Scar Tissue Analysis After Intraoperative Application of Stromal Vascular Fraction Cells Into Suture Line

Katarina Zivec

Status: Unknown

Conditions: Hypertrophic Scar; Wound Heal; Delayed Wound Healing; Scar

Treatments: Procedure: Intradermal stromal vascular fraction injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04238468

SSVF

Details and patient eligibility

About

The study will evaluate the effect of intradermal injection of stromal vascular fraction into suture line on wound healing and scarring.

Full description

Patients undergoing primary or secondary Deep Inferior Epigastric Perforator (DIEP) flap breast reconstruction will be included in this monocentric, randomised, controlled, double-blinded study.

After bilateral flank liposuction, the fat will be processed by a special protocol with enzymatic digestion. Stromal vascular fraction will be isolated and injected intradermally just after wound closure into one site of surgical wound (most lateral 5 cm) at the DIEP flap donor site. The other site of DIEP flap donor site (most lateral 5 cm) will serve as a control. Part of stromal vascular fraction will be analysed by flow cytometry for the viability and cell specification. Ten months after DIEP flap surgery the scars at both sites (control and injected site) will be excised and analysed histologically. At that time photographs will be taken and scars will be analysed by Patient and Observer Assesment Scale (POSAS).

Enrollment: 20 patients

Sex: Female

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• breast cancer patients scheduled for primary or secondary DIEP flap breast reconstruction

Exclusion criteria

• BMI
• age
• immunosuppressive disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups

Intradermal injection of stromal vascular fraction

Experimental group

Description:

Most lateral 5 cm of abdominal donor site will be injected with stromal vascular fraction just after the wound is closed.

Treatment:

Procedure: Intradermal stromal vascular fraction injection

control

No Intervention group

Description:

Most contralateral 5 cm of abdominal donor site will serve as control.