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

NCT06298110 | Not Yet Recruiting Phase 2

• 1 other identifier: PRP in Abdominal hysterectomy
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Wound Heal; Abdominal Wound; PRP

Keywords

PRP; Abdominal hysterectomy; Wound healing

Outcome Measures

Primary Outcomes (1)

• 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

  day 1, day 7, and day 30

Secondary Outcomes (4)

• Vancouver scar scale changes

  day 1, day 7, and day 30

• Visual Analog Scale changes

  day 1, day 7, and day 30

• Hospital readmission

  1 month post-operatively

• Infection

  Up to 1 month

Study Arms (2)

PRP group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

Platelets Rich plasma of the same patient BIOLOGICAL

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

PRP group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

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

Sponsors & Collaborators

• Helwan University: lead

Related Publications (8)

• 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.

  PMID: 32377071 BACKGROUND

• 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.

  PMID: 17848327 BACKGROUND

• 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.

  PMID: 32962673 BACKGROUND

• 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.

  PMID: 34830617 BACKGROUND

• 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.

  PMID: 34214233 BACKGROUND

• 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.

  PMID: 30475656 BACKGROUND

• 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.

  PMID: 27660723 BACKGROUND

• 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.

  PMID: 21429937 BACKGROUND

Related Links

• Impact of hysterectomy on uterine cancer incidence rates in Egypt

Study Officials

• Shimaa Bilal, Professor

  Helwan University

  STUDY CHAIR

Central Study Contacts

Ahmed El Sayed, M.B.B.Ch

CONTACT

01119228215; ahmed_mohammed_ahmed@med.helwan.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: March 7, 2024
• Study Start: March 10, 2024
• Primary Completion: August 25, 2024
• Study Completion: September 25, 2024
• Last Updated: March 8, 2024

Record last verified: 2024-02