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Lipofilling for Healing of Chronic Wounds

NCT05509673 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2022-08-22

No results posted yet for this study

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

Interventions

OTHER

Lipofilling (sublesional fat grafting)

Sponsors & Collaborators

  • Cologne-Merheim Medical Center (CMMC)

    collaborator UNKNOWN

  • University of Witten/Herdecke

    lead OTHER

Principal Investigators

  • Oliver C Thamm, MD, PhD · University of Witten/Herdecke

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-29
Primary Completion
2016-11-30
Completion
2017-03-06

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05509673 on ClinicalTrials.gov