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Completed

NCT Number: NCT03264573

Role of Stem Cells, Platelet Rich Plasma in Treatment of Scars

The Objectives of this randomized controlled trial aiming to establishing a protocol of post scar revision care and to Study the effect of PRP and/or Adipose derived Mesenchymal Stem cell injection in improvement of atrophic scar after scar revision.

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Key information

Conditions

Atrophic Scar

Age range

10 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Forty patients with atrophic scar since one to five years including 25 males and 15 females with ages ranging from ten to 35 years with main age of 22.68 will be divided into four groups each included ten patients. One group will be treated with scar revision only (control group or group I), 2nd group will be injected with PRP after scar revision, 3rd group will be injected with ADSCs after scar revision and the 4th group will be injected with a combination of PRP and ADSCs after scar revision. All groups were assisted pre-operative and six months post-operative. Complications, Scar width, Vancouver scar scale (VSS), surgeon assessment scar scale and patient assessment scar scale will be considered the outcome measurements.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patient with atrophic scar.
  • Age group: 5 years up to 35 years.
  • No previous medications, surgeries or laser therapy.

Exclusion criteria

  • Patient with hypertrophic or pigmented scar.
  • Patient with any blood disease.
  • Patients with lipodystrophy.

Treatment and study plan

Stem cell

Biological

after scar revision PRP is injected intradermally, also adipose derived mesenchymal stem cells

Other names: PRP

MSCs

Device

manual separation of platelets rich plasma and undifferentiated mesenchymal stem cells

Other names: Stem cell and PRP

Primary outcomes

  1. Patient satisfaction (Patient Assessment Scar Scale)

    Time frame: 6 months

    Patient Assessment Scar Scale

Secondary outcomes

  1. Doctor satisfaction (Vancouver Scar Scale)

    Time frame: 6 months

    Vancouver Scar Scale (VSS)

Sponsors and collaborators

Lead sponsor

Heba Mohamed Saad Eldien

Other

Collaborators

  • Ahmed Kamal Osman
  • G.M. Hafsa
  • M.A. Eloteify

Registry information

Official study title

Role of Stem Cells, Platelet Rich Plasma and Combination of Them in Treatment of Scars

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 29, 2017
Registry last updated
Aug 29, 2017

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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