Nanofat on Wound Healing and Scar Formation (NFWHSF)

Universitair Ziekenhuis Brussel

Status: Unknown

Conditions: Scars; Donor Site Complication; Post Inflammatory Hyperpigmentation; Hypertrophic Scar; Delayed Wound Healing

Treatments: Procedure: Nanofat injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03850119

2019-044

Details and patient eligibility

About

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

Full 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.

Enrollment: 15 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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15 participants in 2 patient groups

Intradermal Nanofat

Experimental group

Description:

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

Treatment:

Procedure: Nanofat injection

Control

No Intervention group

Description:

This side of the scar received no injection.