A Woman Suffered From Leukocytopenia and Widespread Migration After Polyacrylamide Hydrogel (PAAG) Injection in Epicranial Aponeurosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01519362
Recruitment Status : Completed
First Posted : January 26, 2012
Last Update Posted : January 26, 2012
Information provided by (Responsible Party):
Duo Zhang, First Hospital of Jilin University

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 .

Condition or disease

Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Study Start Date : October 2011

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
A 50-year-old lady had PAAG injected into her bilateral temporal epicranial aponeurosis for augmentation

Inclusion Criteria:

  • PAAG injected into bilateral temporal epicranial aponeurosis

Exclusion Criteria:

  • PAAG injected into other parts of the body

Responsible Party: Duo Zhang, professor, First Hospital of Jilin University Identifier: NCT01519362     History of Changes
Other Study ID Numbers: zhangduo
First Posted: January 26, 2012    Key Record Dates
Last Update Posted: January 26, 2012
Last Verified: January 2012

Keywords provided by Duo Zhang, First Hospital of Jilin University:
Polyacrylamide hydrogel
epicranial aponeurosis
PAAG injection