Phase 2
N=15
StrataGraft™ Skin Tissue (Human Donor Skin) In The Surgical Management Of Complex Skin Defects
Third Degree Burn · Burns · Wound Infection · Degloving Injury
Bottom Line
View on ClinicalTrials.gov: NCT00618839 ↗Enrolled (actual)
15
Serious AEs
20.0%
Results posted
Sep 2012
Primary outcome: Primary: Percent Autograft Take on Wounds Prepared by StrataGraft™ Skin Tissue. — 97.7; 96.7 Percent Area of Autograft Take (%)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- StrataGraft Skin Tissue (Biological); Cadaver allograft (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stratatech, a Mallinckrodt Company
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Autograft Take on Wounds Prepared by StrataGraft™ Skin Tissue. |
97.7; 96.7 | — |
| SECONDARY Appearance of Allograft Tissues |
1.70; 1.49 | — |
| SECONDARY Viability of Allograft Tissues |
0.567; 0.189 | — |
Summary
This pilot Phase I/II clinical study will be conducted at up to three clinical sites.
This is an open-label, randomized, comparative study with a maximum of fifteen (15) patients, each with skin defects. The patients are intended to undergo sequential surgical procedures involving surgical skin debridement and temporary allogeneic (cadaver skin) grafting at various separate or contiguous wound sites. Patients will be randomized within each wound site to one of two test products: cadaver skin or StrataGraft™ skin tissue.
Eligibility Criteria
Inclusion Criteria
- Patients aged greater than 18 yrs.
- Patients with complex skin defects requiring sequential debridement under anesthesia with temporary biological dressing (allogeneic grafting) prior to autografting
- Full-thickness skin defects
- Informed consent
Exclusion Criteria
- Prisoners
- Pregnant (positive urinary pregnancy in women of child-bearing potential at Visit#1) or lactating females
- Immunosuppressive therapy
- Infection with Human Immunodeficiency Virus
- Venous stasis ulcers of the lower leg
- Diabetic foot ulcers
- Donor site wounds
- Wounds of less than 5% body surface area
- Wounds of the hands, face, and feet (although such wound surface areas can be counted toward total injured BSA)
- Prior entry into this study
- Expected survival of less than 3 months
- Concomitant processes sustained contemporaneously with the dermal injury (e.g., inhalational injury requiring ventilation, electrical injury with cardiac damage or arrhythmia, sepsis, other serious or unstabilized organ damage from trauma, etc.)
- Use of an investigational agent within 30 days
- Active malignancy
- Clinical evidence of malnutrition
- Clinically significant renal, hepatic, cardiac, pulmonary, or neurological impairments
Data sourced from ClinicalTrials.gov (NCT00618839). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.