drug or alcohol abuse
• Contraindication to post operative NSAID's or Narcotics
• Emergent Cesarean Deliveries
• Less then 18 years of age

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups, including a placebo group

Control Group

Placebo Comparator group

Description:

This group will receive the standard metallic staples to close their incision.

Treatment:

Device: Insorb absorbable staples

Case Group

Experimental group

Description:

This group will receive the Insorb absorbable staples to close their incision.

Treatment:

Device: Insorb