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Impact of Timing of Wound Dressing Removal After Cesarean Section

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ClinicalTrials.gov Identifier: NCT02445729
Recruitment Status : Unknown
Verified May 2016 by The University of Texas Medical Branch, Galveston.
Recruitment status was:  Enrolling by invitation
First Posted : May 15, 2015
Last Update Posted : January 13, 2017
Sponsor:
Collaborators:
Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
Dicle University
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

Brief Summary:
The purpose of this study is to determine if surgical dressings removed at 24 hours or 48 hours improves wound healing and appearance, and to determine if surgical dressings removed after 24 hours or 48 hours decreases the incidence of post-operative wound infections.

Condition or disease Intervention/treatment Phase
Abdominal Wall Wound Other: Dressing removal at 24 hours Other: Dressing removal at 48 hours Not Applicable

Detailed Description:

Immediate wound coverage is one of the cornerstones of post-operative wound management. Dressings are typically left in place for 24 to 48 hours following cesarean section to allow ample time for healing and re-epithelialization. The functions of a surgical dressing for wound healing by primary intention are to control postoperative bleeding, absorb exudate, ease pain, and provide protection for newly-formed epithelium. The skin is an important anatomical barrier against microbes; the reformation of an intact epithelial system following injury is an important milestone for the prevention of infection.

Wound healing is a dynamic process that involves the coordinated interaction of a variety of cells, including cytokines, blood cells, extracellular matrix proteins, and parenchyma cells. Wound healing has been artificially divided into three phases: inflammation, tissue formation (proliferation), and tissue remodeling. These phases do not correspond to a precise period of time following injury, and all of the phases overlap to some degree. Re-epithelialization occurs during the proliferation phase and it is defined as the process of restoring an intact epidermis after injury. It involves several processes, including the migration and proliferation of adjacent epidermal keratinocytes into the wound, the differentiation of the neo-epithelium into a stratified epidermis, and the restoration of an intact basement membrane zone (BMZ) that will connect the epidermis and the underlying dermis. Re-epithelialization of wounds begins within hours after injury. Within 24 hours, keratinocytes are actively proliferating from the margins of the wound to cover the defect.

Surgical wounds that are closed by primary intention usually heal rapidly, and re-epithelialization is thought to occur within 24 to 48 hours. Early studies into wound care demonstrated that dressings influence the repair process. The post-operative wound dressing acts to ensure the wound bed stays moist, decrease pain and inflammation, and improve scar appearance. Additionally, occlusive dressings increase the rate of re-epithelialization post-operatively compared to those wounds left open. The importance of dressings has been established, but the ideal time that postoperative dressings should remain in place remains elusive. Studies have shown that early removal of dressings (6 hours after wounding) markedly decreases the rate of resurfacing, while leaving the bandage on for greater than 48 hours produced no greater benefit. The United States Centers for Disease Control and Prevention recommends that the sterile dressing stay in place for 24-48 hours post-operatively on an incision that has been closed by primary intention. Although the window of benefit provided by bandages has not been further refined since these earlier studies. By defining the period during which dressings will promote epithelial resurfacing, our ability to use the dressing optimally will be enhanced.

Our goal of this study is to investigate if there is a difference in outcomes in dressings that are left in place for 24 hours versus 48 hours. While epithelial proliferation begins within hours of closure, it is not at its maximum until 48 to 72 hours following injury. Current standard of care is to keep the dressing in place 24 to 48 hours post-operatively. However, there is no data comparing the optimum timing between 24 and 48 hours. We will therefore assess the benefit of leaving the dressing in place for 24 vs 48 hours post-operatively by evaluating its impact on wound appearance and incidence of surgical site infections using the ASEPSIS scoring method.

The ASEPSIS is a quantitative scoring method that provides a numerical score related to the severity of wound infection using objective criteria based on wound appearance and the clinical consequences of the infection. Severity of impaired wound healing is indicated by the total score as follows: satisfactory healing 0 to 10; disturbance of healing 11 to 20; minor wound infection 21 to 30; moderate wound infection 31 to 40; and severe wound infection more than 40.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 860 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Impact of Timing of Wound Dressing Removal After Cesarean Section: Effect of Dressing Removal at 24 Hours Versus 48 Hours on Wound Healing and Incidence of Surgical Site Infections Following Cesarean Section
Study Start Date : March 2015
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Dressing Removal at 24 Hours
These patients are randomly assigned to have their dressing removed 24 hours after cesarean section.
Other: Dressing removal at 24 hours
Dressing will be removed 24 hours after cesarean section and wounds will be assessed for healing and presence of infection.

Active Comparator: Dressing Removal at 48 Hours
These patients are randomly assigned to have their dressing removed 48 hours after cesarean section.
Other: Dressing removal at 48 hours
Dressing will be removed 48 hours after cesarean section and wounds will be assessed for healing and presence of infection.




Primary Outcome Measures :
  1. ASEPSIS Wound Score [ Time Frame: 24 or 48 Hours Postoperative ]

Secondary Outcome Measures :
  1. ASEPSIS Wound Score [ Time Frame: 1 Week Follow-Up ]
  2. ASEPSIS Wound Score [ Time Frame: 2 Week Follow-Up ]
  3. ASEPSIS Wound Score [ Time Frame: 6 Week Follow-Up ]

Other Outcome Measures:
  1. Wound Characteristic Score [ Time Frame: 24 or 48 Hours Postoperative ]
  2. Wound Characteristic Score [ Time Frame: 1 Week Follow-Up ]
  3. Wound Characteristic Score [ Time Frame: 2 Week Follow-Up ]
  4. Wound Characteristic Score [ Time Frame: 6 Week Follow-Up ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant Patients between the ages of 18-50 planning to undergo cesarean section for delivery.

Exclusion Criteria:

  • Intra-operative findings suggestive of underlying cancerous condition
  • Known preoperative infectious disease.
  • Hysterectomy during cesarean section.

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): NCT02445729


Locations
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United States, Texas
University of Texas Medical Branch at Galveston
Galveston, Texas, United States, 77550
Turkey
Etlik Zübeyde Hanim Women's Health Training and Research Hospital
Ankara, Turkey, 06010
Dicle University
Diyarbakır, Turkey, 21280
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
Dicle University
Investigators
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Principal Investigator: Gokhan S Kilic, MD University of Texas Medical Branch at Galveston

Publications:

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Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT02445729     History of Changes
Other Study ID Numbers: 14-0548
First Posted: May 15, 2015    Key Record Dates
Last Update Posted: January 13, 2017
Last Verified: May 2016
Keywords provided by The University of Texas Medical Branch, Galveston:
Cesarean Section
Wound Healing
Additional relevant MeSH terms:
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Wounds and Injuries