ClinicalTrials.gov
ClinicalTrials.gov Menu

Autologous Keratinocyte Suspension Versus Adipose-Derived Stem Cell-Keratinocyte Suspension for Post-Burn Raw Area

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03686449
Recruitment Status : Not yet recruiting
First Posted : September 27, 2018
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
Sara Diefy Salem, Assiut University

Brief Summary:

In this study

  1. Assess the efficiency of non-cultured autologous keratinocyte suspension in treating post-burn raw area.
  2. Compare the results of keratinocyte suspension alone versus Adipose-derived mesenchymal stem cells-keratinocyte suspension in post-burn raw area.

Condition or disease Intervention/treatment Phase
Burn With Full-Thickness Skin Loss Procedure: Non-cultured Autologous Keratinocyte Suspension Procedure: Adipose-Derived Stem cell-Keratinocyte Suspension Procedure: Split skin graft Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Non-cultured Autologous Keratinocyte Suspension Versus Adipose-Derived Stem Cell-Keratinocyte Suspension for Coverage of Post-Burn Raw Area: A Comparative Clinical Study
Estimated Study Start Date : November 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Arm Intervention/treatment
Experimental: study group 1
Non-cultured Autologous Keratinocyte Suspension
Procedure: Non-cultured Autologous Keratinocyte Suspension
New method for treatment of post-burn raw area

Experimental: study group 2
Adipose-Derived Stem cell-Keratinocyte Suspension
Procedure: Adipose-Derived Stem cell-Keratinocyte Suspension
New method for treatment of post-burn raw area

Active Comparator: Control group
Split skin graft
Procedure: Split skin graft
Traditional method for treatment of post-burn raw area




Primary Outcome Measures :
  1. Length of the operating procedure [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. The mean time to 95% healing of the burn wound [ Time Frame: 1 month ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Post-burn raw area more than 10% total body surface area

Exclusion Criteria:

  • Presence of pre-existing local and systemic bacterial infections.
  • Pre-existing medical conditions that would interfere with wound healing (i.e. uncontrolled diabetes mellitus, malignancy, congestive heart failure, autoimmune disease, renal failure, corticosteroids and immunosuppressive drugs).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03686449


Contacts
Contact: Mohamed Shazly, M.D 01006667095 elshazly@aun.edu.eg
Contact: Ahmed Tohamy, M.D 01002660832 ahmedtohamy92@gmail.com

Sponsors and Collaborators
Assiut University

Publications:

Responsible Party: Sara Diefy Salem, Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03686449     History of Changes
Other Study ID Numbers: NAKS-ADS
First Posted: September 27, 2018    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Burns
Wounds and Injuries