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Clinical Efficacy and Safety of Sericin Hydrogel Sheet Impregnated With Bird's Nest Extract

2021年9月20日 更新者：Pornanong Aramwit, Pharm.D., Ph.D、Chulalongkorn University

Clinical Efficacy and Safety of Sericin Hydrogel Sheet Impregnated With Bird's Nest Extract in Prevention of Hypertrophic Scar Development at Split-thickness Skin Graft Donor Site

Split-thickness skin graft (STSG) is one of the most common procedures performed in plastic surgery and dermatology. The donor site of skin grafting is expected to heal without scarring. However, hypertrophic scar formation is prevalent among STSG donor sites during scar maturation and has become a significant problem at present. Hypertrophic scar results in aesthetic, physical, functional, and psychological problems, leading to a dramatic impact on patients' quality of life ultimately. There are many current therapeutic approaches for preventing and treating hypertrophic scars; however, they remain clinically unsatisfactory because many treatments have been associated with high recurrent rates, high cost, and side effects. Currently, there are no gold standards for hypertrophic scar therapy. There are many attempts to develop new treatment options for the prevention and management of scarring that are acceptable to both physicians and patients. It has previously been shown that both edible bird's nest (EBN) extract and sericin have effectiveness in reducing scar development. They might be a suitable alternative option for scar prevention and could be used safely. Therefore, the sericin hydrogel sheet impregnated with EBN extract is developed as it is believed that the synergism of these combined compounds would be a great help to prevent the development of scars. This study aims to evaluate the efficacy and safety of sericin hydrogel sheet impregnated with EBN extract for the prevention of scar formation in patients with STSG donor sites.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

Prospective, randomized, single-center, double-blinded, placebo-controlled, matched pairs clinical study will be conducted to investigate the efficacy and safety of sericin hydrogel sheet impregnated with EBN extract for the prevention of scar development at STSG donor site. Patients who underwent the STSG procedure at the Division of Plastic and Reconstructive Surgery, Department of Surgery, King Chulalongkorn Memorial Hospital will be considered for inclusion and exclusion criteria. Thirty patients will be enrolled in this study. After complete epithelialization, each donor site will be equally divided into two halves: upper and lower halves. Both halves of the donor site will be randomized into sericin hydrogel sheet impregnated with EBN extract group (treatment group) or placebo hydrogel sheet group (control group). The application of both dressings will be done once daily by the patient in the morning or evening after shower. Both dressings will be recommended to wear over the donor site for 8-12 hours per day. The duration of treatment will be six months. Wound quality at 1, 2, 4, and 6 months after starting application will be measured in terms of erythema level, melanin level, transepidermal water loss by using Cutometer® and scar quality (Vancouver scar scale as well as Patient and Observer Scar Assessment Scale). Adverse reactions will also be evaluated.

研究の種類

介入

入学 (予想される)

30

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：Pornanong Aramwit, Ph.D
  • 電話番号：+66899217255
  • メール：aramwit@gmail.com

研究場所

  • タイ
      • Bangkok、タイ、10330
        • King Chulalongkorn Memorial Hospital
        • コンタクト：
        • 主任研究者：
          • Pornanong Aramwit, Ph.D

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

18年～65年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • STSG donor sites freshly closed not more than 1 month after completed epithelialization
  • STSG donor sites are at least 5 x 10 cm2 in size.
  • STSG donor sites are located on the thigh.
  • Donor sites have not been used previously for skin graft harvesting.
  • Aged 18-65 years
  • Patients who can read and write Thai language
  • Willingness to participate
  • Signed consent form

Exclusion Criteria:

  • Patients with critical illness (such as systemic infection), major acute illness, or chronic medical illness associated with delayed wound healing (such as poor-controlled diabetes mellitus, end-stage renal disease (ESRD), cancer, or immunocompromised diseases)
  • Patients with mental disorder
  • Patients with active dermatologic conditions such as contractive skin disorders (e.g., scleroderma), psoriasis, or atopic dermatitis
  • After completed epithelialization, patients who used other topical agents or dressings on STSG donor sites within 14 days prior to enrollment
  • Known sensitivity or allergy to sericin, EBN, other constituents in hydrogel sheet, or adhesive tape
  • Pregnancy

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：防止
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的：Sericin hydrogel sheet impregnated with EBN extract
Apply sericin hydrogel sheet impregnated with EBN extract on one-half of the donor site once daily for 8-12 hours per day for 6 months.
デバイス：Sericin hydrogel sheet impregnated with EBN extract
Sericin hydrogel sheet impregnated with EBN extract will be used as a primary dressing for preventing scar development at one-half of the STSG donor site. Then, the donor site will be covered with adhesive tape (secondary dressing). The application of primary and secondary dressings will be done once daily after shower in the morning or evening. Both dressings will be recommended to wear over the donor site for 8-12 hours per day. Patients will be advised to remove both dressings before shower to clean the donor site and the surrounding skin, and then replace them with new wound dressing sheets in the next day. The duration of the dressing application will be 6 months.
プラセボコンパレーター：Placebo hydrogel sheet
Apply placebo hydrogel sheet on another half of the donor site once daily for 8-12 hours per day for 6 months.
デバイス：Placebo hydrogel sheet
Placebo hydrogel sheet will be used as a primary dressing for preventing scar development at another half of the STSG donor site. Then, the donor site will be covered with adhesive tape (secondary dressing). The application of primary and secondary dressings will be done once daily after shower in the morning or evening. Both dressings will be recommended to wear over the donor site for 8-12 hours per day. Patients will be advised to remove both dressings before shower to clean the donor site and the surrounding skin, and then replace them with new wound dressing sheets in the next day. The duration of the dressing application will be 6 months.

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
メジャーの説明
時間枠
Vancouver Scar Scale (VSS) score
時間枠：6 months
Clinicians will evaluate scar quality using VSS at 6 months after commencing the dressing application. The range of score is 0 to 10. Higher scores mean a worse outcome.
6 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Patient and Observer Scar Assessment Scale (POSAS) score
時間枠：6 months
Clinicians will evaluate scar quality using POSAS at 1, 2, 4, and 6 months after commencing the dressing application. The range of score is 1 to 10. Normal skin will be recorded as scale 1. Higher scores mean a worse outcome.
6 months
Melanin level
時間枠：6 months
Melanin level will be measured using Cutometer® with mexameter mode at 1, 2, 4, and 6 months after commencing the dressing application.
6 months
Erythema level
時間枠：6 months
Erythema level will be measured using Cutometer® with mexameter mode at 1, 2, 4, and 6 months after commencing the dressing application.
6 months
Transepidermal water loss (TEWL)
時間枠：6 months
TEWL will be measured using Cutometer® with tewameter mode at 1, 2, 4, and 6 months after commencing the dressing application.
6 months
Adverse events
時間枠：6 months
Adverse events resulted from dressing application will be evaluated.
6 months

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

Chulalongkorn University

捜査官

  • 主任研究者：Pornanong Aramwit, Ph.D、Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn University

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 (予想される)

2021年11月1日

一次修了 (予想される)

2022年10月31日

研究の完了 (予想される)

2022年10月31日

試験登録日

最初に提出

2021年8月3日

QC基準を満たした最初の提出物

2021年8月3日

最初の投稿 (実際)

2021年8月10日

学習記録の更新

投稿された最後の更新 (実際)

2021年9月24日

QC基準を満たした最後の更新が送信されました

2021年9月20日

最終確認日

2021年9月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • Med Chula IRB 572/64

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

いいえ

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