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SASS 2 : Self Assembled Skin Substitute for the Autologous Treatment of Severe Burn Wounds in Acute Stage of Burn Trauma

Primary Purpose

Burns

Status

Recruiting

Phase

Phase 1

Locations

Canada

Study Type

Interventional

Intervention

Self assembled skin substitute (SASS)

About this trial

This is an interventional treatment trial for Burns focused on measuring Burn wounds, Burns, Skin substitute

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Deep second degree burns or third degree burns over 50% TBSA (Total body surface area) at time of recruitment or as determined by the surgeon;
Limited availability of donor sites for autografts;
Consent obtained by the participant or by the appropriate representative in case of inapt prospective participants or minors.

Exclusion Criteria:

Skin grafting needed only on the face, hands, feet, ears or genital area;
Connective tissue diseases;
Hypersensitivity to bovine proteins;
Coagulation disorders prior being burned;
Immunodeficiency prior being burned;
Uncontrolled diabetes prior being burned;
Permanent wound coverage before SASS grafts are ready;

Sites / Locations

Foothill Medcial CentreRecruiting
Mackenzie Health Science's CentreRecruiting
BC Children's Hospital Plastic Surgery ClinicRecruiting
Winnipeg Health Science CenterRecruiting
Hospital for Sick Children (Sickkids)Recruiting
Hôpital Sainte JustineRecruiting
CHU de Québec - Unité des grands brûlésRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (SASS)

Arm Description

Phase A: All patients will receive both Self assembled skin substitute (SASS) and Split-thickness autograft (paired samples sites A+ B). // Phase B: All patients will receive Self assembled skin subsitute (SASS)

Outcomes

Primary Outcome Measures

Percentage of graft take site A vs site B (Phase A 17 patients)

Clinical assessment; Image analysis

Percentage of graft take of all SASS (Phase A+B)

Clinical assessment

Percentage of graft take according to sites (Phase A+B)

Clinical assessment

Secondary Outcome Measures

Scar evaluation site A vs site B (Phase A 17 patients)

Vancouver Scar Scales; Cutometer; Mexameter; Dermascan; Images;

Scar evaluation according to sites (Phase A+B)

Cutometer; Mexameter; Dermascan; Images;

Incidence of adverse events site A vs site B (Phase A 17 patients)

Clinical assessment: Infection, Hematoma below the graft, corrective surgery, inclusion of cysts, granulation buds, other

Incidence of adverse events of all SASS (Phase A+B)

Clinical assessment: Infection, Hematoma below the graft, corrective surgery, inclusion of cysts, granulation buds, other

Quality of life survey (Phase A+B)

Survey BSHS-B ( brief version of the Burn Specific Health Scale)

Ratio harvested surface vs covered surface (Phase A+B)

Planimetric analysis; Clinical assessment; Images; Image analysis;

Full Information

NCT ID

NCT02350205

First Posted

January 15, 2015

Last Updated

September 14, 2023

Sponsor

CHU de Quebec-Universite Laval

1. Study Identification

Unique Protocol Identification Number

NCT02350205

Brief Title

SASS 2 : Self Assembled Skin Substitute for the Autologous Treatment of Severe Burn Wounds in Acute Stage of Burn Trauma

Official Title

SASS 2 : Self Assembled Skin Substitute for the Autologous Treatment of Severe Burn Wounds in Acute Stage of Burn Trauma.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 2015 (Actual)

Primary Completion Date

January 2028 (Anticipated)

Study Completion Date

January 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

CHU de Quebec-Universite Laval

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This clinical trial is designed to assess the safety, effectiveness and benefits of Self Assembled Skin Substitute SASS grafts as a permanent skin replacement for the treatment of full-thickness burn wounds that require permanent coverage where the availability of donor sites is limited.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Burns

Keywords

Burn wounds, Burns, Skin substitute

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment (SASS)

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Self assembled skin substitute (SASS)

Intervention Description

All patients in Phase B will receive Self assembled skin substitute (SASS)

Primary Outcome Measure Information:

Title

Percentage of graft take site A vs site B (Phase A 17 patients)

Description

Clinical assessment; Image analysis

Time Frame

< 1 month

Title

Percentage of graft take of all SASS (Phase A+B)

Description

Clinical assessment

Time Frame

< 1 month

Title

Percentage of graft take according to sites (Phase A+B)

Description

Clinical assessment

Time Frame

< 1 month

Secondary Outcome Measure Information:

Title

Scar evaluation site A vs site B (Phase A 17 patients)

Description

Vancouver Scar Scales; Cutometer; Mexameter; Dermascan; Images;

Time Frame

3, 6, 12, 24 and 36 months

Title

Scar evaluation according to sites (Phase A+B)

Description

Cutometer; Mexameter; Dermascan; Images;

Time Frame

3, 6, 12, 24 and 36 months

Title

Incidence of adverse events site A vs site B (Phase A 17 patients)

Description

Clinical assessment: Infection, Hematoma below the graft, corrective surgery, inclusion of cysts, granulation buds, other

Time Frame

24 to 36 months

Title

Incidence of adverse events of all SASS (Phase A+B)

Description

Clinical assessment: Infection, Hematoma below the graft, corrective surgery, inclusion of cysts, granulation buds, other

Time Frame

24 to 36 months

Title

Quality of life survey (Phase A+B)

Description

Survey BSHS-B ( brief version of the Burn Specific Health Scale)

Time Frame

3, 6, 12, 24 and 36 months

Title

Ratio harvested surface vs covered surface (Phase A+B)

Description

Planimetric analysis; Clinical assessment; Images; Image analysis;

Time Frame

1 month

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Deep second degree burns or third degree burns over 50% TBSA (Total body surface area) at time of recruitment or as determined by the surgeon; Limited availability of donor sites for autografts; Consent obtained by the participant or by the appropriate representative in case of inapt prospective participants or minors. Exclusion Criteria: Skin grafting needed only on the face, hands, feet, ears or genital area; Connective tissue diseases; Hypersensitivity to bovine proteins; Coagulation disorders prior being burned; Immunodeficiency prior being burned; Uncontrolled diabetes prior being burned; Permanent wound coverage before SASS grafts are ready;

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Veronique J Moulin, PhD

Phone

418-525-4444

Ext

61715

veronique.moulin@fmed.ulaval.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Lucie Germain, PhD

Phone

418-525-4444

Ext

61696

lucie.germain@fmed.ulaval.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Veronique J Moulin, PhD

Organizational Affiliation

CHU de Quebec

Official's Role

Principal Investigator

Facility Information:

Facility Name

Foothill Medcial Centre

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 2T9

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Vincent Gabriel, MD

Facility Name

Mackenzie Health Science's Centre

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2B7

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Edward Tredget, MD

Facility Name

BC Children's Hospital Plastic Surgery Clinic

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6H 3V4

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sally Hynes, MD

Facility Name

Winnipeg Health Science Center

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3A 1R9

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sarvesh Logsetty, MD

Facility Name

Hospital for Sick Children (Sickkids)

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 1X8

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joel Fish, MD

Facility Name

Hôpital Sainte Justine

City

Montréal

State/Province

Quebec

ZIP/Postal Code

H3T 1C5

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Patricia Bortoluzzi, MD

Facility Name

CHU de Québec - Unité des grands brûlés

City

Québec

ZIP/Postal Code

G1J 1Z4

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chanel Beaudoin-Cloutier, MD

12. IPD Sharing Statement

Learn more about this trial

SASS 2 : Self Assembled Skin Substitute for the Autologous Treatment of Severe Burn Wounds in Acute Stage of Burn Trauma

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