NCT01824381

Brief Summary

The purpose of this study is to analyze the security application of the amniotic membrane in extensive wounds in the granulation phase.

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 Jul 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

July 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2013

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

March 30, 2017

Status Verified

March 1, 2017

Enrollment Period

4.7 years

First QC Date

April 1, 2013

Last Update Submit

March 29, 2017

Conditions

Wounds

Keywords

extensive woundsamniotic membranehealingpatientsphase granulation

Outcome Measures

Primary Outcomes (1)

  • Safety

    No serious adverse events possibly, probably or definitely related with the procedure. No appearance of clinical inflammatory changes.

    Last revision at 3 years after surgery.

Secondary Outcomes (3)

  • Measurement of the wound area

    3 years

  • Evolution of local pain measured with a visual analog scale

    1 year

  • Changes in the signaling pathways of TGFb.

    1 year

Study Arms (1)

Amniotic membrane in large wounds

EXPERIMENTAL
Procedure: Place amniotic membrane in large woundsProcedure: Obtaining and Cryopreservation of amniotic membraneDrug: amniotic membrane

Interventions

Place amniotic membrane in large woundsPROCEDURE

After the process of obtaining the amniotic membrane, it must be processed, frozen and thawed. The wound is washed with saline and, if necessary it will be debrided. We will take microbiological control cultures. Then apply the amniotic membrane fragments sufficient to cover the wound by contacting the basal membrane of the amniotic membrane with granulation tissue. We will place a new membrane weekly to a maximum of 6 times.

Amniotic membrane in large wounds
Obtaining and Cryopreservation of amniotic membranePROCEDURE
Amniotic membrane in large wounds
amniotic membraneDRUG
Amniotic membrane in large 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 area of 100 cm2.
  • Patients 18 or more years.
  • Patients offering sufficient guarantees of adherence to protocol.
  • Sign the written informed consent.

You may not qualify if:

  • Patients with symptomatic chronic arterial insufficiency.
  • Patients who are pregnant
  • Patients in active lactation
  • Patients physically fertile, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle or sexual orientation precludes intercourse with a man and women whose partners have been sterilized by vasectomy or other methods, UNLESS they are using reliable contraception. This method of contraception can be:
  • Complete abstinence from sexual intercourse
  • Surgical sterilization (tubal ligation)
  • Surgical sterilization of the partner (vasectomy)
  • Implanted or injectable hormonal contraceptives, oral \*
  • Because hormonal contraceptives have a risk of thrombosis, should consider other methods of birth control.
  • These reliable contraception must be maintained during their participation in the study.
  • Patients with heart, kidney, liver, systemic immune may influence the survival of the patient during the test.
  • Participation in other clinical trials.
  • Inability to understand informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Universitary Hospital Virgen de la Arrixaca

El Palmar, Murcia, 30120, Spain

Location

Related Links

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Biological Dressings

Intervention Hierarchy (Ancestors)

BandagesEquipment and Supplies

Study Officials

  • Gregorio Castellanos-Escrig, MD

    Clinical Universitary Hospital Virgen de la Arrixaca

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 1, 2013

First Posted

April 4, 2013

Study Start

July 1, 2012

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

March 30, 2017

Record last verified: 2017-03

Locations

ES(1)