Prospective Study on Cesarean Wound Outcomes

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Argentum Medical LLC
Sponsor:
Information provided by (Responsible Party):
Argentum Medical LLC
ClinicalTrials.gov Identifier:
NCT01927211
First received: August 20, 2013
Last updated: NA
Last verified: August 2013
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]
  • Surgical site infection [ Time Frame: Six weeks post-operative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cosmetic appearance [ Time Frame: Seven days post-operative ] [ Designated as safety issue: No ]
  • Cosmetic appearance [ Time Frame: Six weeks post-operative ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Pain [ Time Frame: Seven days post-operative ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: Six weeks post-operative ] [ Designated as safety issue: No ]

Estimated Enrollment: 660
Study Start Date: July 2013
Estimated Primary Completion Date: January 2015 (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

Ages Eligible for Study:   18 Years and older
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
USF Health, South Tampa Center for Advanced Healthcare Recruiting
Tampa, Florida, United States, 33606
Tampa General Hospital, Women's Center, Labor and Delivery Recruiting
Tampa, Florida, United States, 33606
USF Health, Morsani Center for Advanced Healthcare Active, not recruiting
Tampa, Florida, United States, 33612
Tampa General Hospital, Genesis At HealthPark Recruiting
Tampa, Florida, United States, 33610
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:

Responsible Party: Argentum Medical LLC
ClinicalTrials.gov Identifier: NCT01927211     History of Changes
Obsolete Identifiers: NCT01697748
Other Study ID Numbers: USF Csection Study
Study First Received: August 20, 2013
Last Updated: August 20, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Infection
Communicable Diseases
Pain, Postoperative
Wound Infection
Surgical Wound Infection
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Wounds and Injuries

ClinicalTrials.gov processed this record on September 22, 2014