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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cesarean Section

Intervention / Treatment
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* Device: Insorb absorbable staples
* Device: Insorb


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control Group<br>This group will receive the standard metallic staples to close their incision. | Device: Insorb absorbable staples<br>* Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples<br>|
| Experimental: Case Group<br>This group will receive the Insorb absorbable staples to close their incision. | Device: Insorb<br>* Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Operative Pain | 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. | 1 Year | 
| Post Operative Pain (3 Days Post-op) | 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. | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction | Patients will be given a survey prior to being discharged 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. | This will be assessed 3 day after the patient's C-section before they are discharged from the hospital | 
| Patient Satisfaction | 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. | Patient satisfaction will be assessed 6 weeks later at their post-op visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metallic staples, absorbable staples, Cesarean Delivery