Wound ClosureSAGGANCT07695688
Safety Study of Microlyte DualGuard
A study testing Microlyte DualGuard in people with Wound Closure and Wound Care, run by Imbed Biosciences at 3 sites in United States.
Trial summary
The primary purpose of this research is to evaluate the safety and effectiveness of Microlyte® DualGuard wound dressing in the healing of partial thickness donor site wounds, also known as skin graft donor sites. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Wound Closure, Wound Care
- What is being tested?
- Microlyte DualGuard
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Aug 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients where creation of a donor site wound for any indication including chronic wound, burn wound, surgical/traumatic wound, and tumor excision is indicated.
- Thigh donor site wound (DSW) location.
- At least 22 years of age.
- Ability to understand and provide a signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for all visits for the duration of the study.
- All female subjects of childbearing potential (not surgically sterile or postmenopausal) and male subjects with female partners of childbearing potential must agree to use effective contraception (such as implants, injectables, combined oral contraceptives, intrauterine device, sexual abstinence, vasectomy or vasectomized partner) for the duration of the study (84 days).
- Fitzpatrick Skin Type (FST I-VI) assessment and documentation at baseline. Subjects of all FST categories (I-VI) are eligible, and the enrollment strategy will ensure that the full range of FST is represented in the study population (10% minimum enrollment in each FST sub-category).
Who cannot join
- DSW size of > 310 cm2
- Calculated glomerular filtration rate (GFR) <60 ml/min
- Hypocalcemia defined as serum corrected calcium of <8.0 mg/dl
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 times the upper limit of normal (ULN).
- Serum Creatinine > 2.0 mg/dL.
- Pregnant, lactating or nursing women.
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- Unable to provide consent.
- Prior adverse reaction or known sensitivity to silver or gallium.
- Enrollment in another interventional trial using a systemic therapeutic within 30 days prior to enrollment for this study.
- Presumed impairment of wound healing as with prescription drugs or medical diagnoses that have potential to impair wound healing at the discretion of clinical investigator, e.g., cancer, transplant status, autoimmune disease, severe malnutrition, etc.
- Any diagnosis with concern for 30-Day mortality.
- Any condition that might impair the evaluation of subject safety or that in the investigator opinion would interfere with study requirements.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
University Medical Center New Orleans, LSU Health NOLA
New Orleans, Louisiana, 70112
Shana Lennard, RN, BSN, CCRP, 504-702-5171, slenna@lsuhsc.edu
Jeffrey E Carter, MD, FACS, FABA
Valleywise Health Medical Center
Phoenix, Arizona, 85008
Lora Nordstrom, PHD, BSN, CCRC, CHRC, 602-344-2759, lora.nordstrom@valleywisehealth.org
Kevin Foster, MD, MBA, FACS
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Melissa McLawhorn, RN, BSN, 202-877-6181, melissa.m.mclawhorn@medstar.net
Jeffrey W Shupp, MD
About this study
Official title: Feasibility Clinical Trial to Assess the Safety and Potential Effectiveness of Microlyte® DualGuard Wound Dressing on Surgically Created Partial-thickness Donor Site Wounds on Patients Requiring Split- Thickness Skin Grafting; the SAGGA Trial
The primary purpose of this research is to evaluate the safety and effectiveness of Microlyte® DualGuard wound dressing in the healing of partial thickness donor site wounds, also known as skin graft donor sites. This research will assess wound healing, the occurrence of infection, allergic reaction, pain, and itching while subjects are in the hospital and after discharge. Subjects will complete clinic visits through 12 weeks. This research will also assess the occurrence of donor site wound infection, pain and itching, and scarring at 12 weeks, assessed by subjects using the Patient and Observer Scar Assessment Scale (POSAS).
Read the detailed description
This study is a multi-center randomized, controlled, open-label, split-wound clinical trial to assess the safety and potential effectiveness in wound healing of the Microlyte® DualGuard wound dressing in surgically created partial-thickness donor site wounds (DSW) on patients requiring split-thickness skin grafting.
This clinical trial is designed to demonstrate safety and effectiveness of the Microlyte® DualGuard wound dressing. We note that this clinical trial is designed for the management of surgically created clean acute donor-site wounds. These surgically clean acute wounds have high tendency to heal with the standard of care if supervised diligently, especially under the monitoring of a clinical trial.
Donor site wounds are created regularly in surgical hospitals as a means to utilize split-thickness skin grafts for closure of chronic, traumatic, infectious, oncologic, burn and other wounds. A donor site wound is a reproducible partial thickness wound. At the same time, it is associated with morbidity including pain, long healing times, risk of infection, and long-term cosmetic changes. Thus, it is the ideal model for assessment of safety and effectiveness of topical products engineered for wound healing and infection control. The donor site can easily be divided into two halves that are amenable to randomization using intra-patient controls to maximize the chances of assessing safety and effectiveness.
- Conditions
- Wound Closure, Wound Care
- Being tested
- Microlyte DualGuard, Allevyn Foam (Standard of Care Control)
- Keywords
- Donor site wound, antimicrobial, wound dressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microlyte DualGuardDevice
Microlyte® DualGuard wound dressing: It is a sterile, single use synthetic polyvinyl alcohol absorbent sheet with ionic gallium, and with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver and gallium with maximum of 0.16 mg/sq. in. and 1 mg/sq. in., respectively. Microlyte® DualGuard wound dressing absorbs wound fluid and forms a soft gel that conforms to the wound surface and maintains a moist environment. The dressing contains silver and gallium only to prevent or minimize microbial growth within the dressing.
Allevyn Foam (Standard of Care Control)Device
Allevyn® is indicated for as wound management by secondary intention on shallow, granulating wounds, chronic and acute exuding wounds, full- and partial-thickness wounds including: leg ulcers, diabetic foot ulcers, surgical wounds, first- and second-degree burns, skin graft donor site, skin tears, and pressure injuries.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm - Proximal or Distal DSW location | Experimental | Treatment with Microlyte DualGuard (investigational device) Receives: Device: Microlyte DualGuard |
| Standard of Care Arm - opposite side of DSW from treatment arm | Active comparator | The DSW will have a side (proximal or distal) that is randomized to Microlyte DualGuard. The opposite side (proximal or distal) will be treated with standard of care foam dressing (Allevyn). Receives: Device: Allevyn Foam (Standard of Care Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of wound closure defined as skin re-epithelialization without drainage or dressing requirements, confirmed at two consecutive study visits 2 weeks apart (Day 14 and Day 28)
Measured: From enrollment to Day 84
Adverse event occurrence, including infection
Measured: From enrollment to Day 84
Secondary outcomes (7)
Debridement - yes or no
Measured: Enrollment to Day 84
Pain as measured using a 10-point VAS
Measured: Enrollment to Day 84
Itching as assessed using a 10-point VAS
Measured: Enrollment to Day 84
Time, in days, to complete DSW closure
Measured: Enrollment to Day 84
Percentage of donor site wound closure at Day 9
Measured: Enrollment to Day 9
Quality of healing, evaluated using the Patient Observer Scare Assessment Scale (POSAS)
Measured: Day 84
Durability of wound closure at 12 weeks
Measured: Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start30 Aug 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound ClosureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-center, open label, randomized, split-wound controlled trial
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imbed Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Kevin Foster, MD, MBA, FACS, Principal investigator, Valleywise Health Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07695688
- Sponsor's protocol ID
- ID MIDRP 01
- Other IDs
- W81XWH-15-9-0001
- Acronym
- SAGGA
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Clinical Trial to Assess the Safety and Potential Effectiveness of Microlyte® DualGuard Wound Dressing on Surgically Created Partial-thickness Donor Site Wounds on Patients Requiring Split- Thickness Skin Grafting; the SAGGA Trial
- ClinicalTrials.gov ID
- NCT07695688
- Acronym / sponsor ID
- SAGGA / ID MIDRP 01
- Conditions
- Wound Closure, Wound Care
- Keywords
- Donor site wound, antimicrobial, wound dressing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Imbed BiosciencesIndustry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 10 Jul 2026 (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.
The primary purpose of this research is to evaluate the safety and effectiveness of Microlyte® DualGuard wound dressing in the healing of partial thickness donor site wounds, also known as skin graft donor sites. This research will assess wound healing, the occurrence of infection, allergic reaction, pain, and itching while subjects are in the hospital and after discharge. Subjects will complete clinic visits through 12 weeks. This research will also assess the occurrence of donor site wound infection, pain and itching, and scarring at 12 weeks, assessed by subjects using the Patient and Observer Scar Assessment Scale (POSAS).
Detailed description
This study is a multi-center randomized, controlled, open-label, split-wound clinical trial to assess the safety and potential effectiveness in wound healing of the Microlyte® DualGuard wound dressing in surgically created partial-thickness donor site wounds (DSW) on patients requiring split-thickness skin grafting.
This clinical trial is designed to demonstrate safety and effectiveness of the Microlyte® DualGuard wound dressing. We note that this clinical trial is designed for the management of surgically created clean acute donor-site wounds. These surgically clean acute wounds have high tendency to heal with the standard of care if supervised diligently, especially under the monitoring of a clinical trial.
Donor site wounds are created regularly in surgical hospitals as a means to utilize split-thickness skin grafts for closure of chronic, traumatic, infectious, oncologic, burn and other wounds. A donor site wound is a reproducible partial thickness wound. At the same time, it is associated with morbidity including pain, long healing times, risk of infection, and long-term cosmetic changes. Thus, it is the ideal model for assessment of safety and effectiveness of topical products engineered for wound healing and infection control. The donor site can easily be divided into two halves that are amenable to randomization using intra-patient controls to maximize the chances of assessing safety and effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multi-center, open label, randomized, split-wound controlled trial
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm - Proximal or Distal DSW location | Experimental | Device: Microlyte DualGuardTreatment with Microlyte DualGuard (investigational device) |
| Standard of Care Arm - opposite side of DSW from treatment arm | Active comparator | Device: Allevyn Foam (Standard of Care Control)The DSW will have a side (proximal or distal) that is randomized to Microlyte DualGuard. The opposite side (proximal or distal) will be treated with standard of care foam dressing (Allevyn). |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult patients where creation of a donor site wound for any indication including chronic wound, burn wound, surgical/traumatic wound, and tumor excision is indicated.
- Thigh donor site wound (DSW) location.
- At least 22 years of age.
- Ability to understand and provide a signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for all visits for the duration of the study.
Key exclusion criteria (12 listed)
- DSW size of > 310 cm2
- Calculated glomerular filtration rate (GFR) <60 ml/min
- Hypocalcemia defined as serum corrected calcium of <8.0 mg/dl
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 times the upper limit of normal (ULN).
- Serum Creatinine > 2.0 mg/dL.
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 |
|---|---|---|
| Microlyte DualGuardMicrolyte® DualGuard wound dressing: It is a sterile, single use synthetic polyvinyl alcohol absorbent sheet with ionic gallium, and with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver and gallium with maximum of 0.16 mg/sq. in. and 1 mg/sq. in., respectively. Microlyte® DualGuard wound dressing absorbs wound fluid and forms a soft gel that conforms to the wound surface and maintains a moist environment. The dressing contains silver and gallium only to prevent or minimize microbial growth within the dressing. | Device | Treatment Arm - Proximal or Distal DSW location |
| Allevyn Foam (Standard of Care Control)Allevyn® is indicated for as wound management by secondary intention on shallow, granulating wounds, chronic and acute exuding wounds, full- and partial-thickness wounds including: leg ulcers, diabetic foot ulcers, surgical wounds, first- and second-degree burns, skin graft donor site, skin tears, and pressure injuries. | Device | Standard of Care Arm - opposite side of DSW from treatment arm |
Primary outcome
Incidence of wound closure defined as skin re-epithelialization without drainage or dressing requirements, confirmed at two consecutive study visits 2 weeks apart (Day 14 and Day 28)
Time frame: From enrollment to Day 84
Adverse event occurrence, including infection
Time frame: From enrollment to Day 84
7 secondary outcomes
Debridement - yes or no
Time frame: Enrollment to Day 84
Pain as measured using a 10-point VAS
Time frame: Enrollment to Day 84
Itching as assessed using a 10-point VAS
Time frame: Enrollment to Day 84
Time, in days, to complete DSW closure
Time frame: Enrollment to Day 84
Percentage of donor site wound closure at Day 9
Time frame: Enrollment to Day 9
Quality of healing, evaluated using the Patient Observer Scare Assessment Scale (POSAS)
Time frame: Day 84
Durability of wound closure at 12 weeks
Time frame: Day 84
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Kevin Foster, MD, MBA, FACS principal investigator
Valleywise Health Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microlyte DualGuard in people with Wound Closure and Wound Care, run by Imbed Biosciences at 3 sites 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 7 inclusion and 12 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: opening soon, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brad Wiggins, BSN, RN, CBRN (888-472-9898, bwiggins@imbedbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of wound closure defined as skin re-epithelialization without drainage or dressing requirements, confirmed at two consecutive study visits 2 weeks apart (Day 14 and Day 28) (time frame: From enrollment to Day 84). The study lists 2 primary outcomes in all. 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 10 Jul 2026.