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

Complication Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01519362
• Other study ID #: zhangduo
• Status: Completed
• Phase: N/A
• First received: January 24, 2012
• Last updated: January 25, 2012
• Start date: October 2011

Study information

• Verified date: January 2012
• Source: First Hospital of Jilin University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 50 Years

Eligibility

Inclusion Criteria:

• PAAG injected into bilateral temporal epicranial aponeurosis

Exclusion Criteria:

• PAAG injected into other parts of the body

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Complication

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Duo Zhang