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

NCT01198691 | Completed Phase 2 Results

• 1 other identifier: 10018-10-016
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Section

Keywords

metallic staples; absorbable staples; Cesarean Delivery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Patient Satisfaction

  This will be assessed 3 day after the patient's C-section before they are discharged from the hospital

• Patient Satisfaction

  Patient satisfaction will be assessed 6 weeks later at their post-op visit

Study Arms (2)

Control Group

PLACEBO COMPARATOR

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

Device: Insorb absorbable staples

Case Group

EXPERIMENTAL

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

Device: Insorb

Interventions

Insorb absorbable staples DEVICE

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

Control Group

Insorb DEVICE

Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples

Case Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• TriHealth Inc.: lead

Study Sites (1)

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

Location

Related 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 Aug 3.

  PMID: 23921089 RESULT

Limitations and Caveats

Low response rate to patient surveys at discharge and at 6 weeks postpartum.

Results Point of Contact

• Title: Donna Lambers, MD
• Organization: TriHealth

donna_lambers@trihealth.com

513-862-2828

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2010
• First Posted: September 10, 2010
• Study Start: July 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: October 9, 2018
• Results First Posted: June 12, 2014

Record last verified: 2014-05

Locations

US (1)