Clinically relevant pain relief with an ibuprofen-releasing foam dressing

results from a randomized, controlled, double-blind clinical trial in exuding, painful venous leg ulcers

Karsten Fogh, Maibritt B Andersen, Morten Bischoff-Mikkelsen, Renzo Bause, Markus Zutt, Stephan Schilling, Jean-Luc Schmutz, Jesús Borbujo, Juan A Jimenez, Hugues Cartier, B Jørgensen

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Resumé

The objective of this 6-week, 120-patient, double-blind, randomized, controlled trial was to investigate if a foam dressing with ibuprofen provided clinically relevant pain relief (PAR) for exuding, painful venous leg ulcers in comparison with a similar foam dressing without ibuprofen. Primary outcome parameter was PAR compared with baseline pain during the first 5 days of the investigation. PAR was registered by the patient morning and evening. Main end point was proportion of patients reporting a summed PAR score of at least 50% of the total maximum PAR (i.e., responders) and the corresponding number needed to treat (NNT). Wound-related parameters such as ulcer healing, ulcer area reduction, and peri-ulcer skin condition as well as adverse events were recorded during all 6 weeks of the investigation. PAR was significantly greater in the ibuprofen foam group than the comparator group (p = 0.0438). There were 34% responders in the ibuprofen foam group vs. 19% in the comparator group (NNT = 6.8). When evening data were analyzed separately to evaluate PAR over daytime, NNT was 5.3. Wound healing parameters and adverse events were comparable. In conclusion, in this study, the ibuprofen foam dressing provided clinically relevant PAR for patients with exuding, painful venous ulcers.
OriginalsprogEngelsk
TidsskriftWound Repair and Regeneration
Vol/bind20
Udgave nummer6
Sider (fra-til)815-21
Antal sider7
ISSN1067-1927
DOI
StatusUdgivet - 30. okt. 2012

Fingeraftryk

Varicose Ulcer
Leg Ulcer
Ibuprofen
Clinical Trials
Numbers Needed To Treat
Ulcer
Skin Ulcer
Randomized Controlled Trials

Citer dette

Fogh, Karsten ; Andersen, Maibritt B ; Bischoff-Mikkelsen, Morten ; Bause, Renzo ; Zutt, Markus ; Schilling, Stephan ; Schmutz, Jean-Luc ; Borbujo, Jesús ; Jimenez, Juan A ; Cartier, Hugues ; Jørgensen, B. / Clinically relevant pain relief with an ibuprofen-releasing foam dressing : results from a randomized, controlled, double-blind clinical trial in exuding, painful venous leg ulcers. I: Wound Repair and Regeneration. 2012 ; Bind 20, Nr. 6. s. 815-21.
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title = "Clinically relevant pain relief with an ibuprofen-releasing foam dressing: results from a randomized, controlled, double-blind clinical trial in exuding, painful venous leg ulcers",
abstract = "The objective of this 6-week, 120-patient, double-blind, randomized, controlled trial was to investigate if a foam dressing with ibuprofen provided clinically relevant pain relief (PAR) for exuding, painful venous leg ulcers in comparison with a similar foam dressing without ibuprofen. Primary outcome parameter was PAR compared with baseline pain during the first 5 days of the investigation. PAR was registered by the patient morning and evening. Main end point was proportion of patients reporting a summed PAR score of at least 50{\%} of the total maximum PAR (i.e., responders) and the corresponding number needed to treat (NNT). Wound-related parameters such as ulcer healing, ulcer area reduction, and peri-ulcer skin condition as well as adverse events were recorded during all 6 weeks of the investigation. PAR was significantly greater in the ibuprofen foam group than the comparator group (p = 0.0438). There were 34{\%} responders in the ibuprofen foam group vs. 19{\%} in the comparator group (NNT = 6.8). When evening data were analyzed separately to evaluate PAR over daytime, NNT was 5.3. Wound healing parameters and adverse events were comparable. In conclusion, in this study, the ibuprofen foam dressing provided clinically relevant PAR for patients with exuding, painful venous ulcers.",
author = "Karsten Fogh and Andersen, {Maibritt B} and Morten Bischoff-Mikkelsen and Renzo Bause and Markus Zutt and Stephan Schilling and Jean-Luc Schmutz and Jes{\'u}s Borbujo and Jimenez, {Juan A} and Hugues Cartier and B J{\o}rgensen",
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Clinically relevant pain relief with an ibuprofen-releasing foam dressing : results from a randomized, controlled, double-blind clinical trial in exuding, painful venous leg ulcers. / Fogh, Karsten; Andersen, Maibritt B; Bischoff-Mikkelsen, Morten; Bause, Renzo; Zutt, Markus; Schilling, Stephan; Schmutz, Jean-Luc; Borbujo, Jesús; Jimenez, Juan A; Cartier, Hugues; Jørgensen, B.

I: Wound Repair and Regeneration, Bind 20, Nr. 6, 30.10.2012, s. 815-21.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - Clinically relevant pain relief with an ibuprofen-releasing foam dressing

T2 - results from a randomized, controlled, double-blind clinical trial in exuding, painful venous leg ulcers

AU - Fogh, Karsten

AU - Andersen, Maibritt B

AU - Bischoff-Mikkelsen, Morten

AU - Bause, Renzo

AU - Zutt, Markus

AU - Schilling, Stephan

AU - Schmutz, Jean-Luc

AU - Borbujo, Jesús

AU - Jimenez, Juan A

AU - Cartier, Hugues

AU - Jørgensen, B

N1 - © 2012 by the Wound Healing Society.

PY - 2012/10/30

Y1 - 2012/10/30

N2 - The objective of this 6-week, 120-patient, double-blind, randomized, controlled trial was to investigate if a foam dressing with ibuprofen provided clinically relevant pain relief (PAR) for exuding, painful venous leg ulcers in comparison with a similar foam dressing without ibuprofen. Primary outcome parameter was PAR compared with baseline pain during the first 5 days of the investigation. PAR was registered by the patient morning and evening. Main end point was proportion of patients reporting a summed PAR score of at least 50% of the total maximum PAR (i.e., responders) and the corresponding number needed to treat (NNT). Wound-related parameters such as ulcer healing, ulcer area reduction, and peri-ulcer skin condition as well as adverse events were recorded during all 6 weeks of the investigation. PAR was significantly greater in the ibuprofen foam group than the comparator group (p = 0.0438). There were 34% responders in the ibuprofen foam group vs. 19% in the comparator group (NNT = 6.8). When evening data were analyzed separately to evaluate PAR over daytime, NNT was 5.3. Wound healing parameters and adverse events were comparable. In conclusion, in this study, the ibuprofen foam dressing provided clinically relevant PAR for patients with exuding, painful venous ulcers.

AB - The objective of this 6-week, 120-patient, double-blind, randomized, controlled trial was to investigate if a foam dressing with ibuprofen provided clinically relevant pain relief (PAR) for exuding, painful venous leg ulcers in comparison with a similar foam dressing without ibuprofen. Primary outcome parameter was PAR compared with baseline pain during the first 5 days of the investigation. PAR was registered by the patient morning and evening. Main end point was proportion of patients reporting a summed PAR score of at least 50% of the total maximum PAR (i.e., responders) and the corresponding number needed to treat (NNT). Wound-related parameters such as ulcer healing, ulcer area reduction, and peri-ulcer skin condition as well as adverse events were recorded during all 6 weeks of the investigation. PAR was significantly greater in the ibuprofen foam group than the comparator group (p = 0.0438). There were 34% responders in the ibuprofen foam group vs. 19% in the comparator group (NNT = 6.8). When evening data were analyzed separately to evaluate PAR over daytime, NNT was 5.3. Wound healing parameters and adverse events were comparable. In conclusion, in this study, the ibuprofen foam dressing provided clinically relevant PAR for patients with exuding, painful venous ulcers.

U2 - 10.1111/j.1524-475X.2012.00844.x

DO - 10.1111/j.1524-475X.2012.00844.x

M3 - Journal article

VL - 20

SP - 815

EP - 821

JO - Wound Repair and Regeneration

JF - Wound Repair and Regeneration

SN - 1067-1927

IS - 6

ER -