Limb Salvage Through Tissue Engineering: A Novel Treatment Modality Using Dehydrated Human Amnion/Chorion Membrane
Description:
53 patients ages 18 and over , presenting with wounds with exposed critical structures (bone
and/or tendon) will be enrolled in the study and randomized into one of two groups. 21
patients will be in the standard treatment group (Flap based reconstruction) and 32 patients
will be in the dHACM (EpiFix) + skin grafting treatment group (Experimental). Exclusion
criteria includes exposed implanted hardware (surgical plates), anticipated need for future
surgical procedures through the same wound, wounds resulting from surgical removal of
malignancy, and patients who are not free flap candidates.
Data will be collected upon enrollment including:
Background and demographic information Wound size and severity Pain level Medication use
Photographs of wound
Flap Reconstruction group (Standard of Care):
Patients in this group will have any dead, damaged or infected tissue removed from the wound
and a negative pressure wound dressing will be applied until the wound is clean and adequate
for flap reconstruction. Following flap reconstruction, patients typically require a 36-48
hour intensive care unit admission for flap monitoring and 5 days to bed rest to allow for
proper healing. If the flap is successful, a dangle protocol will occur until patient
increases the dependent position. Once the dangle protocol is completed, patients may require
inpatient physical/occupational therapy prior to discharge from the hospital. If patient is
not healing the physician may discuss other treatment options including crossing over to the
EpiFix arm or amputation.
EpiFix and Skin Graft group:
Patients in this group will have any dead, damaged or infected tissue removed from wound.
Once it is free from infection, a thin tissue (EpiFix) will be applied directly to the open
wound. This will be covered by sterile wound dressing. After approximately 5-7 days the wound
will be assessed for suitability of split thickness skin grafting. If adequately healed, skin
grafting will be performed. After 5 days, the graft will be evaluated and if successful, the
patient will be discharged home or to a rehab facility. If the wounds are not adequate for
skin grafting, additional damaged tissue will removed and EpiFix will be placed until the
wound is suitable for grafting. If you do not heal sufficiently the physician will discuss
other treatment options including cross over to the standard of care Free Flap or amputation.
Study staff will evaluate the wound twice a week for the first 2 weeks, then once a week
until 6 weeks. At this point, the patient will be followed every 4 weeks up to 22 weeks.
Visits to the clinic will include wound measurements, photos, pain scale and evaluation of
any infection.
Condition:
Wounds
Treatment:
Dehydrated Human Amnion/Chorion Membrane
Start Date:
February 2016
Sponsor:
Louisiana State University Health Sciences Center in New Orleans
For More Information:
https://clinicaltrials.gov/show/NCT03521258