Nanofat on Wound Healing and Scar Formation (NFWHSF)

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

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

Study Overview

• Status: Unknown
• Conditions: Scars; Hypertrophic Scar; Donor Site Complication; Post Inflammatory Hyperpigmentation; Delayed Wound Healing
• Intervention / Treatment: Procedure: Nanofat injection

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.

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Moustapha Hamdi, MD, PhD; Phone Number: + 32 24749400; Email: moustapha.hamdi@uzbrussel.be
• Study Contact Backup: Name: Lisa E Ramaut, MD; Phone Number: + 32 484 15 89 01; Email: ramaut.lisa@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel
• Investigators: Principal Investigator: Moustapha Hamdi, MD,PhD, Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2019
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: February 18, 2019
• First Submitted That Met QC Criteria: February 20, 2019
• First Posted (Actual): February 21, 2019

Study Record Updates

• Last Update Posted (Actual): February 21, 2019
• Last Update Submitted That Met QC Criteria: February 20, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: wound healing; stromal vascular fraction; nanofat; adipose derived stem cells; scar formation; donor site morbidity
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Fibrosis; Pigmentation Disorders; Wounds and Injuries; Cicatrix; Hyperpigmentation; Cicatrix, Hypertrophic
• Other Study ID Numbers: 2019-044

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No