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Comparison Between Skin Graft Versus Skin Graft and Stem Cell Application

NCT04219657 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2020-02-17

No results posted yet for this study

Summary

Trauma is the leading cause of soft tissue loss of the heel. Children constitute the largest group of victims of such injuries. Spoke wheel injury, road traffic accident are common mode in the children. Oestern and Tscherne have classified soft tissue injuries into four grades from 0-4. The treatment of Grade 0 and 1 injuries is typical cleansing and application of a moist wound healing dressing. But further grades need surgical management with debridement and reconstruction. Grade III and IV can be reconstructed by using graft, flaps or various other techniques. . Skin grafting offers poor functional and cosmetic results, although it is commonly performed with good take rates. mesenchymal stem cells will be isolated from umbilical cord with informed consent from the mothers. This study will open a new avenue for the treatment of heel pad injury. . Since the use of stem cell (especially in Pakistan) is completely a new technique in the management of heel pad injury, it will provide insight for better management by accelerating the wound healing process.

Conditions

  • Accidental Wound
  • Heel Injury
  • Stem Cell Transplant

Interventions

BIOLOGICAL

mesenchymal stem cell application

Sponsors & Collaborators

  • King Edward Medical University

    lead OTHER

Principal Investigators

  • FATIMA NAUMERI, assoc Prof · King Edward Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-29
Primary Completion
2019-12-20
Completion
2019-12-22

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04219657 on ClinicalTrials.gov