NCT01519362

Brief Summary

Polyacrylamide hydrogel (PAAG) has been used as an injectable filler for soft tissue augmentation in different parts of the body , such as face, breast , or even penis for more than a decade . However, there are never reports about the application of a large amount of PAAG in epicranial aponeurosis to change the contour of the upper cranium accompanied with leukocytopenia. This fancy application turned out to be a disaster for the women who suffered from leukocytopenia , widespread migration of PAAG, recurrent swelling of the affected tissues and temporal pain changing with the temperature and the facial expression .

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 26, 2012

Completed
Last Updated

January 26, 2012

Status Verified

January 1, 2012

First QC Date

January 24, 2012

Last Update Submit

January 25, 2012

Conditions

Complication

Keywords

Polyacrylamide hydrogelleukocytopeniamigrationcomplicationepicranial aponeurosisPAAG injection

Eligibility Criteria

Age50 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

A 50-year-old lady had PAAG injected into her bilateral temporal epicranial aponeurosis for augmentation

You may qualify if:

  • PAAG injected into bilateral temporal epicranial aponeurosis

You may not qualify if:

  • PAAG injected into other parts of the body

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Leukopenia

Condition Hierarchy (Ancestors)

CytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte Disorders

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 24, 2012

First Posted

January 26, 2012

Study Start

October 1, 2011

Last Updated

January 26, 2012

Record last verified: 2012-01