Wound of SkinNCT05330767
DermaClose DUKE Fasciotomy and Wound Study
An observational study of Wound of Skin, run by Baxter Healthcare Corporation at 1 site in United States.
Trial summary
To evaluate the clinical performance of DermaClose and DermaClose XL Continuous External Tissue Expander (CETE) devices to reduce wound size and/or assist with closure in acute full thickness wounds of the skin and assess the need for skin grafting for patients undergoing a four-compartment leg fasciotomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound of Skin
- What is being tested?
- DermaClose Continuous External Tissue Expander Device, DermaClose XL Continuous External Tissue Expander Device and Conventional wound dressings
- Type of treatment
- Medical device
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2022to 13 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include patients who have acute full thickness wound(s) of the skin (including four-compartment leg fasciotomy) and in whom DermaClose and/or DermaClose XL, or conventional dressing is used.
Who may be able to join
- Patient is at least 18 years of age at the time of consent.
- Patient with a full thickness acute wound(s) of the skin:
- On either the upper or lower extremity (including four-compartment leg fasciotomy), in whom DermaClose and/or DermaClose XL is applied during surgery, OR
- Undergoing a four-compartment leg fasciotomy requiring conventional wound dressing.
- Patient has signed a written informed consent form (ICF) per 21 Code of Federal Regulations (CFR) Part 50.55(e).
Who cannot join
- Patient in whom the product was used off-label (except for patients who have the device on for longer than 14 days)
- Patient with wound(s) that exhibit any of the following:
- Ischemic tissue,
- Infected tissue,
- Acute burned tissue,
- Fragile tissue at the edges of the wound(s).
- Patient, who in surgeon's opinion, does not fit the criteria for this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: DermaClose Continuous External Tissue Expander for the Management of Four-Compartment Fasciotomy and Full-Thickness Wounds.
To evaluate the clinical performance of DermaClose and DermaClose XL Continuous External Tissue Expander (CETE) devices to reduce wound size and/or assist with closure in acute full thickness wounds of the skin and assess the need for skin grafting for patients undergoing a four-compartment leg fasciotomy.
- Conditions
- Wound of Skin
- Being tested
- DermaClose Continuous External Tissue Expander Device, DermaClose XL Continuous External Tissue Expander Device, Conventional wound dressings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DermaClose Continuous External Tissue Expander DeviceDevice
Constant tension and self-tensioning device. Supplied sterile and for single use only.
DermaClose XL Continuous External Tissue Expander DeviceDevice
Intended for large wounds that are greater than 8 cm in width. Constant tension and self-tensioning device. Supplied sterile and for single use only
Conventional wound dressingsDevice
Wet-to-dry, gauze, and negative pressure wound therapy.
| Study group | Role | What they receive |
|---|---|---|
| Wound on either the upper or lower extremity with DermaClose and/or DermaClose XL | Non-fasciotomy Receives: Device: DermaClose Continuous External Tissue Expander Device; Device: DermaClose XL Continuous External Tissue Expander Device | |
| Wound undergoing fasciotomy with DermaClose and/or DermaClose XL | Not described Receives: Device: DermaClose Continuous External Tissue Expander Device; Device: DermaClose XL Continuous External Tissue Expander Device | |
| Wound undergoing fasciotomy with conventional wound dressings | Not described Receives: Device: Conventional wound dressings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of investigator-confirmed wound size reduction or assistance with closure of acute full thickness wounds
Wounds may result from four-compartment leg fasciotomies.
Measured: Up to 14 Days (or longer if deemed necessary by surgeon)
Secondary outcomes (5)
Mean percentage of wound size reduction
Calculated at time of device removal.
Measured: Up to 14 Days (or longer if deemed necessary by surgeon)
Median number of days until wound closure
Defined as the ability to complete surgical closure.
Measured: Up to 14 Days (or longer if deemed necessary by surgeon)
Proportion of wounds treated with subsequent reconstruction with a skin graft after fasciotomy
Plastic surgery may be consulted for reconstruction by the referring surgeon, or the patient may be recommended for study inclusion by the referring surgeon who plans on using conventional dressing to manage the wound(s).
Measured: Up to 60 Days
Proportion of wounds requiring subsequent surgical procedure(s) for wound closure
Includes participants with conventional closure modality or skin graft
Measured: Up to 60 Days
Number of days until hospital discharge
Median time (min, max) in days will be calculated.
Measured: Up tp 60 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start22 Aug 2022
- Primary completion13 Nov 2023
- Study completion13 Nov 2023
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound of SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Duke University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05330767
- Sponsor's protocol ID
- BXU568622
- Status last verified
- Mar 2025
- First submitted
- 8 Apr 2022
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Sharing of Clinical Trial Data: Baxter is committed to sharing clinical trial data with external medical experts and scientific researchers in the interest of advancing public health. As such, Baxter will supply anonymized Individual Patient Datasets (IPD) and supporting documents (synopsis of clinical study reports, protocol and SAP's)
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DermaClose Continuous External Tissue Expander for the Management of Four-Compartment Fasciotomy and Full-Thickness Wounds.
- ClinicalTrials.gov ID
- NCT05330767
- Acronym / sponsor ID
- BXU568622
- Conditions
- Wound of Skin
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Duke University
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- 13 Nov 2023 (actual)
- Study completion
- 13 Nov 2023 (actual)
- First posted
- 15 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the clinical performance of DermaClose and DermaClose XL Continuous External Tissue Expander (CETE) devices to reduce wound size and/or assist with closure in acute full thickness wounds of the skin and assess the need for skin grafting for patients undergoing a four-compartment leg fasciotomy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Wound on either the upper or lower extremity with DermaClose and/or DermaClose XL | – | Device: DermaClose Continuous External Tissue Expander Device, Device: DermaClose XL Continuous External Tissue Expander DeviceNon-fasciotomy |
| Wound undergoing fasciotomy with DermaClose and/or DermaClose XL | – | Device: DermaClose Continuous External Tissue Expander Device, Device: DermaClose XL Continuous External Tissue Expander Device |
| Wound undergoing fasciotomy with conventional wound dressings | – | Device: Conventional wound dressings |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include patients who have acute full thickness wound(s) of the skin (including four-compartment leg fasciotomy) and in whom DermaClose and/or DermaClose XL, or conventional dressing is used.
Key inclusion criteria (5 listed)
- Patient is at least 18 years of age at the time of consent.
- Patient with a full thickness acute wound(s) of the skin:
- Patient has signed a written informed consent form (ICF) per 21 Code of Federal Regulations (CFR) Part 50.55(e).
Key exclusion criteria (7 listed)
- Patient in whom the product was used off-label (except for patients who have the device on for longer than 14 days)
- Patient with wound(s) that exhibit any of the following:
- Patient, who in surgeon's opinion, does not fit the criteria for this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DermaClose Continuous External Tissue Expander DeviceConstant tension and self-tensioning device. Supplied sterile and for single use only. | Device | Wound on either the upper or lower extremity with DermaClose and/or DermaClose XL, Wound undergoing fasciotomy with DermaClose and/or DermaClose XL |
| DermaClose XL Continuous External Tissue Expander DeviceIntended for large wounds that are greater than 8 cm in width. Constant tension and self-tensioning device. Supplied sterile and for single use only | Device | Wound on either the upper or lower extremity with DermaClose and/or DermaClose XL, Wound undergoing fasciotomy with DermaClose and/or DermaClose XL |
| Conventional wound dressingsWet-to-dry, gauze, and negative pressure wound therapy. | Device | Wound undergoing fasciotomy with conventional wound dressings |
Primary outcome
Proportion of investigator-confirmed wound size reduction or assistance with closure of acute full thickness wounds
Time frame: Up to 14 Days (or longer if deemed necessary by surgeon)
Wounds may result from four-compartment leg fasciotomies.
5 secondary outcomes
Mean percentage of wound size reduction
Time frame: Up to 14 Days (or longer if deemed necessary by surgeon)
Median number of days until wound closure
Time frame: Up to 14 Days (or longer if deemed necessary by surgeon)
Proportion of wounds treated with subsequent reconstruction with a skin graft after fasciotomy
Time frame: Up to 60 Days
Proportion of wounds requiring subsequent surgical procedure(s) for wound closure
Time frame: Up to 60 Days
Number of days until hospital discharge
Time frame: Up tp 60 Days
Results and safety
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Individual participant dataSharing planned: Yes. Sharing of Clinical Trial Data: Baxter is committed to sharing clinical trial data with external medical experts and scientific researchers in the interest of advancing public health. As such, Baxter will supply anonymized Individual Patient Datasets (IPD) and supporting documents (synopsis of clinical study reports, protocol and SAP's)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wound of Skin, run by Baxter Healthcare Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of investigator-confirmed wound size reduction or assistance with closure of acute full thickness wounds (time frame: Up to 14 Days (or longer if deemed necessary by surgeon)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.