Analgesic efficacy of an ibuprofenreleasing foam dressing compared with local best practice for painful exuding wounds

Journal of Wound Care

Volumn 20, Issue 7, 2011, Pages 319-325

  Arapoglou, V ^a   Katsenis, K ^a   Syrigos, K N ^b   Dimakakos, E P ^b   Zakopoulou, N ^c   Tsoutsos, D ^d   Gjodsbol K ^e   Glynn, C ^f   Schafer E ^g   Petersen, B ^e  

^a UNIVERSITY OF ATHENS   (Greece)

^b UNIVERSITY OF ATHENS MEDICAL SCHOOL   (Greece)

^c ANDREAS SYGROS HOSPITAL   (Greece)

^d G GENNIMATAS GENERAL HOSPITAL   (Greece)

^e Global R and D   (Denmark)

^f BMI Oxford Clinic   (United Kingdom)

^g Wound Centre   (Germany)

Author keywords

Analgesia; Ibuprofen; Wound dressing; Wound pain

Indexed keywords

IBUPROFEN; NONSTEROID ANTIINFLAMMATORY AGENT;

AGED; ARTICLE; CLINICAL TRIAL; FEMALE; HUMAN; INJURY; MALE; MULTICENTER STUDY; OCCLUSIVE DRESSING; PAIN; RANDOMIZED CONTROLLED TRIAL (TOPIC); REGRESSION ANALYSIS; SKIN ULCER; TOPICAL DRUG ADMINISTRATION;

ADMINISTRATION, TOPICAL; AGED; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; FEMALE; HUMANS; IBUPROFEN; MALE; OCCLUSIVE DRESSINGS; PAIN; RANDOMIZED CONTROLLED TRIALS AS TOPIC; REGRESSION ANALYSIS; SKIN ULCER; WOUNDS AND INJURIES;

EID: 79960545815     PISSN: 09690700     EISSN: None     Source Type: Journal    
DOI: 10.12968/jowc.2011.20.7.319     Document Type: Article

References (24)

1. Phillips, T., Stanton, B., Provan, A., Lew, R. A study of the impact of leg ulcerson quality of life: financial, social, and psychologic implications. J Am Acad Dermatol. 1994; 31: 1, 49-53. (Pubitemid 24198162)
2. Hofman, D., Ryan, T.J., Arnold, F. et al. Pain in venous leg ulcers. J Wound Care. 1997; 6: 5, 222-224.
3. Cooper, S.M., Hofman, D., Burge, S.M. Leg ulcers and pain: a review. Int J Low Extrem Wounds. 2003; 2: 4, 189-197.
4. Nemeth, K.A., Harrison, M.B., Graham, I.D., Burke, S. Pain in pure and mixed aetiology venous leg ulcers: a three-phase point prevalence study. J Wound Care. 2003; 12: 9, 336-340.
5. Gottrup, F., Jørgensen, B., Karlsmark, T. et al. Reducing wound pain in venous leg ulcers with Biatain Ibu: a randomized, controlled double-blind clinical investigation on the performance and safety. Wound Repair Regen. 2008; 16: 5, 615-625.
6. Domenech, R.P., Romanelli, M., Tsiftsis, D.D., et al. Effect of an ibuprofen-releasing foam dressing on wound pain: a real-life RCT. J Wound Care. 2008; 17: 8, 342-348.
7. Jørgensen, B., Friis, G.J., Gottrup, F. Pain and quality of life for patients with venous leg ulcers: proof of concept of the efficacy of Biatain-Ibu, a new pain reducing wound dressing. Wound Repair Regen. 2006; 14: 3, 233-239. (Pubitemid 43979251)
8. Moore, A., McQuay, H., Gavaghana, D. Deriving dichotomous outcome measures from continuous data in randomised controlled trials of analgesics. Pain. 1996; 66: 2-3, 229-237. (Pubitemid 26283992)
9. Li Wan Po, A., Petersen, B. How high should total pain-relief score be to obviate the need for analgesic re-medication in acute pain? Estimation using signal detection theory and individualpatient meta-analysis. J Clin Pharm Ther. 2006; 31: 2, 161-165.
10. Farrar, J.T., Young, J.P., Jr, LaMoreaux, L. et al. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain 2000; 94: 2, 149-158. (Pubitemid 33016608)
11. Farrar, J.T., Berlin, J.A., Strom, B.L. Clinically important changes in acute pain outcome measures: a validation study. J Pain Symptom Management 2003; 25: 5, 406-411. (Pubitemid 36506668)
12. Tubach, F., Ravaud, R., Baron, G. et al. Evaluation of clinically relevant changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement. Ann Rheum Dis. 2005; 64: 1, 29-33. (Pubitemid 40075270)
13. Moore, R.A., Straube, S., Paine, J. et al. Minimum efficacy criteria for comparisons between treatments using individual patient meta-analysis of acute pain trials: Examples of etoricoxib, paracetamol, ibuprofen, and ibuprofen/paracetamol combinations after third molar extraction. Pain. 2011; 152: 5, 982-989.
14. Declaration of Helsinki II as amended in Tokyo 2004. www.wma.net/en/ 30publications/10policies/b3/17c.pdf.
15. Council Directive 93f42fEEC of 14 June 1993 concerning medical devices, Version 2003-03-27.
16. International ISO standard. Clinical investigation of medical devices for human subjects, ISO/DIS 14155-1; 2003. Part 1 and Part 2.
17. Steffansen, B., Herping, S.P.K. Novel wound models for characterizing the effects of exudate levels on the controlled release of ibuprofen from foam dressings. Int J Pharm. 2008; 364: 1, 150-155.
18. Dworkin, R.H., Turk, D.C., Farrar, J.T. et al. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005; 113: 1-2, 9-19. (Pubitemid 40038441)
19. Cook, R.J., Sackett, D.L. The number needed to treat: a clinically useful measure of treatment effect. BMJ. 1995; 310: 6977, 452-454.
20. Sibbald, R.G., Coutts, P., Fierheller, M., Woo, K. A pilot (real-life) randomised clinical valuation of a pain-relieving foam dressing: (Ibuprofen foam versus local best practice). Int Wound J. 2007; 4: (Suppl. 1), 16-23. (Pubitemid 46535989)
21. Gottrup, F., Jørgensen, B., Karlsmark, T. et al. Less pain with Biatain-Ibu: Initial findings from a randomised controlled double-blind clinical investigation on painful venous leg ulcers. Int Wound J. 2007; 4: (Suppl.1), 24-34. (Pubitemid 46535992)
22. Angst, M.S., Brose, W.G., Dyck, J,B. The relationship between the visual analog pain intensity and pain relief scale changes during analgesic drug studies in chronic pain patients. Anesthesiology. 1999; 91: 34-41. (Pubitemid 29307334)
23. McQuay, H.J., Moore, R.A. Dose-response in direct comparisons of different doses of aspirin, ibuprofen and paracetamol (acetaminophen) in analgesic studies. Br J Clin Pharmacol. 2007; 63: 3, 271-278.
24. McQuay, H.J., Moore, R.A. Using numerical results from systematic reviews in clinical practice. Ann Internal Med. 1997; 126: 9, 712-720. (Pubitemid 27184043)