Nanofat on Wound Healing and Scar Formation (NFWHSF)
Primary Purpose
Scars, Delayed Wound Healing, Hypertrophic Scar
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nanofat injection
Sponsored by
About this trial
This is an interventional treatment trial for Scars focused on measuring adipose derived stem cells, stromal vascular fraction, wound healing, scar formation, donor site morbidity, nanofat
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intradermal Nanofat
Control
Arm Description
This side of the scar received intradermal injection of nanofat during the closure of the donor site.
This side of the scar received no injection.
Outcomes
Primary Outcome Measures
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
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.
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.
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).
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.
Rate of adverse events
Registration of the rate of adverse events appearing at the abdominal wound/abdominal scar
Secondary Outcome Measures
Full Information
NCT ID
NCT03850119
First Posted
February 18, 2019
Last Updated
February 20, 2019
Sponsor
Universitair Ziekenhuis Brussel
1. Study Identification
Unique Protocol Identification Number
NCT03850119
Brief Title
Nanofat on Wound Healing and Scar Formation
Acronym
NFWHSF
Official Title
Nanofat on Wound Healing and Scar Formation: a Randomized, Split-scar, Double Blind Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Anticipated)
Primary Completion Date
September 1, 2021 (Anticipated)
Study Completion Date
March 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitair Ziekenhuis Brussel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will evaluate the effectiveness and safety of intradermal injection of Nanofat on wound healing and scar formation.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scars, Delayed Wound Healing, Hypertrophic Scar, Post Inflammatory Hyperpigmentation, Donor Site Complication
Keywords
adipose derived stem cells, stromal vascular fraction, wound healing, scar formation, donor site morbidity, nanofat
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
monocentric randomized controlled double-blinded prospective interventional study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Patient, investigator, outcome assessor will be blinded for which side of the scar was treated and which was a control. Only the surgeon, who will not be involved in the assessment, will not be blinded.
Allocation
Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intradermal Nanofat
Arm Type
Experimental
Arm Description
This side of the scar received intradermal injection of nanofat during the closure of the donor site.
Arm Title
Control
Arm Type
No Intervention
Arm Description
This side of the scar received no injection.
Intervention Type
Procedure
Intervention Name(s)
Nanofat injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical outcome of the abdominal scar by the use of Patient and Observer Scar Assessment Scale
Description
The abdominal scar will be evaluated clinically by the patient and observer scar assessment scale, starting from one month after the surgery
Time Frame
one year
Title
Clinical assessment of the time to healing of the abdominal wound
Description
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.
Time Frame
one month
Title
Evaluation of histological parameters on tissue biopsy from both sides of the abdominal scar.
Description
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.
Time Frame
six months
Title
Pigmentation Index of the two sides of the scar, measured with a Mexameter
Description
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).
Time Frame
one year
Title
Patient satisfaction of abdominal scar appearance measured by a Visual Analog Scale
Description
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.
Time Frame
one year
Title
Rate of adverse events
Description
Registration of the rate of adverse events appearing at the abdominal wound/abdominal scar
Time Frame
One year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Moustapha Hamdi, MD, PhD
Phone
+ 32 24749400
Email
moustapha.hamdi@uzbrussel.be
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa E Ramaut, MD
Phone
+ 32 484 15 89 01
Email
ramaut.lisa@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moustapha Hamdi, MD,PhD
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Nanofat on Wound Healing and Scar Formation
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