Safety Study of Microlyte DualGuard (SAGGA)
2026年7月6日 更新者：Imbed Biosciences
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).
調査の概要
状態
まだ募集していません
詳細な説明
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.
研究の種類
介入
入学 (推定)
53
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Brad Wiggins, BSN, RN, CBRN
- 電話番号：888-472-9898
- メール：bwiggins@imbedbio.com
研究連絡先のバックアップ
- 名前：Carrie M Huffman, MA, MPH, DLP, RAC-US
- 電話番号：301-337-8159
- メール：chuffman@imbedbio.com
研究場所
-
-
Arizona
-
Phoenix、Arizona、アメリカ、85008
- Valleywise Health Medical Center
-
コンタクト：
- Lora Nordstrom, PHD, BSN, CCRC, CHRC
- 電話番号：602-344-2759
- メール：lora.nordstrom@valleywisehealth.org
-
主任研究者：
- Kevin Foster, MD, MBA, FACS
-
-
District of Columbia
-
Washington D.C.、District of Columbia、アメリカ、20010
- MedStar Washington Hospital Center
-
コンタクト：
- Melissa McLawhorn, RN, BSN
- 電話番号：202-877-6181
- メール：melissa.m.mclawhorn@medstar.net
-
主任研究者：
- Jeffrey W Shupp, MD
-
-
Louisiana
-
New Orleans、Louisiana、アメリカ、70112
- University Medical Center New Orleans, LSU Health NOLA
-
コンタクト：
- Shana Lennard, RN, BSN, CCRP
- 電話番号：504-702-5171
- メール：slenna@lsuhsc.edu
-
主任研究者：
- Jeffrey E Carter, MD, FACS, FABA
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
- 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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Treatment Arm - Proximal or Distal DSW location
Treatment with Microlyte DualGuard (investigational device)
|
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.
|
|
アクティブコンパレータ：Standard of Care Arm - opposite side of DSW from treatment arm
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).
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
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)
時間枠：From enrollment to Day 84
|
From enrollment to Day 84
|
|
Adverse event occurrence, including infection
時間枠：From enrollment to Day 84
|
From enrollment to Day 84
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Debridement - yes or no
時間枠：Enrollment to Day 84
|
Enrollment to Day 84
|
|
Pain as measured using a 10-point VAS
時間枠：Enrollment to Day 84
|
Enrollment to Day 84
|
|
Itching as assessed using a 10-point VAS
時間枠：Enrollment to Day 84
|
Enrollment to Day 84
|
|
Time, in days, to complete DSW closure
時間枠：Enrollment to Day 84
|
Enrollment to Day 84
|
|
Percentage of donor site wound closure at Day 9
時間枠：Enrollment to Day 9
|
Enrollment to Day 9
|
|
Quality of healing, evaluated using the Patient Observer Scare Assessment Scale (POSAS)
時間枠：Day 84
|
Day 84
|
|
Durability of wound closure at 12 weeks
時間枠：Day 84
|
Day 84
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Kevin Foster, MD, MBA, FACS、Valleywise Health Medical Center
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年8月30日
一次修了 (推定)
2027年4月1日
研究の完了 (推定)
2027年8月1日
試験登録日
最初に提出
2026年7月6日
QC基準を満たした最初の提出物
2026年7月6日
最初の投稿 (実際)
2026年7月10日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月10日
QC基準を満たした最後の更新が送信されました
2026年7月6日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- ID MIDRP 01
- W81XWH-15-9-0001 (その他の識別子：Department of Defense)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
はい
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。