Cesarian Scar, Surgical Site Infection (SSI)
Conditions
Keywords
cesarean section, wound dressing, polyurethane foam, scar formation, PSAS, korean women
Brief summary
Background: Cesarean delivery is one of the most frequently performed surgical procedures worldwide, and postoperative scar quality remains an important patient-centered outcome. Advanced dressings such as polyurethane foam are increasingly used to optimize the wound environment; however, evidence supporting their superiority over conventional gauze remains limited. This study aimed to compare the effects of polyurethane foam and gauze dressings on scar outcomes and surgical site infection (SSI) following cesarean delivery. Methods: In this prospective, single-blind randomized controlled trial conducted between 2024 and 2025, women undergoing cesarean delivery via Pfannenstiel incision were randomly assigned to receive either polyurethane foam or conventional gauze dressing. All procedures were performed by a single surgeon using a standardized 4-0 rapid Vicryl subcuticular closure technique. Scar outcomes were assessed using the Patient Scar Assessment Scale (PSAS) at 1 week, 1 month, and 6 months postoperatively. The incidence of 30-day SSI was also evaluated. Although there have been significant advancements in wound dressing materials and techniques, with numerous types of dressings now available, there has been a paucity of studies investigating the efficacy and scar outcomes of these modern dressings specifically in cesarean section, which is classified as a clean wound in obstetric and gynecological surgery. The present study, by incorporating patient scar satisfaction as an outcome measure, will serve as a valuable contribution to evaluating the clinical significance of contemporary wound dressings in this surgical context.
Interventions
DEVICEPolyurethane Foam dressing(Mepilex Border Flex)
Immediately after cesarean section, the wound was cleaned with alcohol and a Mepilex Border Flex polyurethane foam dressing was applied. On postoperative day 2, the wound was inspected; if no complications were found, a new Mepilex Border Flex dressing was applied. The wound was reassessed on postoperative day 4 prior to hospital discharge.
DEVICEConventional Gauze Dressing
Immediately after cesarean section, the wound was cleaned with alcohol and covered with a conventional sterile gauze dressing. On postoperative day 2, the gauze was removed for wound inspection and replaced with a new gauze dressing if the wound was clean. Patients were discharged on postoperative day 4.
Sponsors
Yewon Jung
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1\. Korean women aged 18 years or older who provided written informed consent to participate in the study 2\. Patients who underwent emergency or elective cesarean section 3\. Patients with a transverse skin and uterine incision (Pfannenstiel incision) 4\. Patients who received prophylactic antibiotics (Cefazolin 1g) intravenously 30 minutes prior to surgery 5\. Patients who completed at least three follow-up visits after discharge
Exclusion criteria
* Patients under 18 years of age 2\. Patients who did not undergo transverse skin or uterine incision (i.e., vertical incision) 3\. Use of antibiotics prior to delivery (excluding prophylactic antibiotics administered at delivery) 4\. Patients taking immunosuppressive drugs 5\. History of adhesive allergy or allergic skin diseases 6\. Patients unable to complete the required follow-up schedule 7\. Patients who did not consent or were unable to understand the study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Scar Cosmesis assessed by Patient Scar Assessment Scale (PSAS) | 1 week post-discharge, 1 month post-operatively, and 6 months post-operatively | Scar cosmesis was evaluated using the Patient Scar Assessment Scale (PSAS), a validated patient-reported outcome measure. The PSAS assesses six subjective scar characteristics: pain, itching, color difference, stiffness, thickness, and irregularity. Each item is scored on a numerical scale from 1 (normal/no symptoms) to 10 (worst imaginable/most different from normal skin), yielding a total score ranging from 6 to 60. A lower score indicates better scar cosmesis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Surgical Site Infection (SSI) | During hospitalization (postoperative day 2 and day 4), 1 week post-discharge, and 1 month post-operatively | Surgical site infection was assessed by clinical inspection for signs including redness, edema, pain, heat, pustules, discharge, fever, or odor. SSI was classified as superficial or deep, and the need for antibiotic therapy was recorded. |
Countries
South Korea
Outcome results
None listed