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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2024-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental: PRP Group

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

Group Type EXPERIMENTAL

Platelet-Rich Plasma (PRP) intraoperatively

Intervention Type OTHER

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

Control: No Intervention Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Platelet-Rich Plasma (PRP) intraoperatively

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes