Lipofilling for Healing of Chronic Wounds
- Conditions
- Wound Healing Disorder
- Interventions
- Other: Lipofilling (sublesional fat grafting)
- Registration Number
- NCT05509673
- Lead Sponsor
- University of Witten/Herdecke
- Brief Summary
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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention group Lipofilling (sublesional fat grafting) The intervention group received a fat grafting under the wound bed and into the wound edges.
- Primary Outcome Measures
Name Time Method Reduction of wound area 14 days and 2 month The reduction of the wound area from intervention to 14 days and 2 month post-intervention
- Secondary Outcome Measures
Name Time Method Bacterial contamination wound 3 weeks Wound swabs were taken pre intervention and on days 7, 14 and 21 after intervention
Pain wound 2 month Subjective pain level of the patient in the area of the wound, measured by the visual analogue scale pre and post intervention