Nanofat on Wound Healing and Scar Formation

NCT03850119 | Unknown DMC

• 1 other identifier: 2019-044
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Intradermal Nanofat

EXPERIMENTAL

This side of the scar received intradermal injection of nanofat during the closure of the donor site.

Procedure: Nanofat injection

Control

NO INTERVENTION

This side of the scar received no injection.

Interventions

Nanofat injection PROCEDURE

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.

Intradermal Nanofat

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- scheduled for DIEP-flap breast reconstruction surgery at our department

You may not qualify if:

• smokers
• use of cortisone or other immunsuppressants
• diabetes mellitus type 1 or 2
• age
• connective tissue disease

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

MeSH Terms

Conditions

Cicatrix; Cicatrix, Hypertrophic; Hyperpigmentation

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Moustapha Hamdi, MD,PhD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Moustapha Hamdi, MD, PhD

CONTACT

+ 32 24749400; moustapha.hamdi@uzbrussel.be

Lisa E Ramaut, MD

CONTACT

+ 32 484 15 89 01; ramaut.lisa@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department Plastic and Reconstructive surgery

Model Details: monocentric randomized controlled double-blinded prospective interventional study

Study Record Dates

• First Submitted: February 18, 2019
• First Posted: February 21, 2019
• Study Start: March 1, 2019
• Primary Completion: September 1, 2021
• Study Completion: March 1, 2022
• Last Updated: February 21, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share