Back to resultsClinic Trial in Phase 1 Using Amniotic Membrane for the Skin Replacement in Big Wounds
Primary Purpose
Wound
Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Amniotic membrane in big wounds
Sponsored by
About this trial
This is an interventional treatment trial for Wound focused on measuring Skin, Injury, Membrane amniotic, Wound
Eligibility Criteria
Inclusion Criteria:
- Acute wounds in granulation phase with a minimum surface of 100cm2
- ≥ 18 years
- signing informed consent form
- guarantee adherence to protocol
Exclusion Criteria:
- chronic arterial insufficiency
- pregnant patients, lactating women or fertile adults that they don't use an effective contraceptive method
- involved in other assay
- previous disease; kidney, heart, hepatic, systemic or immune
- inability to understand informed consent form
Sites / Locations
- Gregorio Castellanos Escrig MD
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
amniotic membrane in big wounds
Arm Description
The wound will be washed with saline and debrided if necessary. Control microbiological cultures will be taken and applied amniotic membrane fragments sufficient to cover the wound, putting in contact the basement membrane of the AM with granulation tissue
Outcomes
Primary Outcome Measures
serious adverse events
inflammatory changes
Secondary Outcome Measures
wound evaluation
inflammatory condition of the wound,surface,
immunological evaluation
anti Human Leukocyte Antigen 1 (HLA1),Short Tandem Repeat (STRS) detection
histological evaluation
Transforming growth factor beta 1 or Transforming growth factor beta (TGFB),wound biopsy
microbiological evaluation
microbiological culture
Full Information
NCT ID
NCT01948934
First Posted
September 19, 2013
Last Updated
March 24, 2017
Sponsor
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
1. Study Identification
Unique Protocol Identification Number
NCT01948934
Brief Title
Clinic Trial in Phase 1 Using Amniotic Membrane for the Skin Replacement in Big Wounds
Official Title
Clinic Trial in Phase 1 Using Amniotic Membrane for the Skin Replacement in Big Wounds
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
February 6, 2017 (Actual)
Study Completion Date
February 6, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine the safety of use of a new therapeutic strategy for the treatment of patients with large wounds
Detailed Description
Amniotic membrane (AM) is a useful tissue as a biological dressing with numerous advantages it has a very similar structure to the skin and his biological and immunological properties.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound
Keywords
Skin, Injury, Membrane amniotic, Wound
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
amniotic membrane in big wounds
Arm Type
Experimental
Arm Description
The wound will be washed with saline and debrided if necessary. Control microbiological cultures will be taken and applied amniotic membrane fragments sufficient to cover the wound, putting in contact the basement membrane of the AM with granulation tissue
Intervention Type
Procedure
Intervention Name(s)
Amniotic membrane in big wounds
Intervention Description
The wound will be washed with saline and debrided if necessary. Control microbiological cultures will be taken and applied amniotic membrane fragments sufficient to cover the wound, putting in contact the basement membrane of the AM with granulation tissue
Primary Outcome Measure Information:
Title
serious adverse events
Time Frame
12 months
Title
inflammatory changes
Time Frame
12 months
Secondary Outcome Measure Information:
Title
wound evaluation
Description
inflammatory condition of the wound,surface,
Time Frame
12 months
Title
immunological evaluation
Description
anti Human Leukocyte Antigen 1 (HLA1),Short Tandem Repeat (STRS) detection
Time Frame
12 months
Title
histological evaluation
Description
Transforming growth factor beta 1 or Transforming growth factor beta (TGFB),wound biopsy
Time Frame
12 months
Title
microbiological evaluation
Description
microbiological culture
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Acute wounds in granulation phase with a minimum surface of 100cm2
≥ 18 years
signing informed consent form
guarantee adherence to protocol
Exclusion Criteria:
chronic arterial insufficiency
pregnant patients, lactating women or fertile adults that they don't use an effective contraceptive method
involved in other assay
previous disease; kidney, heart, hepatic, systemic or immune
inability to understand informed consent form
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregorio Castellanos Escrig, MD
Organizational Affiliation
Hospital Clinico Universitario Virgen de la Arrixca
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gregorio Castellanos Escrig MD
City
Murcia
State/Province
El Palmar
ZIP/Postal Code
30120
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Clinic Trial in Phase 1 Using Amniotic Membrane for the Skin Replacement in Big Wounds
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