Trials / Unknown
UnknownNCT03850119
Nanofat on Wound Healing and Scar Formation
Nanofat on Wound Healing and Scar Formation: a Randomized, Split-scar, Double Blind Trial
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- Sponsor
- Universitair Ziekenhuis Brussel · Academic / Other
- Sex
- Female
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Accepted
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.
Conditions
- Scars
- Delayed Wound Healing
- Hypertrophic Scar
- Post Inflammatory Hyperpigmentation
- Donor Site Complication
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2019-03-01
- Primary completion
- 2021-09-01
- Completion
- 2022-03-01
- First posted
- 2019-02-21
- Last updated
- 2019-02-21
Source: ClinicalTrials.gov record NCT03850119. Inclusion in this directory is not an endorsement.