NCT03386175

Brief Summary

the aim of the study is to evaluate the efficiency of the therapy with negative pression (TPN) and instillation in the debridement of chronic wound

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

October 4, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 29, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2020

Completed
Last Updated

September 1, 2020

Status Verified

August 1, 2020

Enrollment Period

3.2 years

First QC Date

December 21, 2017

Last Update Submit

August 31, 2020

Conditions

Wound

Outcome Measures

Primary Outcomes (1)

  • percentage of fibrine

    percentage of fibrine

    1 day

Interventions

therapy with negative pression and instillationDEVICE

therapy with negative pression and instillation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with wound and fibrin more than 70%

You may qualify if:

  • wound with debridement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grenoble University hospital

Grenoble, 38700, France

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Therapeutics

Central Study Contacts

sophie blaise, MD PhD

CONTACT

0033476765547SBlaise@chu-grenoble.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2017

First Posted

December 29, 2017

Study Start

October 4, 2017

Primary Completion

December 3, 2020

Study Completion

December 3, 2020

Last Updated

September 1, 2020

Record last verified: 2020-08

Locations

FR(1)