Nanofat on Wound Healing and Scar Formation

Hypertrophic Scar Clinical Trial

— NFWHSF  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03850119
• Other study ID #: 2019-044
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: March 1, 2022

Study information

• Verified date: February 2019
• Source: Universitair Ziekenhuis Brussel
• Contact: Moustapha Hamdi, MD, PhD
• Phone: + 32 24749400
• Email: moustapha.hamdi[@]uzbrussel.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: March 1, 2022
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cicatrix
• Cicatrix, Hypertrophic
• Delayed Wound Healing
• Donor Site Complication
• Hyperpigmentation
• Hypertrophic Scar
• Hypertrophy
• Post Inflammatory Hyperpigmentation
• Scars
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Rate of adverse events	Registration of the rate of adverse events appearing at the abdominal wound/abdominal scar	One year