Clinical trial NCT06978010: Efficacy of Platelet-rich Plasma in Improving Postoperative Scarring After Cesarean Delivery
Official title: Efficacy of Platelet-rich Plasma in Improving Postoperative Scarring After Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section Wound
Platelet-rich Plasma (PRP)
Regenerative Medicine
Keywords: cesarean section wound
Platelet- Rich Plasma
Regenerative Medicine
Wound Healing
Lead sponsor: Saint Andrew Hospital Constanta
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient and Observer Scar Assessment Scale (POSAS)
timeFrame: up to 40 days
Secondary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: up to 40 days
measure: Redness, Erythema, Edema, Ecchymosis, Discharge
timeFrame: up to 40 days
Other outcomes:
Locations:
city: Constanta
country: Romania
facility: Saint Andrew Hospital
Study officials:
affiliation: Ovidius University
name: Vlad Iustin Tica, Proffesor
role: STUDY_CHAIR
References: