NFWHSF: Nanofat on Wound Healing and Scar Formation

Sponsor

Universitair Ziekenhuis Brussel (Other)

Overall Status

Unknown status

CT.gov ID

NCT03850119

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Scars Delayed Wound Healing Hypertrophic Scar Post Inflammatory Hyperpigmentation Donor Site Complication	Procedure: Nanofat injection	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

monocentric randomized controlled double-blinded prospective interventional studymonocentric randomized controlled double-blinded prospective interventional study

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2019

Anticipated Primary Completion Date :

Sep 1, 2021

Anticipated Study Completion Date :

Mar 1, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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.
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.
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).
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.
Rate of adverse events [One year]
Registration of the rate of adverse events appearing at the abdominal wound/abdominal scar