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Prospective Study on Cesarean Wound Outcomes

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2015 by Argentum Medical LLC.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01927211
First Posted: August 22, 2013
Last Update Posted: December 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Argentum Medical LLC
  Purpose

The study will investigate whether the placement of silver plated dressings beginning in the OR will improve wound healing in patients undergoing cesarean delivery compared to traditional Telfa pads. This study will also explore the presumed improvement in scar integrity when silver plated dressings are used compared to Telfa pads. The study will examine post-operative pain by review of anesthesia and analgesic use during hospitalization and scar-related pain scores at the post-operative visits.

The study will compare the percentage of patients who develop a surgical site infection after application of silver plated dressings versus standard Telfa dressings. Investigators will also assess the cosmetic appearance of the cesarean section scar at the patient's one week and 6 wekk post-operative visits.


Condition Intervention
Surgical Site Infection Cosmetic Appearance of Cesarean Scar Post-operative Pain Device: Silver Plated dressing Device: Telfa pad dressing

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Prospective Randomized Study Assessing Post Operative Wound Infections Along With Cosmetic Outcomes Using Silver Plated Dressings Compared to Conventional Dressings on Cesarean Section Incisions

Resource links provided by NLM:


Further study details as provided by Argentum Medical LLC:

Primary Outcome Measures:
  • Surgical site infection [ Time Frame: Seven days postoperative ]
  • Surgical site infection [ Time Frame: Six weeks post-operative ]

Secondary Outcome Measures:
  • Cosmetic appearance [ Time Frame: Seven days post-operative ]
  • Cosmetic appearance [ Time Frame: Six weeks post-operative ]

Other Outcome Measures:
  • Pain [ Time Frame: Seven days post-operative ]
  • Pain [ Time Frame: Six weeks post-operative ]

Estimated Enrollment: 660
Study Start Date: July 2013
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Telfa pad dressing
Telfa pad dressing placed over Cesarean wound after skin closure, the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7.
Device: Telfa pad dressing
Telfa pad dressing placed over Cesarean wound after skin closure, the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7
Other Name: Telfa pad
Active Comparator: Silver Plated Dressing
Silver plated dressing placed over Cesarean wound after skin closure, the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7
Device: Silver Plated dressing
Silver plated dressing placed over Cesarean wound after skin closure, the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7
Other Name: Silverlon

Detailed Description:

This is a randomized, prospective study involving 660 patients undergoing cesarean sections at Tampa General Hospital. The control group (n=330) will receive standard Telfa pad dressing and the treatment group (n=330) will receive the silver plated dressing.

The primary objective is to compare the percentage of patients who develop a surgical site infection between the two groups at 1-week and 6-weeks post operative visits. The secondary objective is to assess the cosmetic outcome of the cesarean incision observed at the 1-week and 6-week post-operative visits. A panel of plastic surgeons will conduct a blinded assessment of cosmetic outcome by review of photographs taken of the wounds at 1-week and 6-weeks. Finally, this study will examine post-operative pain by review of anesthesia and analgesic use during hospitalization and scar-related pain scores at the post-operative visits.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 or older
  • Elective and emergent cesarean deliveries
  • Primary and repeat cesarean section
  • Transverse skin incisions (Pfannenstiel)
  • Low transverse uterine incision
  • Patients with or without the diagnosis of chorioamnionitis with antibiotic treatment prior to or after the delivery of the baby
  • Single and multiple gestations
  • Willing and able to provide written informed consent

Exclusion Criteria:

  • Patients that did not receive routine prophylactic dose of antibiotics in the operating room.
  • Skin incisions other than Pfannenstiel
  • Uterine incisions other than low transverse
  • Patients with known or discovered allergy to silver or nylon
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01927211


Contacts
Contact: Melissa Cardenas, BS 813-259-8680 obgynclinicalresearch@health.usf.edu
Contact: Caroline Young, MSN, ARNP 813-259-8680 obgynclinicalresearch@health.usf.edu

Locations
United States, Florida
Tampa General Hospital, Women's Center, Labor and Delivery Recruiting
Tampa, Florida, United States, 33606
USF Health, South Tampa Center for Advanced Healthcare Recruiting
Tampa, Florida, United States, 33606
Tampa General Hospital, Genesis At HealthPark Recruiting
Tampa, Florida, United States, 33610
USF Health, Morsani Center for Advanced Healthcare Active, not recruiting
Tampa, Florida, United States, 33612
Sponsors and Collaborators
Argentum Medical LLC
Investigators
Principal Investigator: Sheila Connery, MD USF Morsani College of Medicine, Department of Obstetrics and Gynecology
  More Information

Publications:
Perkins James, Pattillo Rolandid. How to Avert Postoperative Wound Complications -Treat It when It Occurs. OBG Management 2009;21(10):43-53.
Thomas Steve. MRSA and the Use of Silver Dressings: Overcoming Bacterial Resistance. http://www.worldwidewounds.com/2004/november/Thomas/Introducing- Silver Dressings.html.
10.Reducing Surgical Sites Infections: Http://www.infectioncontroltoday.com/articles/2008/03/reducing-surgical-site-infections.aspx, March 1, 2008.
. Clinical features and diagnosis of allergic contact dermatitis.http://www.uptodate.com /contents/clinical-features-and-diagnosis-of-allergic-contact dermatitis?source=search _result&search=clinical+features+and+diagnosis+of+allergic+contact&selectedTitle=2%7E150

Responsible Party: Argentum Medical LLC
ClinicalTrials.gov Identifier: NCT01927211     History of Changes
Obsolete Identifiers: NCT01697748
Other Study ID Numbers: USF Csection Study
First Submitted: August 20, 2013
First Posted: August 22, 2013
Last Update Posted: December 30, 2015
Last Verified: December 2015

Keywords provided by Argentum Medical LLC:
cesarean section incisions
silver
C-section
wound infection
scar appearance
pain

Additional relevant MeSH terms:
Infection
Pain, Postoperative
Surgical Wound Infection
Wound Infection
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms