Clinical trial NCT06298110: The Effect of PRP on Wound Healing in High Risk Patients Undergoing Abdominal Hysterectomy
Official title: The Effect of PRP on Wound Healing in High Risk Patients Undergoing Abdominal Hysterectomy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Wound Heal
Abdominal Wound
PRP
Keywords: PRP
Abdominal hysterectomy
Wound healing
Lead sponsor: Helwan University
Sponsor class: OTHER
First posted: 2024-03-07
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: changes in wound healing
timeFrame: day 1, day 7, and day 30
Secondary outcomes:
measure: Vancouver scar scale changes
timeFrame: day 1, day 7, and day 30
measure: Visual Analog Scale changes
timeFrame: day 1, day 7, and day 30
measure: Hospital readmission
timeFrame: 1 month post-operatively
measure: Infection
timeFrame: Up to 1 month
Other outcomes:
Locations:
Study officials:
affiliation: Helwan University
name: Shimaa Bilal, Professor
role: STUDY_CHAIR
References:
citation: Akca A, Yilmaz G, Koroglu N. Platelet Indices as the Predictor of Antibiotics Response in Surgical Wound Infections Following Total Abdominal Hysterectomy. Sisli Etfal Hastan Tip Bul. 2019 Jun 24;53(2):132-136. doi: 10.14744/SEMB.2019.46693. eCollection 2019.
citation: Fanning J, Murrain L, Flora R, Hutchings T, Johnson JM, Fenton BW. Phase I/II prospective trial of autologous platelet tissue graft in gynecologic surgery. J Minim Invasive Gynecol. 2007 Sep-Oct;14(5):633-7. doi: 10.1016/j.jmig.2007.05.014.
citation: Gohar MM, Ali RF, Ismail KA, Ismail TA, Nosair NA. Assessment of the effect of platelet rich plasma on the healing of operated sacrococcygeal pilonidal sinus by lay-open technique: a randomized clinical trial. BMC Surg. 2020 Sep 22;20(1):212. doi: 10.1186/s12893-020-00865-x.
citation: Madueke-Laveaux OS, Elsharoud A, Al-Hendy A. What We Know about the Long-Term Risks of Hysterectomy for Benign Indication-A Systematic Review. J Clin Med. 2021 Nov 16;10(22):5335. doi: 10.3390/jcm10225335.
citation: Moscicka P, Przylipiak A. History of autologous platelet-rich plasma: A short review. J Cosmet Dermatol. 2021 Sep;20(9):2712-2714. doi: 10.1111/jocd.14326. Epub 2021 Jul 14.
citation: Rodrigues M, Kosaric N, Bonham CA, Gurtner GC. Wound Healing: A Cellular Perspective. Physiol Rev. 2019 Jan 1;99(1):665-706. doi: 10.1152/physrev.00067.2017.
citation: Tehranian A, Esfehani-Mehr B, Pirjani R, Rezaei N, Sadat Heidary S, Sepidarkish M. Application of Autologous Platelet-Rich Plasma (PRP) on Wound Healing After Caesarean Section in High-Risk Patients. Iran Red Crescent Med J. 2016 May 17;18(7):e34449. doi: 10.5812/ircmj.34449. eCollection 2016 Jul.
citation: Veevers-Lowe J, Ball SG, Shuttleworth A, Kielty CM. Mesenchymal stem cell migration is regulated by fibronectin through alpha5beta1-integrin-mediated activation of PDGFR-beta and potentiation of growth factor signals. J Cell Sci. 2011 Apr 15;124(Pt 8):1288-300. doi: 10.1242/jcs.076935. Epub 2011 Mar 23.