Trial Outcomes & Findings for StrataGraft® Skin Tissue as an Alternative to Autografting Deep Partial-Thickness Burns (NCT NCT01437852)
NCT ID: NCT01437852
Last Updated: 2019-10-16
Results Overview
Determination of complete wound closure of both treatment sites was evaluated at 3 months.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
3 months
Results posted on
2019-10-16
Participant Flow
The study evaluated the safety and efficacy of StrataGraft skin tissue in promoting the healing of deep partial-thickness burns. Subjects had surgical excision and placement of StrataGraft skin tissue and autograft. The trial was conducted at six clinical sites throughout the United States.
All subjects were treated with both StrataGraft skin tissue and autograft as part of the intrapatient comparator design. Two comparable excised areas of deep partial-thickness burn per subject were randomized to receive a single application of autograft or StrataGraft skin tissue.
Participant milestones
| Measure |
StrataGraft Skin Tissue : Autograft
Two comparable deep partial-thickness burns were excised and randomized to receive StrataGraft skin tissue or autograft.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
Received StrataGraft Skin Tissue
|
30
|
|
Overall Study
Received Autograft
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
StrataGraft® Skin Tissue as an Alternative to Autografting Deep Partial-Thickness Burns
Baseline characteristics by cohort
| Measure |
StrataGraft Skin Tissue : Autograft
n=30 Participants
Two comparable deep partial-thickness burns were excised and randomized to receive StrataGraft skin tissue or autograft.
|
|---|---|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Age, Continuous
|
41.0 years
STANDARD_DEVIATION 12.1 • n=93 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=93 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Intent-to-Treat (ITT) Population consisted of all participants who received any amount of StrataGraft skin tissue, regardless of follow-up status. Participants with available data were analyzed.
Determination of complete wound closure of both treatment sites was evaluated at 3 months.
Outcome measures
| Measure |
StrataGraft Skin Tissue
n=29 Participants
StrataGraft skin tissue is a fully-differentiated tissue which exhibits barrier function comparable to that of intact human skin. StrataGraft consists of an epidermal layer of fully-stratified human keratinocytes growing on a dermal layer which is comprised of human fibroblasts embedded in a collagen matrix. StrataGraft skin tissue is a tough, suturable, meshable tissue product that is manufactured with a surface area of 44 cm2. StrataGraft tissue is not intended to be a patient-specific product but rather to provide an allogeneic skin substitute which reproduces many of the structural and biological properties of normal human skin and is anticipated to serve as a biological wound dressing.
|
Autograft
n=29 Participants
The current standard of care for the management of severe burns and other skin trauma is excision of the necrotic tissue followed by autografting.
|
|---|---|---|
|
Number of Participants With Wound Closure of the Treatment Sites at Three Months
|
29 Participants
|
29 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: ITT Population - consisted of all participants who received any amount of StrataGraft skin tissue, regardless of follow-up status.
The percentage of the treatment site area initially covered with StrataGraft tissue that required autograft by day 28 was determined.
Outcome measures
| Measure |
StrataGraft Skin Tissue
n=30 Participants
StrataGraft skin tissue is a fully-differentiated tissue which exhibits barrier function comparable to that of intact human skin. StrataGraft consists of an epidermal layer of fully-stratified human keratinocytes growing on a dermal layer which is comprised of human fibroblasts embedded in a collagen matrix. StrataGraft skin tissue is a tough, suturable, meshable tissue product that is manufactured with a surface area of 44 cm2. StrataGraft tissue is not intended to be a patient-specific product but rather to provide an allogeneic skin substitute which reproduces many of the structural and biological properties of normal human skin and is anticipated to serve as a biological wound dressing.
|
Autograft
The current standard of care for the management of severe burns and other skin trauma is excision of the necrotic tissue followed by autografting.
|
|---|---|---|
|
Percent Area of the StrataGraft Treatment Site Requiring Autografting by Day 28
|
0 Percentage of area
Interval 0.0 to 100.0
|
—
|
Adverse Events
StrataGraft Skin Tissue : Autograft
Serious events: 6 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
StrataGraft Skin Tissue : Autograft
n=30 participants at risk
Two comparable deep partial-thickness burns were excised and randomized to receive StrataGraft skin tissue or autograft.
|
|---|---|
|
Infections and infestations
Cellulitis
|
3.3%
1/30 • Number of events 2 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
General disorders
Impaired healing
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Nervous system disorders
Pain
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Infections and infestations
Pneumonia
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Thermal burn
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Transplant failure
|
6.7%
2/30 • Number of events 3 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Vascular disorders
Deep vein thrombosis
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
Other adverse events
| Measure |
StrataGraft Skin Tissue : Autograft
n=30 participants at risk
Two comparable deep partial-thickness burns were excised and randomized to receive StrataGraft skin tissue or autograft.
|
|---|---|
|
Surgical and medical procedures
Wound drainage
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Infections and infestations
Wound infection, Staphylococcal
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
6.7%
2/30 • Number of events 2 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Infections and infestations
Abscess, limb
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Blood and lymphatic system disorders
Anaemia
|
6.7%
2/30 • Number of events 2 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Psychiatric disorders
Anxiety
|
10.0%
3/30 • Number of events 3 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
3/30 • Number of events 3 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Blister
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Cardiac disorders
Cardiac failure, congestive
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Cephalohematoma
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
General disorders
Chest pain
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
General disorders
Chills
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Gastrointestinal disorders
Constipation
|
3.3%
1/30 • Number of events 2 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Eye disorders
Corneal neovascularization
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Surgical and medical procedures
Debridement
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Nervous system disorders
Dizziness
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
2/30 • Number of events 2 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Excoriation
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Eye disorders
Eyelid oedema
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Metabolism and nutrition disorders
Fluid overload
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Infections and infestations
Fungal infection
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Infections and infestations
Gastroenteritis
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Infections and infestations
Gastrointestinal infection
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Immune system disorders
Gout
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Graft complication
|
6.7%
2/30 • Number of events 2 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Graft infection
|
6.7%
2/30 • Number of events 2 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Nervous system disorders
Headache
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Gastrointestinal disorders
Haemorrhoids
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Infections and infestations
Herpes simplex
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Nervous system disorders
Hyperaesthesia
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Metabolism and nutrition disorders
Hypermetabolism
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Vascular disorders
Hypertension
|
10.0%
3/30 • Number of events 3 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Nervous system disorders
Hypoaesthesia
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Vascular disorders
Hypotension
|
6.7%
2/30 • Number of events 3 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.7%
2/30 • Number of events 2 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Gastrointestinal disorders
Ileus
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
General disorders
Impaired healing
|
6.7%
2/30 • Number of events 2 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Infections and infestations
Influenza
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Gastrointestinal disorders
Intestinal functional disorder
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Joint contracture
|
6.7%
2/30 • Number of events 2 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Joint injury
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Infections and infestations
Keratitis, fungal
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Laceration
|
6.7%
2/30 • Number of events 2 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Muscule contracture
|
3.3%
1/30 • Number of events 2 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Infections and infestations
Nasopharyngitis
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Gastrointestinal disorders
Nausea
|
6.7%
2/30 • Number of events 2 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Nervous system disorders
Neuralgia
|
10.0%
3/30 • Number of events 3 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.7%
2/30 • Number of events 2 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
General disorders
Pain
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
2/30 • Number of events 2 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Nervous system disorders
Paraesthesia
|
3.3%
1/30 • Number of events 2 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Nervous system disorders
Peroneal nerve palsy
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Infections and infestations
Post procedural infection
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Infections and infestations
Prostate infection
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
16.7%
5/30 • Number of events 5 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
General disorders
Pyrexia
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
General disorders
Oedema
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
General disorders
Oedema peripheral
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Red man syndrome
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Renal and urinary disorders
Renal failure, acute
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Immune system disorders
Sarcoidosis
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Nervous system disorders
Sensory disturbance
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Infections and infestations
Sepsis
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Infections and infestations
Sinusitis
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Cardiac disorders
Tachycardia
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Vascular disorders
Thrombophlebitis
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Infections and infestations
Urinary tract infection
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
|
Surgical and medical procedures
Wisdom teeth removal
|
3.3%
1/30 • Number of events 1 • Up to 12 months
All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
|
Additional Information
Mary Lokuta
Stratatech Corporation, a Mallinckrodt Company
Phone: 608-441-8358
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place