Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
15 participants
INTERVENTIONAL
2019-03-01
2022-03-01
Brief Summary
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Detailed Description
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Patients undergoing DIEPflap breast reconstruction will be included in this study. During the surgery, the abdominal incision will be divided in two equal sides with the umbilicus as midline reference. The sides will be randomized in a treatment side and control side. The treatment side will receive intradermal nanofat injections after the subcutaneous and right before the intradermal sutures.
The patient and investigators will be blinded for the treatment protocol. The effects on wound healing, adverse events, scar formation and pigmentation will be evaluated up to one year after the surgery.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Intradermal Nanofat
This side of the scar received intradermal injection of nanofat during the closure of the donor site.
Nanofat injection
Lipoaspirate, harvested during the surgery, is centrifuged for 1 minute at 2000 rpm to discard infiltration fluid. The residual fat is passed back and forth between two 10cc syringes interlocked with Tulip connecting pieces (2.4, 1.4 and 1.2 diameter, each 10 passes for a total of 30 passes). This is injected intradermally before the intradermal sutures are placed. The donor site is always entirely sutured (both sides) by the same person.
Control
This side of the scar received no injection.
No interventions assigned to this group
Interventions
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Nanofat injection
Lipoaspirate, harvested during the surgery, is centrifuged for 1 minute at 2000 rpm to discard infiltration fluid. The residual fat is passed back and forth between two 10cc syringes interlocked with Tulip connecting pieces (2.4, 1.4 and 1.2 diameter, each 10 passes for a total of 30 passes). This is injected intradermally before the intradermal sutures are placed. The donor site is always entirely sutured (both sides) by the same person.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* use of cortisone or other immunsuppressants
* diabetes mellitus type 1 or 2
* age
* connective tissue disease
18 Years
70 Years
FEMALE
Yes
Sponsors
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Universitair Ziekenhuis Brussel
OTHER
Responsible Party
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Moustapha Hamdi
Head of department Plastic and Reconstructive surgery
Principal Investigators
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Moustapha Hamdi, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Universitair Ziekenhuis Brussel
Central Contacts
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Other Identifiers
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2019-044
Identifier Type: -
Identifier Source: org_study_id
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