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Trial record 2 of 5 for:    stratagraft

StrataGraft® Skin Tissue as an Alternative to Autografting Deep Partial-Thickness Burns

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ClinicalTrials.gov Identifier: NCT01437852
Recruitment Status : Completed
First Posted : September 21, 2011
Results First Posted : December 13, 2018
Last Update Posted : October 16, 2019
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt ( Stratatech, a Mallinckrodt Company )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Skin Wound
Burns
Trauma-related Wound
Intervention Biological: StrataGraft Skin Tissue
Enrollment 30
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title StrataGraft Skin Tissue : Autograft
Hide Arm/Group Description Two comparable deep partial-thickness burns were excised and randomized to receive StrataGraft skin tissue or autograft.
Period Title: Overall Study
Started 30
Received StrataGraft Skin Tissue 30
Received Autograft 30
Completed 30
Not Completed 0
Arm/Group Title StrataGraft Skin Tissue : Autograft
Hide Arm/Group Description Two comparable deep partial-thickness burns were excised and randomized to receive StrataGraft skin tissue or autograft.
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
<=18 years
0
   0.0%
Between 18 and 65 years
30
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
41.0  (12.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
9
  30.0%
Male
21
  70.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
1.Primary Outcome
Title Number of Participants With Wound Closure of the Treatment Sites at Three Months
Hide Description Determination of complete wound closure of both treatment sites was evaluated at 3 months.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title StrataGraft Skin Tissue Autograft
Hide Arm/Group Description:
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.
The current standard of care for the management of severe burns and other skin trauma is excision of the necrotic tissue followed by autografting.
Overall Number of Participants Analyzed 29 29
Measure Type: Count of Participants
Unit of Measure: Participants
29
 100.0%
29
 100.0%
2.Primary Outcome
Title Percent Area of the StrataGraft Treatment Site Requiring Autografting by Day 28
Hide Description The percentage of the treatment site area initially covered with StrataGraft tissue that required autograft by day 28 was determined.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population - consisted of all participants who received any amount of StrataGraft skin tissue, regardless of follow-up status.
Arm/Group Title StrataGraft Skin Tissue
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 30
Median (Full Range)
Unit of Measure: Percentage of area
0
(0 to 100)
Time Frame Up to 12 months
Adverse Event Reporting Description All participants who were treated with StrataGraft skin tissue were included in the safety analysis.
 
Arm/Group Title StrataGraft Skin Tissue : Autograft
Hide Arm/Group Description Two comparable deep partial-thickness burns were excised and randomized to receive StrataGraft skin tissue or autograft.
All-Cause Mortality
StrataGraft Skin Tissue : Autograft
Affected / at Risk (%)
Total   0/30 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
StrataGraft Skin Tissue : Autograft
Affected / at Risk (%) # Events
Total   6/30 (20.00%)    
General disorders   
Impaired healing  1 [1]  1/30 (3.33%)  1
Infections and infestations   
Cellulitis  1 [2]  1/30 (3.33%)  2
Pneumonia  1 [2]  1/30 (3.33%)  1
Nervous system disorders   
Pain  1 [2]  1/30 (3.33%)  1
Respiratory, thoracic and mediastinal disorders   
Pulmonary embolism  1 [2]  1/30 (3.33%)  1
Skin and subcutaneous tissue disorders   
Thermal burn  1 [2]  1/30 (3.33%)  1
Transplant failure  1 [2]  2/30 (6.67%)  3
Vascular disorders   
Deep vein thrombosis  1 [2]  1/30 (3.33%)  1
1
Term from vocabulary, MedDRA
Indicates events were collected by systematic assessment
[1]
AE considered possibly related to the StrataGraft skin tissue treatment due to inappropriate selection of full-thickness wound that did not meet study inclusion.
[2]
All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
StrataGraft Skin Tissue : Autograft
Affected / at Risk (%) # Events
Total   27/30 (90.00%)    
Blood and lymphatic system disorders   
Anaemia  1 [1]  2/30 (6.67%)  2
Coagulopathy  1 [1]  1/30 (3.33%)  1
Cardiac disorders   
Cardiac failure, congestive  1 [1]  1/30 (3.33%)  1
Tachycardia  1 [1]  1/30 (3.33%)  1
Eye disorders   
Corneal neovascularization  1 [1]  1/30 (3.33%)  1
Eyelid oedema  1 [1]  1/30 (3.33%)  1
Gastrointestinal disorders   
Constipation  1 [1]  1/30 (3.33%)  2
Dyspepsia  1 [1]  2/30 (6.67%)  2
Haemorrhoids  1 [1]  1/30 (3.33%)  1
Ileus  1 [1]  1/30 (3.33%)  1
Intestinal functional disorder  1 [1]  1/30 (3.33%)  1
Nausea  1 [1]  2/30 (6.67%)  2
General disorders   
Chest pain  1 [1]  1/30 (3.33%)  1
Chills  1 [1]  1/30 (3.33%)  1
Impaired healing  1 [1]  2/30 (6.67%)  2
Pain  1 [1]  1/30 (3.33%)  1
Pyrexia  1 [1]  1/30 (3.33%)  1
Oedema  1 [1]  1/30 (3.33%)  1
Oedema peripheral  1 [1]  1/30 (3.33%)  1
Immune system disorders   
Gout  1 [1]  1/30 (3.33%)  1
Sarcoidosis  1 [1]  1/30 (3.33%)  1
Infections and infestations   
Abscess, limb  1 [1]  1/30 (3.33%)  1
Fungal infection  1 [1]  1/30 (3.33%)  1
Gastroenteritis  1 [1]  1/30 (3.33%)  1
Gastrointestinal infection  1 [1]  1/30 (3.33%)  1
Herpes simplex  1 [1]  1/30 (3.33%)  1
Influenza  1 [1]  1/30 (3.33%)  1
Keratitis, fungal  1 [1]  1/30 (3.33%)  1
Nasopharyngitis  1 [1]  1/30 (3.33%)  1
Post procedural infection  1 [1]  1/30 (3.33%)  1
Prostate infection  1 [1]  1/30 (3.33%)  1
Sepsis  1 [1]  1/30 (3.33%)  1
Sinusitis  1 [1]  1/30 (3.33%)  1
Urinary tract infection  1 [1]  1/30 (3.33%)  1
Wound infection, Staphylococcal  1 [1]  1/30 (3.33%)  1
Injury, poisoning and procedural complications   
Cephalohematoma  1 [1]  1/30 (3.33%)  1
Excoriation  1 [1]  1/30 (3.33%)  1
Graft complication  1 [1]  2/30 (6.67%)  2
Graft infection  1 [1]  2/30 (6.67%)  2
Joint injury  1 [1]  1/30 (3.33%)  1
Laceration  1 [1]  2/30 (6.67%)  2
Procedural pain  1 [1]  1/30 (3.33%)  1
Wound haemorrhage  1 [1]  1/30 (3.33%)  1
Metabolism and nutrition disorders   
Fluid overload  1 [1]  1/30 (3.33%)  1
Hypermetabolism  1 [1]  1/30 (3.33%)  1
Hypoalbuminaemia  1 [1]  1/30 (3.33%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia  1 [1]  3/30 (10.00%)  3
Joint contracture  1 [1]  2/30 (6.67%)  2
Joint swelling  1 [1]  1/30 (3.33%)  1
Muscule contracture  1 [1]  1/30 (3.33%)  2
Pain in extremity  1 [1]  2/30 (6.67%)  2
Nervous system disorders   
Dizziness  1 [1]  1/30 (3.33%)  1
Headache  1 [1]  1/30 (3.33%)  1
Hyperaesthesia  1 [1]  1/30 (3.33%)  1
Hypoaesthesia  1 [1]  1/30 (3.33%)  1
Neuralgia  1 [1]  3/30 (10.00%)  3
Paraesthesia  1 [1]  1/30 (3.33%)  2
Peroneal nerve palsy  1 [1]  1/30 (3.33%)  1
Sensory disturbance  1 [1]  1/30 (3.33%)  1
Psychiatric disorders   
Anxiety  1 [1]  3/30 (10.00%)  3
Renal and urinary disorders   
Renal failure, acute  1 [1]  1/30 (3.33%)  1
Respiratory, thoracic and mediastinal disorders   
Acute respiratory distress syndrome  1 [1]  2/30 (6.67%)  2
Dyspnoea  1 [1]  1/30 (3.33%)  1
Hypoxia  1 [1]  2/30 (6.67%)  2
Oropharyngeal pain  1 [1]  2/30 (6.67%)  2
Pneumothorax  1 [1]  1/30 (3.33%)  1
Respiratory acidosis  1 [1]  1/30 (3.33%)  1
Skin and subcutaneous tissue disorders   
Blister  1 [2]  1/30 (3.33%)  1
Pruritis  1 [3]  5/30 (16.67%)  5
Rash vesicular  1 [4]  1/30 (3.33%)  1
Red man syndrome  1 [1]  1/30 (3.33%)  1
Surgical and medical procedures   
Debridement  1 [1]  1/30 (3.33%)  1
Wisdom teeth removal  1 [1]  1/30 (3.33%)  1
Wound drainage  1 [1]  1/30 (3.33%)  1
Vascular disorders   
Hypertension  1 [1]  3/30 (10.00%)  3
Hypotension  1 [1]  2/30 (6.67%)  3
Thrombophlebitis  1 [1]  1/30 (3.33%)  1
1
Term from vocabulary, MedDRA
Indicates events were collected by systematic assessment
[1]
All adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue.
[2]
Adverse events (AE) were judged to be possibly related to treatment with StrataGraft skin tissue.
[3]
Three subjects adverse events (AE) were judged to be unrelated to treatment with StrataGraft skin tissue. Two subjects AE were judged to be possibly related to treatment with StrataGraft skin tissue.
[4]
Adverse events (AE) were judged to be probably related to treatment with StrataGraft skin tissue.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mary Lokuta
Organization: Stratatech Corporation, a Mallinckrodt Company
Phone: 608-441-8358
EMail: mlokuta@stratatechcorp.com
Layout table for additonal information
Responsible Party: Mallinckrodt ( Stratatech, a Mallinckrodt Company )
ClinicalTrials.gov Identifier: NCT01437852     History of Changes
Other Study ID Numbers: STRATA2011
WFUHS 40269 ( Other Grant/Funding Number: AFIRM )
First Submitted: September 19, 2011
First Posted: September 21, 2011
Results First Submitted: October 3, 2017
Results First Posted: December 13, 2018
Last Update Posted: October 16, 2019