Clinical trial NCT02445729: Impact of Timing of Wound Dressing Removal After Cesarean Section
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Wall Wound
Keywords: Cesarean Section
Wound Healing
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
Collaborators: name: Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
name: Dicle University
First posted: 2015-05-15
Enrollment: 869
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: ASEPSIS Wound Score (1-day)
timeFrame: 24 or 48 Hours Postoperative
Secondary outcomes:
measure: ASEPSIS Wound Score (1-day)
timeFrame: 1 Week Follow-Up
measure: ASEPSIS Wound Score (1-day)
timeFrame: 6 Week Follow-Up
Other outcomes:
measure: Patients' satisfaction
timeFrame: 24 or 48 Hours Postoperative
measure: Patients' satisfaction
timeFrame: 1 Week Follow-Up
measure: Patients' satisfaction
timeFrame: 6 Week Follow-Up
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch at Galveston
state: Texas
city: Ankara
country: Turkey
facility: Etlik Zübeyde Hanim Women's Health Training and Research Hospital
city: Diyarbakır
country: Turkey
facility: Dicle University
Study officials:
affiliation: University of Texas Medical Branch at Galveston
name: Gokhan S Kilic, MD
role: PRINCIPAL_INVESTIGATOR
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