Lipofilling for Healing of Chronic Wounds

NCT ID: NCT05509673

Last Updated: 2022-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-29
• Study Completion Date: 2017-03-06

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)

Conditions

Wound Healing Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention group

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

Group Type: EXPERIMENTAL

Lipofilling (sublesional fat grafting)

Intervention Type: OTHER

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Lipofilling (sublesional fat grafting)

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cologne-Merheim Medical Center (CMMC)

UNKNOWN

Sponsor Role: collaborator

University of Witten/Herdecke

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Oliver C Thamm, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Witten/Herdecke

Other Identifiers

2010-001

Identifier Type: -

Identifier Source: org_study_id