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

NCT06978010 | Completed DMC

• 2 other identifiers: AB-06081992Saint Andrew Hospital Ethics
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

cesarean section wound; Platelet- Rich Plasma; Regenerative Medicine; Wound Healing

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Visual Analog Scale (VAS)

  up to 40 days

• Redness, Erythema, Edema, Ecchymosis, Discharge

  up to 40 days

Study Arms (2)

Experimental: PRP Group

EXPERIMENTAL

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

Other: Platelet-Rich Plasma (PRP) intraoperatively

Control: No Intervention Group

NO INTERVENTION

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

Interventions

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).

Experimental: PRP Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Eligible participants are individuals who self-identify as female and are scheduled to undergo cesarean section.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Saint Andrew Hospital Constanta: lead

Study Sites (1)

Saint Andrew Hospital

Constanța, Constanța County, 900591, Romania

Location

Study Officials

• Vlad Iustin Tica, Proffesor

  Ovidius University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: April 27, 2025
• First Posted: May 18, 2025
• Study Start: February 1, 2023
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)