Clinical trial · Interventional
The Effects of Autologous Fat Transfer on Preventing Expanded Skin From Expansion Failure
NCT02809001CI-TRIAL-00022669completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nevus | Nevus | ONTOLOGY_EXACT | 0.98 |
| Scar | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fat grafting | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental: Fat grafting
- description
- Autologous fat graft transplantation subdermally to expanded skin.
- interventionNames
- Procedure: Fat grafting
- type
- NO_INTERVENTION
- label
- Control
- description
- Expansion was discontinued until the early signs of complication disappeared.
Primary outcomes (2)
- measure
- To Measure the Change in Expansion Volume
- timeFrame
- Change from baseline volume at 12 weeks
- description
- Record the volume(ml) of each expander
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * 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; Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.