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NCT Number: NCT01697748

Prospective Study on Cesarean Wound Outcomes

This study will investigate whether the placement of silver impregnated 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 impregnated dressings are used compared to the Telfa pads.

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

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Key information

Conditions

Surgical Site Infection Cosmetic Appearance of Cesarean Scar Infections Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Post Operative Pain Postoperative Complications Signs and Symptoms Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

USF Health Morsani Center for Advanced Healthcare, Tampa, Florida, United States

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About this study

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 impregnated dressing.

The primary objective is to compare the percentage of patients who develop a surgical site infection between the two groups at the 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 plastic surgery investigator will also conduct a blinded assessment of cosmetic outcome by review of photographs taken of the wounds at 1-week and 6-weeks.The tertiary objective is to evaluate the amount of narcotic and non narcotic medicine consumed during the hospitalization and query the patient with regards to pain involving the cesarean wound at 1 and 6 week post-operative visits

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 or older
  • Elective and emergent cesarean deliveries
  • Primary and repeat cesarean sections
  • Transverse skin incisions (Pfannenstiel)
  • Low transverse uterine incisions
  • Patients with or without the diagnosis of chorioamnionitis with antibiotic treatment prior to or after the delivery of the baby
  • Single and multiple gestations
  • Able and willing 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

Treatment and study plan

Silver-Impregnated Dressing

Device

Silver-impregnated 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 names: Silverlon

Telfa pad dressing

Device

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 names: Telfa pad

Primary outcomes

  1. Percentage of Patients Who Develop a Surgical Site Infection

    Time frame: from post operative day #1 through post operative day 30

    A surgical site infection involving the skin and subcutaneous tissue is defined as either

    • The presence of a purulent discharge from the wound on inspection, or
    • Purulent discharge obtained from the wound after exploration based on the suspicion of the provider (erythema, swelling, heat or pain), or
    • The presence of a seroma or hematoma discharge from the wound on inspection or after exploration that also involves isolation of an organism from an aseptically obtained culture based on suspicion of the provider (erythema, swelling, heat or pain). Seromas or hematomas with negative cultures will not be considered a surgical site infection.

Secondary outcomes

  1. Cosmetic Outcome of the Cesarean Section Incision

    Time frame: Post operative day 7

    The following instruments will be used to determine the cosmetic outcome:

    • The Modified Vancouver scar scale Range of scale values are from 0-12 (0 indicating a better outcome)

  2. Cosmetic Outcome of the Cesarean Section Incision

    Time frame: Six weeks post-operative

    The following instruments will be used to determine the cosmetic outcome

    • The Modified Observer Scar Assessment Scale Range of scale values is from 5 - 50 ( the lower the score the better the outcome)

Other outcomes

  1. Reduction of Pain After Cesarean Delivery

    Time frame: Immediately post operatively to hospital discharge

    The amount of narcotics measured in Morphine equivalent milligrams and non opioids administered during the cesarean delivery hospitalization were recorded

  2. The Number of Participants Noting Pain at the One Week Post Cesarean Visit

    Time frame: Post operative day 7

    Pain response to notable pain at wound site during 7 day post operative visit Subjective self reporting pain as yes or no.

  3. The Number of Participants Noting Pain at the Six Weeks Post Cesarean Visit

    Time frame: 6 weeks post operative

    Pain response to notable pain at wound site during 6 week post operative visit Subjective self reporting of pain as yes or no.

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Registry information

Official study title

A Prospective Randomized Study Assessing Post Operative Wound Infections Along With Cosmetic Outcomes Using Silver Impregnated Dressings Compared to Conventional Dressings on Cesarean Section Incisions

Important dates

Study start
2013
Primary completion
2016
Study completion
2018
First posted
Oct 2, 2012
Registry last updated
Nov 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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