Cesarean Section WoundPRP06081992NCT06978010
Efficacy of Platelet-rich Plasma in Improving Postoperative Scarring After Cesarean Delivery
A study testing Platelet-Rich Plasma (PRP) intraoperatively in people with Cesarean Section Wound and Platelet-rich Plasma (PRP), run by Saint Andrew Hospital Constanta at 1 site in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section Wound, Platelet-rich Plasma (PRP), Regenerative Medicine
- What is being tested?
- Platelet-Rich Plasma (PRP) intraoperatively
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteRomania
- Study dates
- 1 Feb 2023to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Platelet-Rich Plasma (PRP) intraoperatively
- Keywords
- cesarean section wound, Platelet- Rich Plasma, Regenerative Medicine, Wound Healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-Rich Plasma (PRP) intraoperativelyOther
Patients receive platelet-rich plasma (PRP) intraoperatively during cesarean section (5 ml before hysterography, 5 ml subcutaneously before skin closure).
| Study group | Role | What they receive |
|---|---|---|
| Experimental: PRP Group | Experimental | Patients receive platelet-rich plasma (PRP) intraoperatively during cesarean section (5 ml before hysterography, 5 ml subcutaneously before skin closure). Receives: Other: Platelet-Rich Plasma (PRP) intraoperatively |
| Control: No Intervention Group | No intervention | Patients undergo standard cesarean section with no PRP administration or placebo. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: up to 40 days
Secondary outcomes (2)
Visual Analog Scale (VAS)
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
Measured: up to 40 days
Redness, Erythema, Edema, Ecchymosis, Discharge
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
Measured: up to 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start1 Feb 2023
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Andrew Hospital Constanta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brezeanu Dragos, Saint Andrew Hospital Constanta
- Investigators
- Vlad Iustin Tica, Proffesor, Study chair, Ovidius University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06978010
- Sponsor's protocol ID
- AB-06081992
- Other IDs
- Saint Andrew Hospital Ethics
- Acronym
- PRP06081992
- Status last verified
- May 2025
- First submitted
- 27 Apr 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study does not plan to make individual participant data available due to privacy considerations and the lack of specific data-sharing agreements. Aggregated results will be published in peer-reviewed journals.
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Platelet-rich Plasma in Improving Postoperative Scarring After Cesarean Delivery
- ClinicalTrials.gov ID
- NCT06978010
- Acronym / sponsor ID
- PRP06081992 / AB-06081992
- Keywords
- cesarean section wound, Platelet- Rich Plasma, Regenerative Medicine, Wound Healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Saint Andrew Hospital ConstantaUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 18 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Experimental: PRP Group | Experimental | Other: Platelet-Rich Plasma (PRP) intraoperativelyPatients receive platelet-rich plasma (PRP) intraoperatively during cesarean section (5 ml before hysterography, 5 ml subcutaneously before skin closure). |
| Control: No Intervention Group | No intervention | –Patients undergo standard cesarean section with no PRP administration or placebo. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet-Rich Plasma (PRP) intraoperativelyPatients receive platelet-rich plasma (PRP) intraoperatively during cesarean section (5 ml before hysterography, 5 ml subcutaneously before skin closure). | Other | Experimental: PRP Group |
Primary outcome
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)
2 secondary outcomes
Visual Analog Scale (VAS)
Time frame: up to 40 days
Redness, Erythema, Edema, Ecchymosis, Discharge
Time frame: up to 40 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Individual participant dataSharing planned: No. This study does not plan to make individual participant data available due to privacy considerations and the lack of specific data-sharing agreements. Aggregated results will be published in peer-reviewed journals.
Related trials for Cesarean Section Wound
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
Not yet recruitingObservational study
Pain After Scheduled Cesarean Delivery: Spinal Morphine With or Without Levobupivacaine Wound Infiltration
Pain Management, C Section
Not yet recruitingObservational study
Timing of Cesarean Wound Dressing Removal on Wound Healing in Women With BMI ≥ 30 kg/m²
Cesarean Section, Surgical Wound Infection
Recruiting
Narrative Nursing for Cesarean Mothers' Anxiety and Breastfeeding Confidence
Postpartum Anxiety, Postpartum Depression (PPD)
Not yet recruitingPhase 2
The Use of Photobiomodulation for Pain and Healing in Cesarean Section
Post Partum, Cesarean Birth
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vlad Iustin Tica, Proffesor study chair
Ovidius University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet-Rich Plasma (PRP) intraoperatively in people with Cesarean Section Wound and Platelet-rich Plasma (PRP), run by Saint Andrew Hospital Constanta at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient and Observer Scar Assessment Scale (POSAS) (time frame: up to 40 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.