NCT03370055

LeucoPatch® in Nonhealing Wounds With Exposed Bone or Tendon Study

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Jais Oliver Berg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• Wound Healing Delayed

Interventions

Type	Name	Description
DEVICE	LeucoPatch®	LeucoPatch® is an elastic membrane produced by the patients own venous blood by centrifugation, and one or two is placed on the wound once a week The LeucoPatch® consist of the fibrin Leucocytes and growth factors from the patients own blood
OTHER	Control,	Usual wound care in a specialized clinic

Timeline

• Start date: 2017-11-02
• Primary completion: 2019-12-31
• Completion: 2020-05-01
• First posted: 2017-12-12
• Last updated: 2020-11-18

Locations

1 site across 1 country: Denmark