A Phase 2/3 interventional study of Platelets Rich plasma of the same patient in Wound Heal, Abdominal Wound and PRP, sponsored by Helwan University. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-08.
Sponsored by Helwan University · Phase 2/3, Interventional, and Prevention
To evaluate the effect of PRP on wound healing in high risk patients undergoing abdominal hysterectomy.
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.
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
This study's planned enrollment of 80 is above the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.
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Exclusion Criteria:
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
Biological: Platelets Rich plasma of the same patient
the patients received no topical treatment in the subcutaneous tissue or the skin before closure during surgery
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
changes in wound healing
REEDA descriptive scale will assess degree of wound healing which formed of 4 points in a categorical score assessing 5 items of healing, redness, edema,ecchymosis, discharge approximation of the wound edges, each item is rated on a scale of 0-3 and total score may range between 0-15. lower scores indicating good healing
Time frame: day 1, day 7, and day 30
Vancouver scar scale changes
Vancouver scar scale (VSS) use to detect changes of formation of keloids or hypertrophic scars. It assesses 4 subjective variables: vascularity, height/thickness, pliability, and pigmentation within a possible range of 0-14 for the total score. A lower score indicates better healing.
Time frame: day 1, day 7, and day 30
Visual Analog Scale changes
Pain was evaluated by the visual analog scale system (VAS) which assesses changes of pain via a continuous measurement instrument. The score is determined by measuring the distance (mm) between the no pain anchor to the point that the patient marks, providing a range of scores from 0-10. A higher score indicates greater pain intensity
Time frame: day 1, day 7, and day 30
Hospital readmission
Need to hospital readmission due to wound complications
Time frame: 1 month post-operatively
Infection
Presence of infection after surgery
Time frame: Up to 1 month
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