Skip to main content
OpenTrials
Completed

NCT Number: NCT06978010

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Saint Andrew Hospital

Constanța, Constanța County, 900591, Romania

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Patient and Observer Scar Assessment Scale (POSAS)

    Time frame: 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 outcomes

  1. Visual Analog Scale (VAS)

    Time frame: 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

  2. Redness, Erythema, Edema, Ecchymosis, Discharge

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Saint Andrew Hospital Constanta

Other

Registry information

Acronym: PRP06081992

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 18, 2025
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.