NCT01948934

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2012

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 24, 2013

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2017

Completed
Last Updated

March 27, 2017

Status Verified

March 1, 2017

Enrollment Period

4.7 years

First QC Date

September 19, 2013

Last Update Submit

March 24, 2017

Conditions

Wound

Keywords

SkinInjuryMembrane amnioticWound

Outcome Measures

Primary Outcomes (2)

  • serious adverse events

    12 months

  • inflammatory changes

    12 months

Secondary Outcomes (4)

  • wound evaluation

    12 months

  • immunological evaluation

    12 months

  • histological evaluation

    12 months

  • microbiological evaluation

    12 months

Study Arms (1)

amniotic membrane in big wounds

EXPERIMENTAL

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

Procedure: Amniotic membrane in big wounds

Interventions

Amniotic membrane in big woundsPROCEDURE

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

amniotic membrane in big wounds

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute wounds in granulation phase with a minimum surface of 100cm2
  • ≥ 18 years
  • signing informed consent form
  • guarantee adherence to protocol

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gregorio Castellanos Escrig MD

Murcia, El Palmar, 30120, Spain

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Gregorio Castellanos Escrig, MD

    Hospital Clinico Universitario Virgen de la Arrixca

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2013

First Posted

September 24, 2013

Study Start

June 1, 2012

Primary Completion

February 6, 2017

Study Completion

February 6, 2017

Last Updated

March 27, 2017

Record last verified: 2017-03

Locations

ES(1)