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Completed

NCT Number: NCT04430413

Effect of Platelet Rich Plasma on Healing of Operated Pilonidal Sinus by Open Method

The aim of the study is to assess the healing promotion effect of platelet rich plasma in patient being operated for sacrococcygeal pilonidal sinus disease by open excision

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kafr El Sheikh University Hospital

Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33511, Egypt

About this study

Sacrococcygeal Pilonidal disease is an infection of the skin and subcutaneous tissue at or near the upper part of the natal cleft of the buttocks. Pilonidal cavities are not true cysts and lack a fully epithelialized lining; however, the sinus tracts may be epithelialized.

Pilonidal sinus disease (PNS) has an incidence of approximately 26 per 100,000 population with a male predominance of 2:1 and the mean age of those affected is from 19 to 30 years of age. It occurs rarely after the age of 45 and children.

Pilonidal sinus disease is characterized by natal cleft suppuration due to hair follicle infection. The disease results from chronic infection of hair follicles and subsequent formation of a subcutaneous abscess because of persistent folliculitis. Hair then enters the abscess cavity and provokes a foreign body tissue reaction; chronic suppuration and discharge through a midline sinus follow.

Some individuals are asymptomatic with midline pits in the sacrococcygeal area, Symptomatic Pilonidal sinus results in chronic discharging wounds that cause pain and impact upon quality of life and social function. These sinuses may become infected and present as acute abscesses. Management of these abscesses is uncontroversial and revolves around incision and drainage, however, the mode of surgical management of the chronic discharging sinus is variable, contentious, and problematic.

The Principles of Surgical strategies require eradication of the sinus tract, complete healing of the overlying skin, and prevention of recurrence. Many methods are available for surgical management of PNS which is treated by wide excision. After excision, the wound may be left open to heal with granulation tissue, or may be immediate closed with a midline closure or by using a flap (Z-plasty, karydakis, Bascom or Rhomboid flaps). However, there is not yet a consensus on the optimal treatment.

Excision and healing by granulation is still preferred due to the low recurrence rate of (3.4%) compering with other methods (20.6%) for midline closure and (10.3%) for off-midline closure but the healing time is lengthy and requires a prolonged time of daily dressing with a risk of infection and delayed wound healing. Therefore, the search for a treatment with minimal pain, accelerated healing time and a short span of time for returning to the normal daily activities is vastly pursued.

A recent method to promote the wound-healing process is the local administration of an autologous platelet concentrate suspended in plasma named as platelet rich plasma (PRP) which contains growth factors. Concentrated growth factors have been reported to accelerate wound healing by 30-40% giving a satisfactory outcome in the treatment of chronic skin and soft tissue lesions, maxillofacial and plastic surgeries by presenting these high amounts of growth factors and chemokines.

When platelets become activated, Seven fundamental protein growth factors that are actively secreted by platelet initiate 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 (ILGF 1) all participate in the acceleration of wound-healing process.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient age >18 years and <45 years.
  • All patient who underwent sacrococcygeal pilonidal sinus operation (Open method).

Exclusion criteria

  • Pilonidal abscess.
  • Diabetic patient.
  • HGB < 10 g/dl.
  • Platelet count < 105/ul.
  • Anticoagulant treatment.
  • Wound cavity >35cc.

Treatment and study plan

Platelet rich plasma

Biological

Autologous PRP obtained via double centrifugation process of the participant's blood sample. PRP was prepared by the double Spain strategy.

Primary outcomes

  1. Assessment of the wound capacity

    Time frame: One Year

    Evaluation of Wound volume on postoperative days till complete healing of the wound in each group and compare rate of healing in both groups.

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Official study title

Assessment of the Effect of Platelet Rich Plasma on the Healing of Operated Sacrococcygeal Pilonidal Sinus by Open Method

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 12, 2020
Registry last updated
Jun 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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