Wound Healing Disorder
Conditions
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)
Interventions
OTHERLipofilling (sublesional fat grafting)
Sponsors
Cologne-Merheim Medical Center (CMMC)
University of Witten/Herdecke
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Digital analysis of wound area is masked
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Bacterial contamination wound | 3 weeks | Wound swabs were taken pre intervention and on days 7, 14 and 21 after intervention |
Outcome results
None listed