FORCEREPAIR - A Wound Exudate Investigation

Launched by BISPEBJERG HOSPITAL · Oct 26, 2023

Keywords

ClinConnect Summary

The FORCEREPAIR trial is an important study looking at how wounds, specifically venous leg ulcers, heal over time. Researchers will collect samples of the fluid that comes from these wounds, known as wound exudate, from twenty adults who have been diagnosed with venous leg ulcers. By examining these samples and monitoring the size of the wounds during four visits, the study aims to understand the healing process better and how bacteria might affect it.

To participate, you need to be an adult over 18 years old with a confirmed diagnosis of a venous leg ulcer that meets specific characteristics, such as swelling and discoloration. You also need to be able to understand Danish and agree to follow the study protocol. If you join the study, you can expect to visit the research site several times for evaluations and sample collections, which will help researchers gain valuable insights into wound healing. It's important to note that certain conditions, like having a wound that goes down to the bone or known cancer in the wound, may prevent someone from participating.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adults fulfilling all inclusion criteria
• • Age \>18 years
• • Venous leg ulcer diagnosis and classic characteristics (localisation, varicose veins, brown-orange hyperpigmentation, leg oedema, stasis dermatitis, atrophie blanche or lipodermatosclerosis) verified by a wound expert (if in doubt venous doppler will be used for verification)
• • Wound Area equal to or above 1 cm2 (measured with a ruler length x width)
• • Patient can understand Danish
• • Patient can comply with protocol
• • Patient is fully informed about the study and has given informed consent
• Exclusion Criteria:
• • Venous leg ulcer with communication to bone
• • Known or suspected cancer in the wound
• • Allergies towards products used in the study, e.g. polyurethane foam and tegaderm
• • Dementia
• • Judgement by the investigator that the patient is not suited for study participation