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

• Sponsor: Stratatech, a Mallinckrodt Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01437852
• Collaborator: (none)
• Enrollment: 30
• Locations: 6
• Arm: 1
• Duration (Months): 37
• Patients Per Site: 5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The proposed study is designed as a phase Ib open-label, dose-escalation, multicenter study evaluating the safety, tolerability, and efficacy of StrataGraft skin tissue in promoting the healing of the deep partial-thickness component of complex skin defects. The proposed study population will include patients with 3-49% Total Body Surface Area (TBSA) complex skin defects including a deep partial-thickness component resulting from thermal injury. The study has been designed to focus on the evaluation of safety and tolerability of prolonged exposure to increasing amounts of a single application of StrataGraft skin tissue, while also assessing the potential for StrataGraft tissue to promote healing of the deep partial-thickness component of these complex skin defects as an alternative to donor site harvesting and autografting. Targeted enrollment for this study is up to 30 patients with complex skin defects due to thermal burns which require surgical excision and autografting. Subjects will be sequentially enrolled in two cohorts of increasing treatment area receiving StrataGraft skin tissue that has been stored refrigerated prior to clinical use. A third cohort will receive StrataGraft skin tissue which has been stored cryopreserved and thawed in the operating room just prior to grafting.

Condition or Disease	Intervention/Treatment	Phase
Skin Wound; Burns; Trauma-related Wound	Biological: StrataGraft Skin Tissue	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label, Controlled, Randomized, Multicenter, Dose Escalation Study Evaluating the Safety and Efficacy of StrataGraft® Skin Tissue in Promoting the Healing of the Deep Partial-Thickness Component of Complex Skin Defects as an Alternative to Autografting
• Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: Jan 1, 2014
• Actual Study Completion Date: Oct 1, 2014

Arms and Interventions

Arm

Intervention/Treatment

Experimental: StrataGraft skin tissue All subjects enrolled in this study will receive StrataGraft tissue. Will randomly assign treatment regimens to the two comparable study treatment sites pre-identified as A or B. A sealed randomization envelope will be supplied to the clinical site along with the shipment of clinical tissue. Neither the surgeon nor scrubbed operating room personnel will be informed of the randomization until completion of surgical excision. The treatment sites A or B will be randomized to receive either StrataGraft skin tissue or autograft using a 1:1 ratio. Two comparable areas of healthy skin will be pre-identified by the clinical staff as donor sites A or B. The randomization assignment will be identical as that above for the treatment sites. For example, if treatment site A is randomized to receive an autograft, donor site A will be designated the donor site for autografting

Biological: StrataGraft Skin Tissue

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Wound Closure of the Treatment Sites at Three Months [3 months]

   Determination of complete wound closure of both treatment sites was evaluated at 3 months.

2. Percent Area of the StrataGraft Treatment Site Requiring Autografting by Day 28 [28 days]

   The percentage of the treatment site area initially covered with StrataGraft tissue that required autograft by day 28 was determined.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Men and women aged 18-65 years, inclusive

• Written informed consent

• Sufficient healthy skin identified and designated as a donor site in the event that the StrataGraft treatment site requires autografting

• Complex skin defects of 3-49% TBSA requiring excision and autografting

• Total burn may consist of more than one wound area

• Deep partial-thickness thermal burn(s) with total area of 88 to 880 cm2 requiring excision and autografting

• First excision and grafting of treatment sites

Exclusion Criteria:

• Pregnant women and prisoners

• Patients receiving systemic immunosuppressive therapy

• Patients with a known history of malignancy

• Preadmission insulin-dependent diabetic patients

• Patients with concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives

• Expected survival of less than three months

• Participation in the treatment group of an interventional study within preceding 90 days prior to enrollment

• Full-thickness burns will be excluded as treatment sites

• Chronic wounds will be excluded as treatment sites

• The face, head, neck, hands, feet, buttocks, and areas over joints will be excluded as treatment sites

• Treatment sites adjacent to unexcised eschar

• Clinical suspicion of burn wound infection at the anticipated treatment sites

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maricopa Integrated Health Systems, Arizona Burn Center	Phoenix	Arizona	United States	85008
2	University of Colorado Hospital Burn Center	Aurora	Colorado	United States	80045
3	Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina	United States	27157
4	UT-Southwestern Medical Center	Dallas	Texas	United States	75390-9158
5	U.S. Army Institute of Surgical Research	Fort Sam Houston	Texas	United States	78234-6315
6	University of Wisconsin Hospital	Madison	Wisconsin	United States	53792

Sponsors and Collaborators

• Stratatech, a Mallinckrodt Company

Investigators

• Study Director: Study Director, Stratatech, Inc., a Mallinckrodt Pharmaceuticals Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stratatech, a Mallinckrodt Company
• ClinicalTrials.gov Identifier: NCT01437852
• Other Study ID Numbers: STRATA2011; WFUHS 40269
• First Posted: Sep 21, 2011
• Last Update Posted: Oct 16, 2019
• Last Verified: Dec 1, 2018

• Additional relevant MeSH terms: Wounds and Injuries

Study Results

Participant Flow

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 Detail	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
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

Baseline Characteristics

Arm/Group Title	StrataGraft Skin Tissue : Autograft
Arm/Group Description	Two comparable deep partial-thickness burns were excised and randomized to receive StrataGraft skin tissue or autograft.
Overall Participants	30
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	30 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41.0 (12.1)
Sex: Female, Male (Count of Participants)
Female	9 30%
Male	21 70%
Region of Enrollment (participants) [Number]
United States	30 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Wound Closure of the Treatment Sites at Three Months
Description	Determination of complete wound closure of both treatment sites was evaluated at 3 months.
Time Frame	3 months

Outcome Measure Data

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
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.
Measure Participants	29	29
Count of Participants [Participants]	29 96.7%	29 NaN

2. Primary Outcome

Title	Percent Area of the StrataGraft Treatment Site Requiring Autografting by Day 28
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

Outcome Measure Data

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
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.
Measure Participants	30
Median (Full Range) [Percentage of area]	0

Adverse Events

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
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 (%)	# Events
Total	0/30 (0%)
Serious Adverse Events
	StrataGraft Skin Tissue : Autograft
	Affected / at Risk (%)	# Events
Total	6/30 (20%)
General disorders
Impaired healing	1/30 (3.3%)	1
Infections and infestations
Cellulitis	1/30 (3.3%)	2
Pneumonia	1/30 (3.3%)	1
Nervous system disorders
Pain	1/30 (3.3%)	1
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism	1/30 (3.3%)	1
Skin and subcutaneous tissue disorders
Thermal burn	1/30 (3.3%)	1
Transplant failure	2/30 (6.7%)	3
Vascular disorders
Deep vein thrombosis	1/30 (3.3%)	1
Other (Not Including Serious) Adverse Events
	StrataGraft Skin Tissue : Autograft
	Affected / at Risk (%)	# Events
Total	27/30 (90%)
Blood and lymphatic system disorders
Anaemia	2/30 (6.7%)	2
Coagulopathy	1/30 (3.3%)	1
Cardiac disorders
Cardiac failure, congestive	1/30 (3.3%)	1
Tachycardia	1/30 (3.3%)	1
Eye disorders
Corneal neovascularization	1/30 (3.3%)	1
Eyelid oedema	1/30 (3.3%)	1
Gastrointestinal disorders
Constipation	1/30 (3.3%)	2
Dyspepsia	2/30 (6.7%)	2
Haemorrhoids	1/30 (3.3%)	1
Ileus	1/30 (3.3%)	1
Intestinal functional disorder	1/30 (3.3%)	1
Nausea	2/30 (6.7%)	2
General disorders
Chest pain	1/30 (3.3%)	1
Chills	1/30 (3.3%)	1
Impaired healing	2/30 (6.7%)	2
Pain	1/30 (3.3%)	1
Pyrexia	1/30 (3.3%)	1
Oedema	1/30 (3.3%)	1
Oedema peripheral	1/30 (3.3%)	1
Immune system disorders
Gout	1/30 (3.3%)	1
Sarcoidosis	1/30 (3.3%)	1
Infections and infestations
Abscess, limb	1/30 (3.3%)	1
Fungal infection	1/30 (3.3%)	1
Gastroenteritis	1/30 (3.3%)	1
Gastrointestinal infection	1/30 (3.3%)	1
Herpes simplex	1/30 (3.3%)	1
Influenza	1/30 (3.3%)	1
Keratitis, fungal	1/30 (3.3%)	1
Nasopharyngitis	1/30 (3.3%)	1
Post procedural infection	1/30 (3.3%)	1
Prostate infection	1/30 (3.3%)	1
Sepsis	1/30 (3.3%)	1
Sinusitis	1/30 (3.3%)	1
Urinary tract infection	1/30 (3.3%)	1
Wound infection, Staphylococcal	1/30 (3.3%)	1
Injury, poisoning and procedural complications
Cephalohematoma	1/30 (3.3%)	1
Excoriation	1/30 (3.3%)	1
Graft complication	2/30 (6.7%)	2
Graft infection	2/30 (6.7%)	2
Joint injury	1/30 (3.3%)	1
Laceration	2/30 (6.7%)	2
Procedural pain	1/30 (3.3%)	1
Wound haemorrhage	1/30 (3.3%)	1
Metabolism and nutrition disorders
Fluid overload	1/30 (3.3%)	1
Hypermetabolism	1/30 (3.3%)	1
Hypoalbuminaemia	1/30 (3.3%)	1
Musculoskeletal and connective tissue disorders
Arthralgia	3/30 (10%)	3
Joint contracture	2/30 (6.7%)	2
Joint swelling	1/30 (3.3%)	1
Muscule contracture	1/30 (3.3%)	2
Pain in extremity	2/30 (6.7%)	2
Nervous system disorders
Dizziness	1/30 (3.3%)	1
Headache	1/30 (3.3%)	1
Hyperaesthesia	1/30 (3.3%)	1
Hypoaesthesia	1/30 (3.3%)	1
Neuralgia	3/30 (10%)	3
Paraesthesia	1/30 (3.3%)	2
Peroneal nerve palsy	1/30 (3.3%)	1
Sensory disturbance	1/30 (3.3%)	1
Psychiatric disorders
Anxiety	3/30 (10%)	3
Renal and urinary disorders
Renal failure, acute	1/30 (3.3%)	1
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome	2/30 (6.7%)	2
Dyspnoea	1/30 (3.3%)	1
Hypoxia	2/30 (6.7%)	2
Oropharyngeal pain	2/30 (6.7%)	2
Pneumothorax	1/30 (3.3%)	1
Respiratory acidosis	1/30 (3.3%)	1
Skin and subcutaneous tissue disorders
Blister	1/30 (3.3%)	1
Pruritis	5/30 (16.7%)	5
Rash vesicular	1/30 (3.3%)	1
Red man syndrome	1/30 (3.3%)	1
Surgical and medical procedures
Debridement	1/30 (3.3%)	1
Wisdom teeth removal	1/30 (3.3%)	1
Wound drainage	1/30 (3.3%)	1
Vascular disorders
Hypertension	3/30 (10%)	3
Hypotension	2/30 (6.7%)	3
Thrombophlebitis	1/30 (3.3%)	1

Limitations/Caveats

[Not Specified]

More Information

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.