Lipofilling for Healing of Chronic Wounds

University of Witten/Herdecke

Status: Completed

Conditions: Wound Healing Disorder

Treatments: Other: Lipofilling (sublesional fat grafting)

Study type: Interventional

Funder types: Other

Identifiers

NCT05509673

2010-001

Details and patient eligibility

About

Chronic wounds remain a therapeutic and financial challenge for physicians and the health care systems. Innovative, cheap and effective treatment methods would be of immense value. The sublesional fat grafting could be such treatment, although the effectiveness and safety have not been assessed in large randomized clinical trials. The aim of this trial was to analyse the effect of adipose tissue on the healing of chronic lower leg wounds. For this purpose, the wounds were surgically cleaned (wound debridement) and then fat was suctioned out from the stomach or thighs and then injected into the edges of the wound and under the wounds. The wounds are covered with a foam dressing that is changed every 3-4 days. There are controls on days 3, 7, 14 and 21 after the intervention and a follow-up examination 2 months after the intervention. The primary objective is the reduction of the wound area 14 days and 2 month after intervention. Secondary objectives are pain level of the wound, bacterial colonialisation of the wound and analysis of the grafted fat tissue (ammount of mesenchymal stem cells)

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with leg ulcers of any origin (venous, arterial, mixed arterial-venous, diabetogenic, compressive)
• Age of ulcer > 6 weeks
• Ulcer size >= 1 cm (minimum diameter)
• Ulcer / wound with complete destruction of the epidermis (including basement membrane)
• Patient age > 18 years
• Patient Consent

Exclusion criteria

• Pregnancy
• Exposed tendons, ligaments, or bone if maximum diameter > 2 mm
• Ulcer size > 10 cm
• Immediately preceding vacuum bandage therapy (< 2 weeks)
• Possibilities for correcting the cause of the ulcer

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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34 participants in 2 patient groups

Intervention group

Experimental group

Description:

The intervention group received a fat grafting under the wound bed and into the wound edges.

Treatment:

Other: Lipofilling (sublesional fat grafting)

Control group

No Intervention group

Description:

The control group received an injection of saline solution (0.9%) under the wound bed and into the wound edges.