Nanofat on Wound Healing and Scar Formation

Not Applicable

• Conditions: Scars; Delayed Wound Healing; Hypertrophic Scar; Post Inflammatory Hyperpigmentation; Donor Site Complication
• Interventions: Procedure: Nanofat injection

• Registration Number: NCT03850119
• Lead Sponsor: Universitair Ziekenhuis Brussel

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.

Study Timeline

• Status Verified: 2019-02
• Study First Submitted: 2019-02-18
• Study First Submitted QC: 2019-02-20
• Last Update Submitted: 2019-02-20
• Study First Posted: 2019-02-21
• Last Update Posted: 2019-02-21
• Study Start: 2019-03-01
• Primary Completion: 2021-09-01
• Study Completion: 2022-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intradermal Nanofat	Nanofat injection	This side of the scar received intradermal injection of nanofat during the closure of the donor site.

Primary Outcome Measures

Name	Time	Method
Clinical outcome of the abdominal scar by the use of Patient and Observer Scar Assessment Scale	one year	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	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.
Patient satisfaction of abdominal scar appearance measured by a Visual Analog Scale	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.
Evaluation of histological parameters on tissue biopsy from both sides of the abdominal scar.	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.
Rate of adverse events	One year	Registration of the rate of adverse events appearing at the abdominal wound/abdominal scar
Pigmentation Index of the two sides of the scar, measured with a Mexameter	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).