Efficacy of Platelet-rich Plasma in Improving Postoperative Scarring After Cesarean Delivery (PRP06081992)

Saint Andrew Hospital Constanta

Status: Completed

Conditions: Cesarean Section Wound; Platelet-rich Plasma (PRP); Regenerative Medicine

Treatments: Other: Platelet-Rich Plasma (PRP) intraoperatively

Study type: Interventional

Funder types: Other

Identifiers

NCT06978010

Saint Andrew Hospital Ethics (Other Identifier)

AB-06081992

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Experimental: PRP Group

Experimental group

Description:

Patients receive platelet-rich plasma (PRP) intraoperatively during cesarean section (5 ml before hysterography, 5 ml subcutaneously before skin closure).

Treatment:

Other: Platelet-Rich Plasma (PRP) intraoperatively

Control: No Intervention Group

No Intervention group

Description:

Patients undergo standard cesarean section with no PRP administration or placebo.