LeucoPatch® in Nonhealing Wounds With Exposed Bone or Tendon Study — LiNWEX  

Wound Healing Delayed Clinical Trial

Official title: LeucoPatch® in Nonhealing Wounds With Exposed Bone or Tendon Study

Status Withdrawn

Clinical Trial Summary

The trial compare the healing rate of chronic wounds with exposed tendon or bone ('problematic wound area') with LeucoPatch® treatment for 8 up to 16 weeks in addition to usual care versus usual care.

The healing rate will be measured as relative reduction of 'problematic wound area' at 8 weeks

Clinical Trial Description

A certain subpopulation of plastic surgery patients has chronic, non-healing wounds with exposed bone or tendon e.g. located on the scalp or extremities. The chronic non-healing wounds are characterized by no significant wound area reduction within 4 weeks of standard wound treatment. Standard wound treatment includes mechanical or sharp serial debridement and low pressure irrigation for cleansing and wound dressings ensuring moist wound healing. Exposed bone or tendon in a chronic wound can be described as a potentially 'problematic wound area', since the healing by sound granulation tissue from the soft tissue sides of the wound to cover the problematic wound area is often reduced or absent.

The subpopulation is characterized by either referral from other specialties with non-healing wounds of various etiologies and no or limited options of medical, surgical, or reconstructive plastic surgery procedures to treat the wounds; or the wounds are a consequence of previous reconstructive procedures with unsuccessful outcome and no or limited options of further reconstructive surgery. This group of patients often needs wound treatment for a very long period (months-years) to heal, in spite of best practice standards of wound treatment. Treatment with xenogeneic acellular dermal matrixes and autologous full- or split-thickness skin grafts may be an option, but it often requires general anesthesia and a 2-staged approach. The LeucoPatch may be a new solution in wound treatment, which can be used in the outpatient clinic, to promote faster healing in patients with chronic, non-healing wounds with exposed bone or tendon ;

Related Conditions & MeSH terms

• Wound Healing Delayed
• Wounds and Injuries

• NCT number: NCT03370055
• Study type: Interventional
• Source: Nordsjaellands Hospital
• Status: Withdrawn
• Phase: N/A
• Start date: November 2, 2017
• Completion date: May 1, 2020