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Nanofat on Wound Healing and Scar Formation (NFWHSF)

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ClinicalTrials.gov Identifier: NCT03850119
Recruitment Status : Not yet recruiting
First Posted : February 21, 2019
Last Update Posted : February 21, 2019
Sponsor:
Information provided by (Responsible Party):
Moustapha Hamdi, Universitair Ziekenhuis Brussel

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

Condition or disease Intervention/treatment Phase
Scars Delayed Wound Healing Hypertrophic Scar Post Inflammatory Hyperpigmentation Donor Site Complication Procedure: Nanofat injection Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: monocentric randomized controlled double-blinded prospective interventional study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes 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.
Primary Purpose: Treatment
Official Title: Nanofat on Wound Healing and Scar Formation: a Randomized, Split-scar, Double Blind Trial
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : March 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intradermal Nanofat
This side of the scar received intradermal injection of nanofat during the closure of the donor site.
Procedure: 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.

No Intervention: Control
This side of the scar received no injection.



Primary Outcome Measures :
  1. Clinical outcome of the abdominal scar by the use of Patient and Observer Scar Assessment Scale [ Time Frame: one year ]
    The abdominal scar will be evaluated clinically by the patient and observer scar assessment scale, starting from one month after the surgery

  2. Clinical assessment of the time to healing of the abdominal wound [ Time Frame: one month ]
    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.

  3. Evaluation of histological parameters on tissue biopsy from both sides of the abdominal scar. [ Time Frame: six months ]
    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.

  4. Pigmentation Index of the two sides of the scar, measured with a Mexameter [ Time Frame: one year ]
    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).

  5. Patient satisfaction of abdominal scar appearance measured by a Visual Analog Scale [ Time Frame: one year ]
    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.

  6. Rate of adverse events [ Time Frame: One year ]
    Registration of the rate of adverse events appearing at the abdominal wound/abdominal scar



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03850119


Contacts
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Contact: Moustapha Hamdi, MD, PhD + 32 24749400 moustapha.hamdi@uzbrussel.be
Contact: Lisa E Ramaut, MD + 32 484 15 89 01 ramaut.lisa@gmail.com

Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Investigators
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Principal Investigator: Moustapha Hamdi, MD,PhD Universitair Ziekenhuis Brussel

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Responsible Party: Moustapha Hamdi, Head of department Plastic and Reconstructive surgery, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT03850119     History of Changes
Other Study ID Numbers: 2019-044
First Posted: February 21, 2019    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Moustapha Hamdi, Universitair Ziekenhuis Brussel:
adipose derived stem cells
stromal vascular fraction
wound healing
scar formation
donor site morbidity
nanofat

Additional relevant MeSH terms:
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Wounds and Injuries
Cicatrix
Hypertrophy
Cicatrix, Hypertrophic
Hyperpigmentation
Fibrosis
Pathologic Processes
Pathological Conditions, Anatomical
Pigmentation Disorders
Skin Diseases