Cesarean Section Wound, Platelet-rich Plasma (PRP), Regenerative Medicine
Conditions
Keywords
cesarean section wound, Platelet- Rich Plasma, Regenerative Medicine, Wound Healing
Brief summary
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.
Detailed description
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.
Interventions
OTHERPlatelet-Rich Plasma (PRP) intraoperatively
Patients receive platelet-rich plasma (PRP) intraoperatively during cesarean section (5 ml before hysterography, 5 ml subcutaneously before skin closure).
Sponsors
Saint Andrew Hospital Constanta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Female patients, 18 to 45 years old. Scheduled for elective or emergency cesarean section at the participating center. * Singleton pregnancy (one fetus). Ability to provide written informed consent. Agreement to comply with the study protocol and follow-up visits at day 7 and day 40 postpartum.
Exclusion criteria
* Known coagulation disorders (e.g., thrombocytopenia, hemophilia). Platelet count below 150,000/μL at the time of enrollment. Use of anticoagulant or antiplatelet therapy within 7 days before surgery. Active infection at the surgical site. History of autoimmune diseases affecting wound healing (e.g., lupus, scleroderma). * Known keloid formation tendency (optional: include if you want to exclude high-risk scarring profiles). * Multiple pregnancies (twins, triplets, etc.). Patients participating in another interventional clinical trial could interfere with outcomes. * Inability to follow up for the postoperative evaluations at 7 and 40 days. Refusal to consent or withdrawal of consent at any point
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient and Observer Scar Assessment Scale (POSAS) | up to 40 days | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) | up to 40 days | 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 |
| Redness, Erythema, Edema, Ecchymosis, Discharge | up to 40 days | 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 |
Countries
Romania
Outcome results
None listed