Study of Tissue Expansion Devices Complications (STEDC)

Air Force Military Medical University of People's Liberation Army

Status: Unknown

Conditions: Tissue Expansion

Treatments: Behavioral: manuals and follow-up

Study type: Interventional

Funder types: Other

Identifiers

NCT03084887

KY20162083-1

Details and patient eligibility

About

Reduce the common complications incidence about patients placed tissue expansion devices to around 5%.

Full description

Study design： Randomized parallel controlled trial. Study comments: 1.Telephone follow-up trainment group about 2-3 months until secondary hospital. 2.Promote the health management manual of patient placed expander,which includes discharge list, injection list, expander affusion operation procedure, injection myth, you ask me answer,injection record, injection diary record, appointment diaries etc.

Enrollment: 208 estimated patients

Sex: All

Ages: 1 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• aged 1-70 years male and female;
• no complication when inclusion;
• sign the informed consent.

Exclusion criteria

• joined other clinical trial;
• occurred complications before inclusion;
• other infectious diseases;
• the pregnant or lactating women.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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208 participants in 2 patient groups

manuals and follow-up

Experimental group

Description:

distribute manuals for patients before discharge and telephone follow-up per week until secondary hospital

Treatment:

Behavioral: manuals and follow-up

controlled group

No Intervention group

Description:

no intervention until secondary hospital