Thermal Burn
Conditions
Brief summary
This is a prospective, descriptive, pilot case series involving patients with significant burns who are candidates for reconstruction with Integra®. Subjects would have a small area of the wound would, at the time of excision, have the smallest sheet of thin Integra® (125 cm2) placed and be immediately autografted with a 3:1 meshed split-thickness skin graft. Of note, 125 cm2 represents approximately 0.7% of an average sized patient's total body surface area, so for even the smallest burns in our proposed trial, this area would represent a small portion of the patient's area of injury. The remaining injury areas would be covered with standard-thickness Integra® only.
Detailed description
Integra®, a synthetic dermal substitute, has been utilized in burn care for decades. Typically, 10-14 days after Integra® placement, a patient returns to the operating room, the top silastic layer of the Integra® is removed, and an autograft - a split-thickness skin graft harvested from the patient - is applied directly on top of the incorporated Integra®. The result is regarded to be a cosmetically and functionally superior result to that which would have been obtained had the wound bed itself been autografted at the time of excision, as opposed to being covered by Integra® and autografted during a second operation. Integra® use in single-stage procedures to cover defects without grafting has shown benefit when defects are fairly small, e.g. fingertip injuries, and small head and neck skin cancer resections. While single-stage reconstruction with Integra® has been demonstrated with standard thickness Integra®, this decreased thickness would increase the likelihood of graft survival due to the decreased distance of nutrient diffusion.
Interventions
DEVICEthin 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.
Sponsors
HealthPartners Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 125 Years
Healthy volunteers
No
Inclusion criteria
* English-speaking adult burn patients greater than 18 years old, admitted with burn injuries eligible for Integra® reconstruction at the discretion of the burn attending physicians.
Exclusion criteria
* patients with isolated hand or face burns - these burns are treated with sheet grafts (unmeshed); the 3:1 mesh grafts would not be used on these cosmetically sensitive areas. If they have hand and/or face burns in addition to other areas, they will not be excluded. However, the study itself will not be performed on the hands or face. Additionally, patients unable to present to our clinic for routine follow-up due to geographic limitations or otherwise will be ineligible.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Time to 95% Healing of the Single-stage Reconstructed Skin Graft | Up to 12 months | 95% healing determined as charted in Standard of Care follow up visits |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Complications: Infection, Seroma, Hematoma, Sloughing, and Graft Loss | Up to 12 months | Compared to the same characteristics of the adjacent (control) 125 cm2 skin graft |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 2 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 2 |
Baseline characteristics
| Characteristic | Single-stage Integra |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2 |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 1 / 2 |
Outcome results
Primary
The Time to 95% Healing of the Single-stage Reconstructed Skin Graft
95% healing determined as charted in Standard of Care follow up visits
Time frame: 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.
Secondary
Frequency of Complications: Infection, Seroma, Hematoma, Sloughing, and Graft Loss
Compared to the same characteristics of the adjacent (control) 125 cm2 skin graft
Time frame: 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.