Compartment Syndrome, Wounds and Injuries
Conditions
Brief summary
Fasciotomy wounds are rarely able to be closed at the time of index surgery. They often require multiple returns to surgery for closure, and occasionally require skin grafting (i.e. they are never completely closed). We are interested in seeing whether this device, which provides constant and gradual tension on the wound, may allow for rapid wound closure in a safe fashion, perhaps even precluding a return trip to surgery. Null hypothesis #1: The Dermaclose Wound Management System (Woundcare Technologies Inc, Chanhassen, Minnesota) will not result in closure of fasciotomy wounds more rapidly than standard vessel loop techniques. Null hypothesis #2: The Dermaclose Wound Management System will not reduce the number of return trips to the operating room for surgical procedures related to closure or skin grafting of fasciotomy wounds.
Detailed description
After IRB approval, all patients meeting inclusion criteria and requiring fasciotomy of the arms, legs, or pelvis will be consented for participation in the research study. Patients will either have their fasciotomy wounds closed through application of the Dermaclose device, as per the manufacturer's instructions, or through application of vessel loops with staples in a shoestring technique as described in the literature (1). Choice of wound closure technique will be at surgeon discretion. All patients will undergo application of a vacuum-assisted wound closure device (Wound VAC, Active Healing Solutions Inc, San Antonio, TX), which is standard of care for temporary coverage of open wounds (2, 3). Patients will be returned to the operating room every 2-3 days until wound closure or skin grafting has been accomplished. If skin closure is not accomplished in the operating room, but occurs prior to return trip to the operating room, then definitive suture closure of the wound will be performed under local anaesthetic, followed by removal of the Dermaclose device or of the vessel loop with staple shoestring. Decisions regarding wound closure or skin grafting in the operating room will be left to the judgment of the attending surgeon.
Interventions
DEVICEDermaClose fasciotomy closure
The DermaClose device provides continuous expanding of the skin around the wound until it has stretched enough to allow the skin edges to be sutured closed.
DEVICEVessel loop
Vessel loops and staples for fasciotomy closure
Sponsors
Wound Care Technologies, Inc.
University of Missouri-Columbia
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients 18 years of age or older * Patients undergoing fasciotomy for decompression of compartment syndrome, evolving compartment syndrome, or prophylactically to prevent compartment syndrome
Exclusion criteria
* Patient younger than 18 years of age * Patients with an active infection * Patients unable to comply with protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance of DermaClose System in Treatment of Fasciotomy Wounds | One year | Days to wound closure; number and types of procedures required for wound closure; infection requiring reoperation; wound dehiscence requiring reoperation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain | One Year | Visual Analog Pain Scale (VAS) during initial hospitalization and at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months |
| Quality of Life | One Year | Quality of Life measured by the SF-12 version 1 at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months |
| Cost-to-Benefit Ratio of DermaClose Versus Vessel Loop Fasciotomy Closure | One year | Costs associated with both types of closure (DermaClose and Vessel Loop) including hospital days, number of procedures, procedural and hospital costs including device(s), negative pressure wound therapy costs, and operating room time and associated costs. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vessel Loop Fasciotomy Closure Fasciotomy closure using vessel loops and staples.
Vessel loop: Vessel loops and staples for fasciotomy closure | 0 |
| DermaClose Fasciotomy Closure Fasciotomy closure via DermaClose device
DermaClose Continuous External Tissue Expander: The DermaClose device provides continuous expanding of the skin around the wound until it has stretched enough to allow the skin edges to be sutured closed. | 7 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | screen failure | 0 | 1 |
Baseline characteristics
| Characteristic | DermaClose Fasciotomy Closure | Total |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 7 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 7 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 7 |
| serious Total, serious adverse events | 0 / 0 | 0 / 7 |
Outcome results
Primary
Performance of DermaClose System in Treatment of Fasciotomy Wounds
Days to wound closure; number and types of procedures required for wound closure; infection requiring reoperation; wound dehiscence requiring reoperation
Time frame: One year
Population: Too low of an enrollment volume to analyze
Secondary
Cost-to-Benefit Ratio of DermaClose Versus Vessel Loop Fasciotomy Closure
Costs associated with both types of closure (DermaClose and Vessel Loop) including hospital days, number of procedures, procedural and hospital costs including device(s), negative pressure wound therapy costs, and operating room time and associated costs.
Time frame: One year
Population: This study was terminated before this information was collected and analyzed.
Secondary
Pain
Visual Analog Pain Scale (VAS) during initial hospitalization and at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months
Time frame: One Year
Population: too low of an enrollment volume to analyze
Secondary
Quality of Life
Quality of Life measured by the SF-12 version 1 at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months
Time frame: One Year
Population: This study was terminated before any of this information was collected and analyzed.