The Effects of Autologous Fat Transfer on Preventing Expanded Skin From Expansion Failure

NCT02809001 | Completed Phase 1

• 1 other identifier: Shanghai9PH
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate whether autologous fat grafting is safe and/or effective to prevent expanded skin from expansion failure.

Conditions

Scar; Nevus

Keywords

Fat grafting; Expansion-related complications

Outcome Measures

Primary Outcomes (2)

• To Measure the Change in Expansion Volume

  Record the volume(ml) of each expander

  Change from baseline volume at 12 weeks

• To Measure the Change in Skin Thickness

  Record the thickness of the expanded skin(cm) by ultrasound scanning

  Change from baseline skin thickness at 12 weeks

Secondary Outcomes (2)

• To Measure the Texture of Expanded Flap with VISIA scanner

  baseline and 12 weeks post treatment

• Occurence of Major Adverse Events

  Up to approximately 12 weeks after study start

Study Arms (2)

Experimental: Fat grafting

EXPERIMENTAL

Autologous fat graft transplantation subdermally to expanded skin.

Procedure: Fat grafting

Control

NO INTERVENTION

Expansion was discontinued until the early signs of complication disappeared.

Interventions

Fat grafting PROCEDURE

In the experimental group, liposuction will be performed and autologous fat graft will be harvest after washing with saline. Patients will receive autologous fat graft transplantation subdermally to expanded skin.

Experimental: Fat grafting

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Expanding skin donor site at the face, neck, anterior chest wall, abdominal wall or back;
• Implanted silicone expander of 50 to 800 ml in size;
• History of deterioration in the expanded skin texture that did not improve after the inflation procedure was suspended for more than 2 weeks;
• Persistent high level of expander internal pressure;
• Need for further skin expansion;

You may not qualify if:

• Evidence of infection, ischemia, ulcer or other pathological changes within the targeting area which defined as not suitable for expansion; or history of delayed healing, radiational therapy;
• Rupture of expanded skin, expander exposure;
• Significant renal, cardiovascular, hepatic and psychiatric diseases;
• Significant medical diseases or infection (including but not limited to the carrier of hepatitis B virus or HIV);
• BMI less than 17 or insufficient subcutaneous fat;
• History of any hematological disease, including leukopenia , thrombocytopenia, or thrombocytosis;
• History of allogenic bone marrow transplantation;
• Pregnant or lactating woman;
• Long history of smoking;
• Evidence of malignant diseases or unwillingness to participate

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai Ninth People's Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Cicatrix; Nevus

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nevi and Melanomas; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of plastic and reconstructive surgery department

Study Record Dates

• First Submitted: June 5, 2016
• First Posted: June 22, 2016
• Study Start: January 1, 2011
• Primary Completion: March 1, 2016
• Study Completion: May 1, 2016
• Last Updated: June 22, 2016

Record last verified: 2016-06

Locations

CN (1)