Risk Factors for Pressure Ulcers
Case Control Study of the Risk Factors for Pressure Ulcers in Tunisian Patients
調査の概要
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
-
Sousse、チュニジア、4000
- Latifa KHLIFI
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- presenting with at least of a wound and confirmed diagnosis of PU, age≥18 years old, bedridden, not feeds only and without trophic and mental disorders.
Exclusion Criteria:
- paediatric study populations, age > 90 years old, allergy to wound products, malignant origin
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 観測モデル:ケースコントロール
- 時間の展望:回顧
コホートと介入
グループ/コホート |
介入・治療 |
---|---|
100 patients suffering from pressure ulcer
100 subjects were having at least one wound of pressure ulcer (74 men and 26 women) middle-aged (55.5±20 years) and were recruited from many services of three University Regional hospitals of Tunisia.
|
|
213 healthy subjects
213 healthy subjects (125 men and 88 women) middle-aged (51.5±17 years).
Although, healthy individuals, were included as controls, followed in the outpatient services of the University Hospital Farhat Hached and they considered clinically free of pressure ulcer and tissue necrosis.
|
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 |
---|---|---|
Anthropometric characteristics
時間枠:one hour
|
Body Mass Index (BMI) is a simple index of weight-for-height.
It is defined as the weight in kilograms divided by the square of the height in metres (kg/m2).
|
one hour
|
Diabetes mellitus
時間枠:one hour
|
- Plasma levels glucose in mmol/l was measured by standard enzymatic methods using reagents in a fully automated analyzer Cx5 Pro-Bechman Coulter-Fuller-Ton
|
one hour
|
Dyslipidemia
時間枠:one hour
|
|
one hour
|
Renal failure
時間枠:one hour
|
- renal profile: urea (mmol/l), creatinine and uric acid (μmol/l) levels were measured by standard enzymatic methods using reagents in a fully automated analyzer ( Cx9 Pro-Bechman Coulter-Fuller-Ton).
|
one hour
|
Inflammatory parameter
時間枠:one hour
|
- C-reactive protein (CRP), in mg/l, was measured using immunoturbidimetric methods (COBAS INTEGRA 400 Roche).
|
one hour
|
Endogenous inflammatory marker
時間枠:one hour
|
- α1-acid glycoprotein, in g/l, measured using the dry chemistry method (BN prospec, siemens)
|
one hour
|
Markers of nutritional status
時間枠:one hour
|
|
one hour
|
Marker of lipid peroxidation
時間枠:one day
|
|
one day
|
Antioxidant parameters
時間枠:one day
|
- Serum catalase activity in KU/l was determined according to the spectrophotometric method of Goth .
|
one day
|
Total antioxidant status
時間枠:one hour
|
Serum total antioxidant status in mmol/l was measured with RANDOX kit (Cat.
No. NZ 2332; Randox Labs Ltd., Crumlin, UK) by colorimetric method at 600 nm .
|
one hour
|
Determination of trace elements
時間枠:one hour
|
Serum copper in μmol/l was indicated spectrophotometrically with RANDOX kit (Cat. No. CU 2340; Randox Labs Ltd., Crumlin, UK) at 580 nm according. Serum zinc was measured in μmol/l with RANDOX kit (Cat. No. ZN 2341; Randox Labs Ltd, Crumlin, UK) at 560 nm. |
one hour
|
Nutritional status
時間枠:3 hours
|
- Nutritional Risk Index (NRI) was originally derived from the serum albumin concentration and the ratio of present to usual weight [NRI = (1.489
x albumin, g/L) + (41.7 x present weight/ideal body weight)] and categorized as follows: severe risk (NRI < 83.5), moderate risk (83.5 < NRI < 97.5) and no risk (NRI > 97.5).
|
3 hours
|
Nutritional risk
時間枠:3 hours
|
- Prognostic Inflammatory and Nutritional Index (PINI) is a simple clinical [PINI = AAG x CRP / albumine x prealbumin] and classificated as follows: normal (1<PINI score <10), mild malnutrition (11<PINI score<20), severe malnutrition (21<PINI score<30) and risk for death when PINI score >30. These scores gained in popularity as it uses an objective rather than subjective measurements to determine nutritional risk in hospitalized patient populations. |
3 hours
|
A microbiological diagnosis
時間枠:3 days
|
The bacterial colonization of a wound is a recognized detrimental factor in the multifactorial process of wound healing. wound per patient suffering from pressure ulcer was cultured by swab to determine the bacterial species of the infection and helps guide antibiotic therapy. The representative sample is collected before topical or systemic antibiotics are initiated and pain assessment should be conducted prior to wound procedures such as dressing changes and debridement. Bacterial swabs provide information on the predominant flora. |
3 days
|
Proteomics
時間枠:2 days
|
- Serum gelatinase activities of MMP-9 by zymography (%)
|
2 days
|
DNA extraction
時間枠:2 days
|
Genomic DNA was extracted from whole blood using the salting out method for the part of molecular biology.
|
2 days
|
Genotype for the MMP9-1562 C/T polymorphism
時間枠:1 days
|
|
1 days
|
Genotyping of TNF- α G238A
時間枠:1 days
|
|
1 days
|
Genotyping of TNF- α G308A
時間枠:1 days
|
|
1 days
|
協力者と研究者
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- CHU Farhat Hached
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。