Platelet Rich Plasma and Wound Healing After Cesarean Section

NCT04669353 | Completed Phase 4

• 1 other identifier: 198190PSGN33
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: To assess the effect of autologous Platelet Rich Plasma (PRP) on wound healing and pain perception in high risk women undergoing cesarean sections in a low resource setting. Methods: This was a randomized controlled trial of 200 women who attended the outpatient clinic of Menoufia University Hospital for elective cesarean surgery. The women were randomly assigned to two groups. The intervention group received PRP after surgery, whereas the control group received the usual care. Outcomes included Redness, Edema, Ecchymosis, Discharge, Approximation (REEDA) scale, Vancouver scar scale (VSS), and the visual analog scale (VAS).

Conditions

Infection

Keywords

Platelet Rich Plasma; wound Healing; Pain; Cesarean Section

Outcome Measures

Primary Outcomes (1)

• Redness, Edema, Ecchymosis, Discharge, Approximation scale changes

  for assessing the changes in wound healing. REEDA as a descriptive scale has 4 points in a categorical score that measures 5 items of healing: redness (hyperemia), edema, ecchymosis, discharge, and approximation of the wound edges (coaptation). Each item is rated on a scale of 0 to 3, and total scores may range from 0 to 15. A lower score indicates better healing

  day 1, day 7 and 6 months

Secondary Outcomes (2)

• Vancouver scar scale changes.

  day 1, day7, and 6 months

• Visual Analog Scale changes

  day 1, day7, and 6 months

Study Arms (2)

Platelet Rich Plasma

ACTIVE COMPARATOR

In the operating room before the start of each procedure, approximately 15 cm of whole blood was drawn from the uninvolved arm of each patient in the intervention group (group I) into a 20 ml sterile syringe containing citrate for anticoagulation. The blood was immediately centrifuged at 3200 Revolutions per Minute (PRM). Following 15 minutes of centrifugation, 4 - 5 mL of PRP was obtained. Then, the PRP was buffered by using sodium bicarbonate. After closure of the fascia and prior to skin closure, PRP was directly applied to the subcutaneous tissue of the wound site by using a sterile syringe.

Drug: Platelet rich plasma

control group

NO INTERVENTION

In the control group (group II), the patients did not receive topical treatment and the subcutaneous tissue was cleaned with normal saline before skin closure

Interventions

Platelet rich plasma DRUG

approximately 15 cm of whole blood was drawn from the uninvolved arm of each patient in the intervention group (group I) into a 20 ml sterile syringe containing citrate for anticoagulation. The blood was immediately centrifuged at 3200 Revolutions per Minute (PRM). Following 15 minutes of centrifugation, 4 - 5 mL of PRP was obtained. Then, the PRP was buffered by using sodium bicarbonate.

Platelet Rich Plasma

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index (BMI) \> 30 kglcm2
• prior cesarean section
• pregestational or gestational diabetes
• hypertensive disorders of pregnancy
• placenta Previa
• twin pregnancy
• anemia
• corticosteroid medication

You may not qualify if:

• chronic pain disorders
• hepatitis
• thrombocytopenia
• coagulation disorders

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Menoufia university hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Infections; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nabih Elkhouly

  Faculty of medicine, Menoufia University, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The invesigators randomized participants in a 1:1 ratio to two equal groups containing one hundred patients each (intervention and control groups). A statistician not directly involved in the study prepared a computer generated randomization list and placed the allocation information in sequentially numbered sealed envelopes that were opened according to the attendance of the patients after signing the informed consent. The study authors were unaware of the envelope allocation sequence. Participants and outcome assessors did not know which group had been assigned to for the duration of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: December 6, 2020
• First Posted: December 16, 2020
• Study Start: April 1, 2018
• Primary Completion: July 1, 2020
• Study Completion: December 30, 2020
• Last Updated: August 18, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)