Nanofat on Wound Healing and Scar Formation

Study Overview
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Brief Summary
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This study will evaluate the effectiveness and safety of intradermal injection of Nanofat on wound healing and scar formation.

Detailed Description
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In this monocentric, randomized, controlled, double-blinded prospective interventional study, twenty patients will be included. Each patient will be his/her own control. 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.

Official Title
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Nanofat on Wound Healing and Scar Formation: a Randomized, Split-scar, Double Blind Trial

Conditions
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Scars, Delayed Wound Healing, Hypertrophic Scar, Post Inflammatory Hyperpigmentation, Donor Site Complication

Intervention / Treatment
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* Procedure: Nanofat injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - scheduled for DIEP-flap breast reconstruction surgery at our department Exclusion Criteria: smokers use of cortisone or other immunsuppressants diabetes mellitus type 1 or 2 age connective tissue disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: monocentric randomized controlled double-blinded prospective interventional study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intradermal Nanofat<br>This side of the scar received intradermal injection of nanofat during the closure of the donor site. | Procedure: Nanofat injection<br>* 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.<br>|
| No Intervention: Control<br>This side of the scar received no injection. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcome of the abdominal scar by the use of Patient and Observer Scar Assessment Scale | The abdominal scar will be evaluated clinically by the patient and observer scar assessment scale, starting from one month after the surgery | one year | 
| Clinical assessment of the time to healing of the abdominal wound | The time for the abdominal wound to heal will be registered. Wound healing is considered a closed and non-dehiscent wound witout signs of inflammation or infection. | one month | 
| Evaluation of histological parameters on tissue biopsy from both sides of the abdominal scar. | Evaluation of the histological differences of the treatment arm vs. control, by evaluating scar properties on tissue biopsy. Scar thickness, collagen arrangement and angiogenesis will be evaluated. | six months | 
| Pigmentation Index of the two sides of the scar, measured with a Mexameter | Evaluation of the Pigmentation Index difference in the treatment arm vs. control arm will be measured by the use of a mexameter, starting from one month after the procedure (after wound healing is complete). | one year | 
| Patient satisfaction of abdominal scar appearance measured by a Visual Analog Scale | Evaluation of patient satisfaction over the entire course of the study by filling in a Visual Analog Scale, with 1 being very unsatisfied and 10 being very satisfied. | one year | 
| Rate of adverse events | Registration of the rate of adverse events appearing at the abdominal wound/abdominal scar | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adipose derived stem cells, stromal vascular fraction, wound healing, scar formation, donor site morbidity, nanofat