Impact of Timing of Wound Dressing Removal After Cesarean Section

November 6, 2020 updated by: The University of Texas Medical Branch, Galveston

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

The purpose of this study is to assess wound healing at 24 vs 48 hours post cesarean delivery with a modified 1-day ASEPSIS score.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 postoperative 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 stays in place for 24-48 hours postoperatively on an incision that has been closed by primary intention. Although the window of the 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 compared the impact of dressing removal at 24 vs 48 hours on wounds following low-risk cesarean deliveries. While epithelial proliferation begins within hours of closure, it is not at its maximum until 48 to 72 hours following injury. The current standard of care is to keep the dressing in place 24 to 48 hours postoperatively. 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 postoperatively by evaluating its impact on wound appearance and wound score 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 in 5 days postoperatively. The 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. For practical reasons, absolute scores were obtained based on a 1-day reading in our study, rather than the 5-day reading used in the original ASEPSIS scoring system. Another objective of this study is to evaluate patients' satisfaction according to complaints about their incision. Pain, erythema, induration, separation of skin, and serous or purulent exudates will be documented.

Study Type

Interventional

Enrollment (Actual)

869

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06010
        • Etlik Zübeyde Hanim Women's Health Training and Research Hospital
      • Diyarbakır, Turkey, 21280
        • Dicle University
  • United States
    • Texas
      • Galveston, Texas, United States, 77550
        • University of Texas Medical Branch at Galveston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 44 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • low-risk obstetric patients aged 18-44 years with term, singleton pregnancies who planned to have Cesarean Delivery (CD).

CD indications:

  1. Scheduled nonlabored primary CD for fetal malpresentation,
  2. Suspected macrosomia,
  3. Maternal request,
  4. Placental anomaly,
  5. Abnormal / indeterminate fetal heart tracing without labor.
  6. First, second, and third repeat CDs will be included.

Exclusion Criteria:

  1. Preeclampsia,
  2. Preeclampsia with severe features,
  3. Eclampsia,
  4. Known preoperative infectious disease, any unknown origin preoperative fever,
  5. Diabetes,
  6. Pregnant with premature rupture of membrane (PROM) or rupture of membrane (ROM),
  7. Intraoperative findings suggestive of an underlying cancerous condition,
  8. Vertical skin incision,
  9. Planned hysterectomy during CD.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ASEPSIS Wound Score (1-day)
Time Frame: 24 or 48 Hours Postoperative
24 or 48 Hours Postoperative

Secondary Outcome Measures

Outcome Measure
Time Frame
ASEPSIS Wound Score (1-day)
Time Frame: 1 Week Follow-Up
1 Week Follow-Up
ASEPSIS Wound Score (1-day)
Time Frame: 6 Week Follow-Up
6 Week Follow-Up

Other Outcome Measures

Outcome Measure
Time Frame
Patients' satisfaction
Time Frame: 24 or 48 Hours Postoperative
24 or 48 Hours Postoperative
Patients' satisfaction
Time Frame: 1 Week Follow-Up
1 Week Follow-Up
Patients' satisfaction
Time Frame: 6 Week Follow-Up
6 Week Follow-Up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Medical Branch, Galveston

Collaborators

Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
Dicle University

Investigators

  • Principal Investigator: Gokhan S Kilic, MD, University of Texas Medical Branch at Galveston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2015

Primary Completion (ACTUAL)

February 1, 2017

Study Completion (ACTUAL)

January 31, 2019

Study Registration Dates

First Submitted

May 12, 2015

First Submitted That Met QC Criteria

May 12, 2015

First Posted (ESTIMATE)

May 15, 2015

Study Record Updates

Last Update Posted (ACTUAL)

November 10, 2020

Last Update Submitted That Met QC Criteria

November 6, 2020

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-0548

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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