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Recent clinical trials were developed to test the outcomes of skin closure with tissue adhesive, staples and monofilament synthetic suture after cesarean section with Pfannenstiel incision: both clinical outcomes such as blood loss, surgical site infection, length of postpartum hospitalization, or wound disruption, as well as Patient and Observer Scar Assessment Scale (POSAS) scores 8 weeks after surgery, were comparable between these different skin closure methods.
Despite the available studies are often based on robust methodologies and appropriate assessment scales, most of them were aimed to evaluate cosmetic outcomes in primary cesarean section, whereas data analyses published so far do not allow to draw a firm conclusion about repeated cesarean sections. Based on these elements, the aim of this study is to evaluate cosmetic outcomes after skin closure of Pfannenstiel incision with tissue adhesive or staples in a selected population undergoing repeated cesarean section.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Staples | Active Comparator | Women who underwent repeated cesarean section with skin closure using staples. |
|
| Tissue adhesive | Experimental | Women who underwent repeated cesarean section with skin closure using 2-octylcyanoacrylate tissue adhesive. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Staples | Procedure | Skin closure using surgical stapler. |
| |
| Tissue adhesive |
| Measure | Description | Time Frame |
|---|---|---|
| Observer Scar Assessment Scale (OSAS) score | The Observer Scar Assessment Scale (OSAS) rates 5 variables: vascularity, pigmentation, thickness, relief, and pliability. Each variable uses a 10-point scoring system, with 1 representing normal skin. Ratings of individual variables may be summed to obtain a total score ranging from 5-50, with 5 representing normal skin. | 6 months after repeated cesarean section |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Scar Assessment Scale (PSAS) score | The Patient Scar Assessment Scale (PSAS) consists of 6 items on scar-related pain, itchiness, color, stiffness, thickness, and irregularity. Each item uses a 10-point scoring system, summed to obtain a total score ranging from 6-60, with 6 representing normal skin with no associated symptoms. | 6 months after repeated cesarean section |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonella Cromi, M.D., Ph.D. | Università degli Studi dell'Insubria | Principal Investigator |
| Fabio Ghezzi, M.D. | Università degli Studi dell'Insubria | Study Chair |
| Antonio Simone Laganà , M.D., Ph.D. | Università degli Studi dell'Insubria | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale "Filippo Del Ponte" | Varese | Lombardy | 21100 | Italy |
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| ID | Term |
|---|---|
| D013537 | Sutures |
| D014014 | Tissue Adhesives |
| ID | Term |
|---|---|
| D053831 | Surgical Fixation Devices |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
| D001697 | Biomedical and Dental Materials |
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Single-center, prospective, randomized controlled trial
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| Procedure |
Skin closure using 2-octylcyanoacrylate tissue adhesive. |
|
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |