StudyReason excluded
Holistic assessment
Bianchetti et al., 1993The study’s main focus is on those subjects without ulcers but who are at risk of developing pressure ulcers.
Clarke and Kadhom, 1988Prevention study
Guralnik et al., 1988Prevention study
Berlowits and Wilkin, 1989Prevention study
Kemp et al., 1990Prevention study
Ek et al., 1991Prevention study
Marchette et al., 1991Prevention study
Bergstrom et al., 1992Prevention study
Rijswijk, 1993Study design and methods not clear. Poor methodology. No multivariate analysis of risk factors.
Hoshowsky and Schramm, 1994Prevention study
Brandeis et al., 1994Prevention study
Bergstron et al.,1996Prevention study
Schnelle et al., 1997Prevention study
Nixon et al., 2000Prevention study
Halfens et al., 2000Prevention study
Theaker et al., 2000Prevention study
Boyle and Green, 2001Prevention study
Schoonhoven et al., 2002Prevention study
Berquist, 2003Prevention study
Baumgarten et al., 2003Prevention study
Schoonhoven et al., 2003Prevention study
Ulcer assessment
Melhuish et al., 1994Not pressure ulcers
Gardner et al., 2001General chronic wound unclear what percentage were pressure ulcers.
Pressure-relieving surfaces
Bennett et al., 1998Prevention trial
Lazzara et al., 1991Prevention trial
Marchand et al.Prevention trial
Rosenthal et al., 1996Prevention trial
Stoneberg et al., 1986Prevention trial
Dressings and topical agents
Cheneworth, 1994Pressure sore prevention, not treatment.
Collier, 1992No data on healing - mentions ‘improved’.
Fowler, 1983No outcome data.
Gorse, 1987Not RCT. Patients allocated to wards to give a balance of surgical and medical patients, then one treatment used on each ward.
Isago, 2003Not RCT. Case series.
Kloth, 2000Not RCT. Control group was a convenience sample.
Lum, 1996Not RCT. Quasi randomised trial: patients with odd admission number were allocated to the control group, those with an even number were assigned to the treatment group.
Maas-Irslinger, 2003Not RCT. Controlled experiments on healthy volunteers.
Milward, 1995Evaluation of a skin treatment rather than wound dressing.
Mosher, 1999Not RCT. Decision analysis study.
Rhodes, 2001Quasi experimental design: unit of randomisation was physicians not patients or ulcers.
Oleske, 1986Quasi experimental design: unit of randomisation was nursing modules not patients or ulcers. Patients would receive the treatment assigned to the module.
Pierce, 1994Outcome data was electron microscopy results.
Pittl, 1995Conflicting results. Coloplast contacted for clarification - no reply.
Shutler, 1995No data on healing.
Smith, 1996Not RCT. A practice survey, excluded patients with pressure sores.
Shiraishi, 1997Not RCT. Pharmacological study.
Tytgat, 1988Not RCT. No objective outcomes measurement.
Vande Berg, 1995Outcome based on histology.
Wongworawat, 2003Not RCT. Case series.
Antimicrobials
Baker, 1981Before-after study.
Bendy, 1964No objective wound healing outcomes.
Gorse, 1987Unit of allocation was wards and this allocation was likely to produce heterogeneous treatment groups.
Hartman, 2002Not truly randomised. Some patients acted as their own controls. Used essential oils as antimicrobial agent.
Kucan, 1981Microbiological outcomes and subjective assessment of wounds the only outcomes available.
Nasar, 1982Some patients were additionally given systemic antibiotics, but insufficient details given regarding this co-intervention. Some patients crossed over between treatment groups.
Norton 1962The unit of allocation was wards and this allocation was likely to produce heterogeneous treatment groups.
Robson, 1991Growth factor and disaccharide preparation evaluated within two double blind, placebo controlled RCTS. For both trials, silver sulphadiazine was allocated to any additional ulcers in a non-randomised, un-blinded fashion.
Subramanian, 1990Separate data not available for chronic wounds. No objective wound healing outcomes.
Adjunct therapies
Canedo-Dorantes, 2002Not RCT, physiological study. Did not address treatment of pressure ulcers but chronic arterial and venous leg ulcers.
Elsberg, 2002Not RCT. Case series (n=8) with stage 3–4 pressure ulcers that showed no improvement after conventional treatment for 2 weeks. Treatments given were topical hyperbaric oxygen and electrical stimulation.
Rippon, 1999Not RCT. Experimentally induced wounds were monitored using pulse ultrasound over 21 days.
Selkowtiz, 2002Not RCT. Description of single case (patient with stage 3 pressure ulcer) different treatment administered at different time periods.
Argenta, 1997This study utilised TNP to treat 300 wounds, 175 of which were chronic. There was no control or comparison group therefore this is not a prospective RCT.
Banwell, 1998This study utilised TNP to treat 200 acute and chronic wounds. There was no control or comparison group therefore this is not a prospective RCT.
Das Gupta, 1996This study utilised TNP to treat 23 patients with chronic wounds. There was no control or comparison group therefore this is not a prospective RCT.
Deva, 2000This study utilised TNP to treat 30 patients with pressure ulcers who were judged to be unsuitable for reconstructive surgery. The study is not a prospective RCT, but a prospective, consecutive case series.
Fabian, 2000This study compared the healing of hypoxic full thickness ear wounds in rabbits (41) when treated with TNP or foam (not treated with TNP) and adhesive drape, with or without hyperbaric oxygen. This is a prospective RCT but not in humans.
Genecov, 1998This study compared the healing rate of donor site wounds in pigs (4) when treated with TNP or Opsite. It also compared the epithelialisation rates of donor site wounds in humans (10) when treated with TNP or Opsite, but looking at acute wounds.
Greer, 1999This study appeared to be a relevant RCT looking at the effect of TNP on pressure ulcer healing. The trial was terminated prematurely.(Personal communication KCI,USA)
Heath, 2002This study compared the percentage of epithelialisation in surgical wounds in humans (30) when treated with a skin graft plus TNP or standard pressure dressing. This appears to be a prospective controlled trial in humans but in acute wounds.
Heissing, 1995This study utilised either continous or variable TNP to treat 120 hip replacement patients. This is a prospective randomised controlled trial in humans but in acute wounds healing by primary intention.
Holmich, 1998This study utilised TNP to treat 14 patients with acute (5) or chronic (9) wounds. There was no control or comparison group therefore this is not a prospective RCT.
Isago, 2003Not an RCT. This study assessed the effect of negative pressure dressings on 10 patients with stage 4 pressure ulcers. There was no control group or random allocation of patients.
Ladin, 2000This study utilised TNP to treat 8 patients with diabetic foot ulcers, venous stasis ulcers or post traumatic ulcers. There was no control or comparison group therefore this is not a prospective RCT.
de Lange, 2000This study utilised TNP to treat 100 patients, 23 of which had 26 stage 4 pressure ulcers. There was no control or comparison group therefore this is not a prospective RCT.
McCallom, 2000This RCT assessed the effect of TPN on patients with diabetic foot ulcers, and not on pressure ulcers.
Mooney, 2000This study utilised TNP to treat 27 paediatric patients,16 of which had chronic extremity and axial wounds. There was no control or experimental group therefore this is not a prospective RCT.
Morykwas, 1993This study compared the healing rates of full thickness dorsal wounds in pigs (5) when treated with TNP or saline wet to moist dressings. This appears to be a prospective controlled trial on acute wounds and not in humans.
Morykwas, 1995This study retrospectively analysed the length of stay and total charges for 159 hospitalised patients with chronic wounds treated with either TNP (35) or other modalities (124) over a 21-month period. Patients were not randomly allocated to the two treatment groups.
Morykwas, 1997This series of studies of the effect of TNP on blood flow in the wound and adjacent tissue (5), the rate of granulation tissue formation (10), the clearance of bacteria from infected wounds (5) and the measurement of nutrient flow (5). These studies appear to be prospective controlled trials but on acute wounds and not in humans.
Mullner, 1997This study utilised TNP to treat 45 patients, 17 of whom had sacral pressure ulcers. There was no control or comparison group therefore this is not a prospective RCT.
Philbeck, 1995Retrospective analysis of wound healing, and from this estimated the financial cost, in 1,032 home healthcare patients with 1,170 chronic wounds, when treated with TNP. This group was compared with an historical control group that had been treated with saline-soaked gauze therefore this is not a prospective RCT.
Wu, 2000This study utilised TNP to treat 26 patients, 11 of whom had chronic wounds. There was no control or comparison group therefore this is not a prospective RCT.
Nutrition
Benati, 200136 patients with severe cognitive impairment and pressure ulcers were randomised into three intervention groups but no outcome data were reported.
Bergstrom, 1987129 institutionalised elderly, who were at risk but did not have pressure ulcers at admission, were studied to determine whether dietary and serum zinc and copper differ between those who developed pressure ulcers and those who did not.
Bourdel, 1997Retrospective case-control study with 108 patients to discover early and late tolerance of long-term feeding with PEG for older and frail patients. Not an RCT or CCT.
Breslow, 1990PHD thesis. Published report see Breslow, 1991.
Breslow, 1991Comparison of nutritional status and dietary intake of 14 tube fed nursing home patients with pressure ulcers to 12 tube fed patients without pressure ulcers. Not an RCT or CCT.
Breslow, 199328 malnourished patients with pressure sores received 24% protein or 14% protein supplements for a period of 8 weeks. First RCT, then CCT justified by unbalanced groups and high drop-out rate; effects of bed type on results are unclear.
Burr, 1972Not an RCT. Study assessed the leucocyte ascorbic acid concentration of 91 paraplegic patients on admission (33 of which had pressure sores) and 41 controls. 10 of the patients with pressure sores were given a course of ascorbic acid or placebo, but allocation to the treatments were not made at random.
Cruse, 2000Review of immune function, healing of pressure ulcers and nutritional status in patients with spinal cord injury. Not linked to pressure ulcers laboratory study of immune function and nutritional markers.
Gardner, 1999Literature review and meta-analysis of studies assessing the effect of electrical stimulation on chronic wound healing.
Gray, 2003Literature review article of vitamin C supplementation to promote pressure ulcer healing.
Gray, 2003Literature review article of oral zinc supplementation to promote healing of chronic wounds.
Gray, 2003Literature review article of supplementation of vitamin A or E to promote healing of chronic wounds.
Henderson, 1992This study examined the nutritional status and clinical outcomes including pressure ulcers and death in 40 tube fed patients. Not linked to pressure ulcer healing.
Jackobs, 199913 patients in long-term care with grade 2 or 3 pressure ulcers were included in this study to evaluate the cost of nutrition therapy to heal pressure ulcers. Not a randomised or controlled clinical trial. Diet regimes were allocated according to pressure ulcer stage. Main outcomes reported were economic.
Langkamp Henken, 200032 nursing home residents with pressure ulcers received 0g, 8.5 g or 17 g arginine for 4 weeks. Not pressure ulcers but only immune functions were measured.
Lawson, 2003Studied the effect of unselected post- operative nutritional supplementation on nutritional status and clinical outcome of orthopaedic patients. Not pressure ulcers.
Larsson, 1990501 geriatric patients received standard hospital diet or additional nutritional supplements for 26 weeks. Pressure ulcers not measured.
Lewis, 1996A literature review of protein levels and the aetiology of pressure sores.
Myers, 199080 patients with pressure ulcers were treated with wound care, with nutritional support, with both or with standard hospital treatment for 7 days. Nutritional supplementation was not clearly described.
North, 1999Systematic review of studies that compared the impact of oral or enteral supplements of Vitamin C on the rate of healing of pressure sores. The review included other systematic reviews, randomised trials, quazi-exerimental studies and nonexperimental studies.
Prescott, 2003Expert opinion paper with literature review. Abstract notes that five RCTs have been conducted to assess the effect of zinc supplementation on the healing of pressure ulcers, but the five trials referred to all assessed the effect of zinc supplementation in healing venous leg ulcers.
Rypkema, 2004298 older patients in a prospective controlled study. Randomisation was wards. Not pressure ulcer healing.
Senapati, 1989Not an RCT. A physiological study assessing plasma zinc levels in elderly patients with leg, sacral or gluteal decubitus ulcers, and three groups of different types of control patients.
Thomas, 2001Literature review of nutritional interventions to improve outcomes for people with pressure ulcers.
Mobility and positioning
Defloor, 1999Not RCT
Defloor, 2000Not RCT
Defloor, 2000Prevention trial
Defloor, 2001Interface pressure outcome
Surgery
Arregui et al., 1965Retrospective chart review
Aydan et al., 2003Retrospective chart review
Brucks et al., 1991Animal study
Chan et al., 2003Retrospective chart review
Gusenoff, 2002Retrospective chart review
Higins et al., 2002Single case report
Hollis, 1979Single case report
Inoue, 19902 subjects only
Patel and Kuzon, 2001Single case report
Rubayi, 1999Retrospective review
Thomson et al., 20014 subjects only

From: Appendix D, Table of excluded studies

Cover of The Management of Pressure Ulcers in Primary and Secondary Care
The Management of Pressure Ulcers in Primary and Secondary Care: A Clinical Practice Guideline [Internet].
NICE Clinical Guidelines, No. 29.
Royal College of Nursing (UK).
London: Royal College of Nursing (UK); 2005 Sep 22.
Copyright © 2005, Royal College of Nursing.

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