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Healing by Secondary Intention

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1821. Sodium carboxyl-methyl-cellulose dressings in the management of deep ulcerations of diabetic foot. (PubMed)

-epithelialization. Ulcers were all left to heal by secondary intent. After 8 weeks patients were blindly evaluated for: the rate of reduction of lesional volume (RLV), rate of granulation tissue (GT), number of infective complications (IC). Intralesional (ILTC) and perilesional (PLTC) temperatures were also recorded with a thermocouple surface digital thermometer, and the difference between the two values (Delta TC) was calculated. Healing time (HT, days), was then compared between the two groups. Data were (...) supply (palpable peripheral pulses or ABPI > 0.9). Exclusion criteria were as follows: active infection, as evident from clinical signs (purulent discharge, redness, swelling, tenderness) and confirmed by culture exams, plasma creatinine > 2 mg/dl, recent episodes of ketoacidosis, malignancies, and any therapy or pathology which might interfere with the healing process. Twenty patients were enrolled in the study and having obtained their informed consent, their lesions were surgically debrided

2001 Diabetic medicine : a journal of the British Diabetic Association Controlled trial quality: uncertain

1822. Randomized trial of low-dose misoprostol and naproxen vs. nabumetone to prevent recurrent upper gastrointestinal haemorrhage in users of non-steroidal anti-inflammatory drugs. (PubMed)

presenting with upper gastrointestinal bleeding were enrolled if they required long-term NSAIDs. After ulcer healing, they were randomized to receive: naproxen (500-1000 mg/day) and misoprostol (200 microg b.d.), or nabumetone (1000-1500 mg/day) and placebo misoprostol for 24 weeks. The primary end-point was recurrent upper gastrointestinal bleeding. The secondary end-point was the proportion of patients suffering from major gastrointestinal events including ulcer bleeding, symptomatic ulcers and severe (...) Randomized trial of low-dose misoprostol and naproxen vs. nabumetone to prevent recurrent upper gastrointestinal haemorrhage in users of non-steroidal anti-inflammatory drugs. Prophylactic misoprostol or non-steroidal anti-inflammatory drugs (NSAIDs) with low gastric toxicity (nabumetone) has been shown to reduce mucosal injury.To compare nabumetone vs. co-therapy of naproxen with low-dose misoprostol for secondary prevention of upper gastrointestinal bleeding in NSAID users.NSAID users

2001 Alimentary pharmacology & therapeutics Controlled trial quality: predicted high

1823. Two randomised and placebo-controlled studies of an oral prostacyclin analogue (Iloprost) in severe leg ischaemia. The Oral Iloprost in severe Leg Ischaemia Study Group. (PubMed)

treatment groups: placebo, low dose Iloprost (50-100 microgram twice a day) or high dose (150-200 microgram twice a day) In Study A the main outcome measures were tolerability of different doses of Iloprost and death, major amputation, healing of trophic lesions and relief of rest pain at the end of the follow up, which was 5 months after the end of the treatment. In Study B the primary end point was time to major amputation and stroke or death up to 12 months. Secondary pre-defined end points included (...) the combined end point of patients alive without amputation, no trophic skin changes, no rest pain and not on regular analgesics.the proportion of patients who completed the 4-week treatment period in Study A at the intended dose was 58%, 43%, 45% respectively in the placebo, low dose and high dose Iloprost groups. In an intention to treat analysis the proportion of patients who survived without major amputation, ulcers or gangrene and had no rest pain was 11% in the placebo group, 19% in the low dose

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2000 European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery Controlled trial quality: predicted high

1824. Cost benefits of two dressings in the management of surgical wounds. (PubMed)

Cost benefits of two dressings in the management of surgical wounds. In this prospective randomized controlled trial of the cost benefits of the choice of dressings in acute surgical wounds left to heal by secondary intention, patients had their wounds dressed with either a traditional dressing (ribbon gauze soaked in proflavine) or a modern hydrofibre dressing. Results showed that the hydrofibre dressing, although more expensive than the ribbon gauze, facilitated an earlier discharge from

2002 British journal of nursing (Mark Allen Publishing) Controlled trial quality: uncertain

1825. Esomeprazole (40 mg) compared with lansoprazole (30 mg) in the treatment of erosive esophagitis. (PubMed)

Esomeprazole (40 mg) compared with lansoprazole (30 mg) in the treatment of erosive esophagitis. Esomeprazole, the S isomer of omeprazole, has been shown to have higher healing rates of erosive esophagitis than omeprazole. This study compared esomeprazole with lansoprazole for the healing of erosive esophagitis and resolution of heartburn.This United States multicenter, randomized, double blind, parallel group trial was performed in 5241 adult patients (intent-to-treat population (...) ) with endoscopically documented erosive esophagitis, which was graded by severity at baseline (Los Angeles classification). Patients received 40 mg of esomeprazole (n = 2624) or 30 mg of lansoprazole (n = 2617) once daily before breakfast for up to 8 wk. The primary efficacy endpoint was healing of erosive esophagitis at week 8. Secondary assessments included proportion of patients healed at week 4, resolution of investigator-recorded heartburn, time to first and time to sustained resolution of patient diary

2002 The American journal of gastroenterology Controlled trial quality: predicted high

1826. A comparison of hydrofibre and alginate dressings on open acute surgical wounds. (PubMed)

A comparison of hydrofibre and alginate dressings on open acute surgical wounds. This study aimed to compare the performance of a hydrofibre (Aquacel) and an alginate (Sorbsan) dressing on acute surgical wounds left to heal by secondary intention. A total of 100 patients were prospectively randomised pre-operatively to receive either the hydrofibre or the alginate dressing. Dressing performance was measured at operation, at 24 hours and seven days. Parameters measured included ease

2000 Journal of wound care Controlled trial quality: uncertain

1827. Prospective randomized double-blind study of the wound-debriding effects of collagenase and fibrinolysin/deoxyribonuclease in pressure ulcers. (PubMed)

-blind trial. Patients were treated until complete wound debridement or for a maximum of 4 weeks with twice-daily applications of collagenase or fibrinolysin/deoxyribonuclease. The primary endpoint was percentage change in the yellow or black wound surface. Secondary endpoints were wound environment, margins, depth, pocketing, area and healing. Assessment was by two independent dermatologists who were unaware of the treatment administered and evaluated results from photographs taken at the beginning (...) and end of treatment.on intention-to-treat analysis, collagenase gave slightly better results with regard to the primary endpoint in the 121 assessable patients, but this difference was not statistically significant (P=0.115). Additional efficacy measures did not show any statistically significant difference between the groups.there was no evidence of a difference between collagenase and fibrinolysin/deoxyribonuclease in the debridement of pressure ulcers.

2002 Age and ageing Controlled trial quality: uncertain

1828. Wound management after colon injury: open or closed? A prospective randomized trial. (PubMed)

Wound management after colon injury: open or closed? A prospective randomized trial. It is unknown whether leaving the skin wound open to heal by secondary intention is associated with a lower rate of wound infections compared with primary skin-wound closure after operations for colon injuries. From June 1998 to December 2000 at our Level I academic trauma center 48 patients entered into a randomized controlled trial (RCT) and were randomized to have their skin wound primarily closed (CLOSED

2002 The American surgeon Controlled trial quality: predicted high

1829. Bevacizumab Plus Fluorouracil and Leucovorin in Treating Patients With Locally Advanced or Metastatic Stage IV Colorectal Cancer That Has Progressed After Standard Chemotherapy

agents No active infection No psychiatric illness or social situation that would preclude study compliance No serious nonhealing wound (including wounds healing by secondary intention), ulcer, or bone fracture No CNS disease, including either of the following: Primary brain tumor Seizures not controlled with standard medical therapy PRIOR CONCURRENT THERAPY: Biologic therapy At least 8 weeks since prior monoclonal antibody therapy No prior bevacizumab Chemotherapy See Disease Characteristics

2003 Clinical Trials

1830. Gefitinib in Treating Patients With Stage IB, II, or IIIA Non-small Cell Lung Cancer That Was Completely Removed by Surgery

Stage IIIA Non-small Cell Lung Cancer Drug: gefitinib Other: placebo Other: laboratory biomarker analysis Phase 3 Detailed Description: PRIMARY OBJECTIVES: I. To assess, in comparison with placebo, the impact of adjuvant therapy with two years of daily oral ZD1839 (IRESSA) (gefitinib) on the overall survival of patients with completely resected (T1N1-2, T2N0-2, T3N0-2) non-small cell lung cancer (NSCLC). SECONDARY OBJECTIVES: I. To compare the disease-free survival in the placebo arm to the ZD1839 (...) will be described by the Kaplan-Meier method. A stratified log-rank test will be used as the primary method to compare the overall survival between two arms adjusting for the stratification factors. An unadjusted analysis will also be performed. Five years survival rate will be reported. Secondary Outcome Measures : Disease Free Survival [ Time Frame: From randomization to the time of documented recurrence of the primary cancer, assessed up to 5 years ] The survival experience of patients in both treatment

2002 Clinical Trials

1831. Combination Chemotherapy and Bevacizumab in Treating Patients With Locally Advanced, Metastatic, or Recurrent Colorectal Cancer

primarily by the stratified Cox model. Secondary Outcome Measures : Time to treatment failure [ Time Frame: Up to 6 years ] Will be analyzed primarily by the Cox stratified model. Progression-free survival [ Time Frame: Up to 6 years ] Will be analyzed primarily by the Cox stratified model. Response (among patients with measurable disease) [ Time Frame: Up to 6 years ] Will be analyzed primarily by the Cox stratified model. Treatment toxicities graded according to National Cancer Institute (NCI) Common (...) this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Layout table for eligibility information Ages Eligible for Study: 18 Years and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Histologically or cytologically confirmed locally advanced, recurrent, or metastatic colorectal adenocarcinoma Not curable by surgery or amenable to radiotherapy with curative intent

2003 Clinical Trials

1832. A Phase I, Pharmacological, and Biological Study of OSI-774 in Combination With FOLFOX 4 (5-FU, Leucovorin, and Oxaliplatin) and Bevacizumab (Avastin) in Patients With Advanced Colorectal Cancer

) of OSI-774 given in combination with FOLFOX 4 and Bevacizumab, in patients with advanced colorectal cancer. II. To characterize the toxicity profile of this regimen. III. To explore the antitumor activity of this combination. SECONDARY OBJECTIVES: I. To characterize the pharmacokinetics of OSI-774 given with FOLFOX 4, and Bevacizumab. II. To determine the relationship between CYP3A4 activity and OSI-774 clearance. III. To correlate Cytochrome P450 activity with OSI-774 PK using midazolam clearance (...) will be calculated using the total number of patients enrolled in an intent to treat analysis. Overall survival [ Time Frame: Up to 12 months ] Will be estimated using the Kaplan-Meier method and will be displayed graphically. Median overall survival and confidence limits will be determined. Kaplan-Meier estimates of survival at 6 and 12 months and their standard errors will be calculated. Progression-free survival [ Time Frame: Up to 12 months ] Progression-free survival will be estimated using the Kaplan-Meier

2003 Clinical Trials

1833. Improved management of the perineal wound after proctectomy. (PubMed)

, which was also drained by suction catheters brought out through the lower abdominal wall. The skin and subcutaneous tissues were allowed to heal by secondary intention in seven patients who had excessive preoperative perineal sepsis from fistulas, deep fissures, and abscesses. All seven wounds healed within 2 months. Of the other 50 patients, whose wounds were closed to the skin, 48 were discharged with completely healed perineal wounds. Two patients had sterile pelvic hematomas that drained through (...) Improved management of the perineal wound after proctectomy. In an effort to avoid the failures of perineal wound healing that are common after proctectomy, 57 patients who had abdominoperineal resection of the rectum or total proctocolectomy for ulcerative colitis (35 patients), Crohn's colitis (12), or carcinoma (10) had primary closure of the levator muscles and perineal tissues. No attempt was made to approximate the pelvic peritoneum. The small bowel was allowed to fill the pelvic space

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1985 Annals of Surgery

1834. Omeprazole in Peptic Ulcer Bleeding: IV PPI for GI bleeds

=120) Placebo (n=120) Setting: Prince of Wales Hospital, Chinese University of Hong Kong Enrollment: May 1998 to July 1999 Analysis: Intention-to-treat Population Inclusion Criteria Age ≥16 years Admitted with upper gastrointestinal bleeding Underwent endoscopy <24 hours after admission Actively bleeding ulcers or ulcers with nonbleeding visible vessels Exclusion Criteria Ulcers with clean bases or flat pigments did not receive endoscopic treatment Unsuccessful endoscopic treatment with profuse (...) . 22.5% (RR 0.30; P<0.001) Actively bleeding ulcers 4.7% vs. 17.2% (RR 0.27; P=0.04) Ulcers with nonbleeding visible vessels 8.9% vs. 27.4% (RR 0.32; P=0.02) Recurrent bleeding by day 3 4.2% vs. 20% (RR 0.21; P<0.001) Recurrent bleeding by day 7 5.8% vs. 21.7% (RR 0.27; P<0.001) Secondary Outcomes Required surgery 2.5% vs. 7.5% (RR 0.33; P=0.14) Median hospital stay <5 days 46.7% vs. 31.7% (RR 1.5; P=0.02) Duration of hospitalization (median) 4 vs. 5 (P=0.006) Units of blood transfused 2.7 vs. 3.5 (P

2000 Wiki Journal Club

1835. Clopidogrel versus acetylsalicylic acid for the secondary prevention of vascular diseases

ulcers/erosions under ASA (Chan 2005: bleeding; Ng 2004: bleeding or dyspepsia), a switch to clopidogrel reduced the risk of recurrent bleeding or increased the healing rate of ulcers. Due to major methodological deficiencies, no valid Final report A04-01A: Clopidogrel versus ASA for secondary prevention of vascular diseases 7 conclusions can be drawn from the Ng trial. The Chan trial also showed major deficiencies. However, under consideration of the additional information supplied by the main (...) Clopidogrel versus acetylsalicylic acid for the secondary prevention of vascular diseases Clopidogrel versus acetylsalicylic acid for the secondary prevention of vascular diseases 1 - Final report - [Commission No. A04-01A] 1 Publication date of the English translation: 04 October 2006. This translation is based on the German final report “Clopidogrel versus Acetylsalicylsäure in der Sekundärprophylaxe vaskulärer Erkrankungen” (Version 1.0, 30 June 2006). Please note: The translation

2006 Institute for Quality and Efficiency in Healthcare (IQWiG)

1836. Clinical practice guideline: The use of pressure-relieving devices (beds, mattresses and overlays) for the prevention of pressure ulcers in primary and secondary care

Clinical practice guideline: The use of pressure-relieving devices (beds, mattresses and overlays) for the prevention of pressure ulcers in primary and secondary care clinical practice guidelines National Collaborating Centre for Nursing and Supportive Care Guidelines commissioned by the National Institute for Clinical Excellence First published October 2003 Reprinted January 2005 The use of pressure-relieving devices (beds, mattresses and overlays) for the prevention of pressure ulcers (...) in primary and secondary care1 The use of pressure- relieving devices (beds, mattresses and overlays) for the prevention of pressure ulcers in primary and secondary care Guidelines commissioned by the National Institute for Clinical Excellence Published by the Royal College of Nursing, 20 Cavendish Square, London W1G 0RN First published October 2003 Reprinted January 2005 Publication code: 002 444 ISBN: 1-904114-12-1 © 2005 Royal College of Nursing. All rights reserved. No part of this publication may

2007 Royal College of Nursing

1837. The effectiveness of digital imaging and remote expert wound consultation on healing rates in chronic lower leg ulcers in the Kimberley region of Western Australia

the time horizon of the trial (i.e. 1 year). No losses to follow-up were reported in the paper. Analysis of effectiveness It was not stated whether the analysis of the clinical study was conducted on an intention to treat basis or for treatment completers. The effectiveness outcomes reported were the mean healing rate differences between the study groups, and the number of amputations and number of deaths occurring in each group. The healing rates were calculated by determining the percentage decrease (...) imaging and remote expert wound consultation on healing rates in chronic lower leg ulcers in the Kimberley region of Western Australia. Primary Intention 2004; 12(2): 62-70 Other publications of related interest Schonfeld WH, Villa KF, Fastenau JM, et al. An economic assessment of Apilgraf (Graftskin) for the treatment of hard-to-heal venous leg ulcers. Wound Repair & Regeneration 2000;8:251-7. Haughton PE, Kincaide CB, Lovell M, et al. Effects of electrical stimulation on chronic leg ulcer size

2004 NHS Economic Evaluation Database.

1838. Healing pressure ulcers with collagen or hydrocolloid: a randomized, controlled trial

blinded to the treatment assignment. Analysis of effectiveness The analysis of effectiveness was conducted on an intention to treat basis. The primary health outcome was the proportion of ulcers healed within 8 weeks of randomisation. The secondary outcomes were the area healed per day and linear healing of the wound edge. Efficacy was assessed using ulcer photography. There were no significant differences between the groups at baseline, although this might have been because of a lack of power (...) to detect such differences. The authors acknowledged that ulcer duration and area appeared different at baseline. Effectiveness results The healing rate was 51% in the collagen group and 50% in the hydrocolloid group. This gave a difference in healing rates of 1% (95% confidence interval: -26 - 29; p=0.893). The secondary outcomes were not significantly different, (p>0.5). There were no adverse events that were judged to be related to the study interventions. Clinical conclusions The authors concluded

2003 NHS Economic Evaluation Database.

1839. Negative pressure wound therapy for wound healing

wound therapy (NPWT) is a treatment for acute and chronic wounds that involves the application of subatmospheric pressure to the open wound with the goal of creating a controlled, closed wound amenable to surgical closure, grafting, or healing by secondary intention. NPWT is intended as an adjunct treatment for the healing of nonhealing or slow healing acute or chronic wounds that are refractory to standard treatment. Final publication URL The report may be purchased from: Indexing Status Subject (...) Negative pressure wound therapy for wound healing Negative pressure wound therapy for wound healing Negative pressure wound therapy for wound healing HAYES, Inc. Record Status This is a bibliographic record of a published health technology assessment. No evaluation of the quality of this assessment has been made for the HTA database. Citation HAYES, Inc.. Negative pressure wound therapy for wound healing. Lansdale: HAYES, Inc.. Directory Publication. 2007 Authors' objectives Negative pressure

2007 Health Technology Assessment (HTA) Database.

1840. Wound-healing technologies: low-level laser and vacuum-assisted closure

healing as the primary endpoint; adjustment for confounders; and intention-to-treat analysis. Sample sizes were generally small, making it difficult to find statistically significant differences between groups. The best available trial did not show a higher probability of complete healing at 6 weeks with the addition of low-level laser compared to sham laser treatment added to standard care. Study weaknesses were unlikely to have concealed existing effects. Future studies may determine whether (...) different dosing parameters or other laser types may lead to different results. Vacuum-assisted closure trials did not find a significant advantage for the intervention on the primary endpoint, complete healing, and did not consistently find significant differences on secondary endpoints and may have been insufficiently powered to detect differences. Ongoing RCT protocols may provide better evidence on outcomes of interest. Given the sparse evidence for these two interventions, at the present time

2004 Health Technology Assessment (HTA) Database.

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