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

Cesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01198691
• Other study ID #: 10018-10-016
• Status: Completed
• Phase: Phase 2
• Start date: July 2010
• Est. completion date: May 2011

Study information

• Verified date: May 2014
• Source: TriHealth Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

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:

• History of drug or alcohol abuse

• Contraindication to post operative NSAID's or Narcotics

• Emergent Cesarean Deliveries

• Less then 18 years of age

Related Conditions & MeSH terms

• Cesarean Section

Intervention

Device:
• Insorb absorbable staples
Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples
• Insorb
Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples

Locations

Country	Name	City	State
United States	Good Samaritan Hospital	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
TriHealth Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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