Trial Outcomes & Findings for Single-Stage Integra Reconstruction in Burns (NCT NCT03077087)

NCT ID: NCT03077087

Last Updated: 2023-03-14

Results Overview

95% healing determined as charted in Standard of Care follow up visits

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 2 participants
• Primary outcome timeframe: Up to 12 months
• Results posted on: 2023-03-14

Participant Flow

Participant milestones

Measure	Single-stage Integra Composed of a porous collagen-chondroitin 6-sulfate fibrillary mat covered with a thin sheet of silastic, it serves to cover wound beds of freshly excised burns and allow for the infiltration of fibroblasts, capillaries, and macrophages, essentially creating a "neodermis" while also acting as a barrier against infection and a blockade against heat and moisture loss thin Integra® (125 cm2): 125 cm2 represents approximately 0.7% of an average sized patient's total body surface area. The remaining injury areas would be covered with standard-thickness Integra® only. The donor graft, a 4 cm x 10 cm sheet of skin, would be meshed in a 3:1 ratio to be expanded to cover the 125 cm2 sheet of thin Integra®. The patient's post-operative care would be largely unchanged, although the patient would have a donor site of 40 cm2 that would be dressed and managed in the usual fashion.
Overall Study STARTED	2
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure

Single-stage Integra Composed of a porous collagen-chondroitin 6-sulfate fibrillary mat covered with a thin sheet of silastic, it serves to cover wound beds of freshly excised burns and allow for the infiltration of fibroblasts, capillaries, and macrophages, essentially creating a "neodermis" while also acting as a barrier against infection and a blockade against heat and moisture loss thin Integra® (125 cm2): 125 cm2 represents approximately 0.7% of an average sized patient's total body surface area. The remaining injury areas would be covered with standard-thickness Integra® only. The donor graft, a 4 cm x 10 cm sheet of skin, would be meshed in a 3:1 ratio to be expanded to cover the 125 cm2 sheet of thin Integra®. The patient's post-operative care would be largely unchanged, although the patient would have a donor site of 40 cm2 that would be dressed and managed in the usual fashion.

Overall Study Physician Decision

2

Baseline Characteristics

Single-Stage Integra Reconstruction in Burns

Baseline characteristics by cohort

Measure	Single-stage Integra n=2 Participants Composed of a porous collagen-chondroitin 6-sulfate fibrillary mat covered with a thin sheet of silastic, it serves to cover wound beds of freshly excised burns and allow for the infiltration of fibroblasts, capillaries, and macrophages, essentially creating a "neodermis" while also acting as a barrier against infection and a blockade against heat and moisture loss thin Integra® (125 cm2): 125 cm2 represents approximately 0.7% of an average sized patient's total body surface area. The remaining injury areas would be covered with standard-thickness Integra® only. The donor graft, a 4 cm x 10 cm sheet of skin, would be meshed in a 3:1 ratio to be expanded to cover the 125 cm2 sheet of thin Integra®. The patient's post-operative care would be largely unchanged, although the patient would have a donor site of 40 cm2 that would be dressed and managed in the usual fashion.
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 12 months

Population: Only two patients were enrolled in this study, and they were withdrawn from the trial prior to initiation of the intervention due to patient characteristics. No data was collected on the two withdrawn patients since the study intervention (graft) was not applied to either subject.

95% healing determined as charted in Standard of Care follow up visits

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 12 months

Population: No patient data was collected due to physician decision to withdraw the patient from the trial prior to initiation of the intervention. No data was collected on the two withdrawn patients since the study intervention (graft) was not applied to either subject.

Compared to the same characteristics of the adjacent (control) 125 cm2 skin graft

Outcome measures

Outcome data not reported

Adverse Events

Single-stage Integra

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure

Single-stage Integra n=2 participants at risk Composed of a porous collagen-chondroitin 6-sulfate fibrillary mat covered with a thin sheet of silastic, it serves to cover wound beds of freshly excised burns and allow for the infiltration of fibroblasts, capillaries, and macrophages, essentially creating a "neodermis" while also acting as a barrier against infection and a blockade against heat and moisture loss thin Integra® (125 cm2): 125 cm2 represents approximately 0.7% of an average sized patient's total body surface area. The remaining injury areas would be covered with standard-thickness Integra® only. The donor graft, a 4 cm x 10 cm sheet of skin, would be meshed in a 3:1 ratio to be expanded to cover the 125 cm2 sheet of thin Integra®. The patient's post-operative care would be largely unchanged, although the patient would have a donor site of 40 cm2 that would be dressed and managed in the usual fashion.

Vascular disorders Stroke

50.0% 1/2 • Number of events 1 • Adverse events were documented from the time of study enrollment (consenting) until the completion of study activities at 12 months (or until the patients were withdrawn from the study).

Other adverse events

Adverse event data not reported

Additional Information

Joshua S Rosenzweig / Study Coordinator

Regions Hospital

Phone: 651-254-3351

Email: joshua.s.rosenzweig@healthpartners.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place