The Effect of PRP on Wound Healing in High Risk Patients Undergoing Abdominal Hysterectomy

Helwan University

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: PRP; Wound Heal; Abdominal Wound

Treatments: Biological: Platelets Rich plasma of the same patient

Study type: Interventional

Funder types: Other

Identifiers

NCT06298110

PRP in Abdominal hysterectomy

Details and patient eligibility

About

To evaluate the effect of PRP on wound healing in high risk patients undergoing abdominal hysterectomy.

Full description

Hysterectomy is one of the most common lines of surgical treatment of various uterine disorders as it provides definitive relief from the associated burdensome symptoms with an estimated prevalence of 13.1 per 10,000 women. The indications for hysterectomy include uterine leiomyomas (fibroid), dysfunctional uterine bleeding, endometrial adenomyosis, genital prolapse, massive postpartum hemorrhages and uterine cancers. Abdominal hysterectomy is still the most commonly used approach although there have been some preferences for vaginal and laparoscopic approaches.

Abdominal hysterectomy is associated with risk of complications. In high-risk women undergoing abdominal hysterectomy, wound healing can be particularly challenging due to a variety of factors, including poor tissue quality, compromised immune function, and underlying medical conditions.

Wound healing is a complex process that involves a series of events that are critical for the restoration of tissue integrity and function. Platelet-rich plasma (PRP) has emerged as a promising therapeutic option for enhancing wound healing in high risk patients. PRP is a concentrated source of platelets and growth factors derived from the patient's own blood. It has been shown to promote tissue regeneration and repair by stimulating cell proliferation, angiogenesis, and collagen synthesis. PRP has been used successfully in a variety of clinical settings, including orthopedics, dentistry, and dermatology.

PRP which contains concentrated growth factors have been reported to accelerate wound healing by30-40% giving a satisfactory outcome in the treatment of chronic skin and soft tissue lesions by supplying large amounts of growth factors and chemokines. When platelets become activated, they secrete Seven fundamental protein growth factors initiating all wound healing process, including platelet-derived growth factor (PDGF), epidermal growth factor (EGF), transforming growth factor (TGF), vascular endothelial growth factor (VEGF), Fibroblast growth factor (FGF), connective tissue growth factor (CTGF) & insulin like growth factor 1(ILGF 1), which participate in the acceleration of wound healing process.

A randomized controlled trial conducted by Tehranian et al. (2016) evaluated the use of PRP in high risk women after caesarian section. The study found that patients treated with PRP had significantly faster wound healing and a significant reduction in pain compared to those who received standard care. Similarly, another study by Fanning et al. (2007) investigated the use of PRP in women undergoing gynecologic surgery, there were no apparent adverse effects, and pain was significantly reduced.

In our study, we will investigate the effect of PRP on wound healing in high risk patients undergoing abdominal hysterectomy.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• • Female patients aged >18 years.
• Patients undergoing abdominal hysterectomy.
• Patients with a high risk of wound healing complications, including: obesity, diabetes mellitus, use of corticosteroid medication or smoking.

Exclusion criteria

• • Patients with hemoglobin (Hb) < 10 g/dL.
• Patients with platelet levels < 110 × 103/uL.
• Patients with coagulation disorders (on anticoagulant).
• Patients with malignancy

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

PRP group

Experimental group

Description:

on the morning of surgery, 30 mL of venous blood will be drawn from the patient in anticoagulant-containing PRP tube for preparation of PRP solution. The drawn blood will be centrifuged at 1,200 rpm for 12 minutes to be separated into three layers: an upper layer that contains platelets and white blood cells, an intermediate thin layer (the buffy coat) that is rich in white blood cells, and a bottom layer that contains red blood cells. The upper and intermediate buffy layers will be transferred to an empty sterile tube. The plasma will be centrifuged again at 3,300 rpm for 7 minutes to help with the formation of soft pellets (erythrocytes and platelets) at the bottom of the tube. Pellets are homogenized in the lower third (5 mL) of the plasma to create the PRP. The prepared PRP solution will be transferred within sterile single use syringe (3cm) from the laboratory to the operation room, then applied and spread over the subcutaneous space before skin closure

Treatment:

Biological: Platelets Rich plasma of the same patient

Control group

No Intervention group

Description:

the patients received no topical treatment in the subcutaneous tissue or the skin before closure during surgery