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| ID | Type | Description | Link |
|---|---|---|---|
| Saint Andrew Hospital Ethics | Other Identifier | Saint Andrew Hospital Ethics Committee |
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Cesarean section often leads to postoperative scarring, which can impact both physical and psychological well-being. Platelet-rich plasma (PRP), rich in growth factors, is used in regenerative medicine to promote healing and reduce inflammation.
Background:
Cesarean section often leads to postoperative scarring, which can impact both physical and psychological well-being. Platelet-rich plasma (PRP), rich in growth factors, is used in regenerative medicine to promote healing and reduce inflammation.
Objective:
To evaluate the efficacy of intraoperative PRP in accelerating scar healing after cesarean section, using:
Six visual scar assessment scales (Manchester, POSAS, Vancouver, VAS, NRS, REEDA) Hematological parameters (hemoglobin, hematocrit, leukocytes, platelets)
Methods:
Design: Prospective clinical study, 100 patients undergoing cesarean section with intraoperative PRP.
Intervention: 10 ml PRP administered intraoperatively (5 ml before hysterography, 5 ml subcutaneously before skin closure).
Assessments: Scar evaluation at day 7 and day 40 post-op using six scar scales; hematological parameters measured at both time points.
Statistics: Wilcoxon paired samples test and Pearson correlation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: PRP Group | Experimental | Patients receive platelet-rich plasma (PRP) intraoperatively during cesarean section (5 ml before hysterography, 5 ml subcutaneously before skin closure). |
|
| Control: No Intervention Group | No Intervention | Patients undergo standard cesarean section with no PRP administration or placebo. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet-Rich Plasma (PRP) intraoperatively | Other | Patients receive platelet-rich plasma (PRP) intraoperatively during cesarean section (5 ml before hysterography, 5 ml subcutaneously before skin closure). |
| Measure | Description | Time Frame |
|---|---|---|
| Patient and Observer Scar Assessment Scale (POSAS) | The Patient and Observer Scar Assessment Scale (POSAS) POSAS Score Overview: Scale range: Each item is scored from 1 to 10 Minimum total score: 6 (best possible scar) Maximum total score: 60 (worst possible scar) Higher scores indicate worse scar quality Lower scores indicate better scar quality (closer to normal skin) | up to 40 days |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) | 0 = "No pain" 10 = "Worst imaginable pain" Scoring: The patient marks a point on the line corresponding to their perceived symptom intensity. 0 = no pain/symptom 10 = worst possible pain/symptom Higher scores = worse symptoms | up to 40 days |
| Redness, Erythema, Edema, Ecchymosis, Discharge |
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Inclusion Criteria:
Exclusion Criteria:
Eligible participants are individuals who self-identify as female and are scheduled to undergo cesarean section.
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| Name | Affiliation | Role |
|---|---|---|
| Vlad Iustin Tica, Proffesor | Ovidius University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Andrew Hospital | Constanța | Constanța County | 900591 | Romania |
This study does not plan to make individual participant data available due to privacy considerations and the lack of specific data-sharing agreements. Aggregated results will be published in peer-reviewed journals.
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Study Type Interventional Interventional Model Parallel Assignment Number of Arms 2 (PRP Group vs. Placebo/Control Group) Masking (Blinding) Single-blind, Primary Purpose Treatment Allocation Randomized
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Change in REEDA score (Erythema, Edema, Ecchymosis, Discharge, Approximation) as an indicator of inflammation and healing. Total Score Range: Minimum: 0 → Excellent healing Maximum: 15 → Poor healing / possible infection 0-4: Normal or mild changes; generally satisfactory healing 5-7: Moderate impairment; monitor healing 8-15: Significant impairment; possible infection or dehiscence; needs medical attention |
| up to 40 days |