Clinical trial NCT01198691: A Comparison of Metallic Staples Versus Absorbable Staples After a Cesarean Section (C-Section)
Official title: Closure of Pfannenstiel Skin Incisions After Cesarean Delivery: A Comparison of Metallic Staples Versus Absorbable Staples
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cesarean Section
Keywords: metallic staples
absorbable staples
Cesarean Delivery
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2010-09-10
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Post Operative Pain
timeFrame: 1 Year
measure: Post Operative Pain (3 Days Post-op)
timeFrame: 1 Year
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: This will be assessed 3 day after the patient's C-section before they are discharged from the hospital
measure: Patient Satisfaction
timeFrame: Patient satisfaction will be assessed 6 weeks later at their post-op visit
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
Study officials:
References:
citation: Feese CA, Johnson S, Jones E, Lambers DS. A randomized trial comparing metallic and absorbable staples for closure of a Pfannenstiel incision for cesarean delivery. Am J Obstet Gynecol. 2013 Dec;209(6):556.e1-5. doi: 10.1016/j.ajog.2013.08.001. Epub 2013 Aug 3.