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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
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

    First Posted
    February 18, 2019
    Last Updated
    February 20, 2019
    Sponsor
    Universitair Ziekenhuis Brussel
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    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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