Macmillan_2007

Supportive Therapie · Version 2.1

Referenz

(Autor, Jahr, Journal)

Studientyp

Mono- vs. Multizentrisch, Verblindung, Randomisierung, Arme, Fallzahl n, Land, Zeitraum

Patienten-merkmale

Indikation, Alter, Geschlecht (m/w)

Intervention

Fallzahl n, Beschreibung der präventiven bzw. therapeutischen Maßnahme

Kontrolle

Fallzahl n, Beschreibung der präventiven Maßnahme bzw. therapeutischen Maßnahme

Zielgrößen

Primärer Endpunkt

Sekundäre(r) Endpunkt(e)

Primärer Endpunkt

Angaben für Intervention vs. Kontrolle

Sekundäre(r) Endpunkt(e)

Angaben für Intervention vs. Kontrolle

Finanzierung

Evidenzstufe

Bei Abwertung: Angabe von Gründen

Bewertung des Autors

Macmillan

2007

Int. J. Radiation Oncology Biol. Phys.

randomized controlled clinical trial

n = 357

2 centre

breast, head-and-neck, or anorectal

cancer

radical RT

Gel dressing

Age (y)

<50: 28 (16)

50–59: 47 (27)

60–69: 63 (36)

≥70: 38 (22)

Gender

Male: 53 (30)

Female: 123 (70)

Dry dressing

Age (y)

<50:) 34 (19)

50–59: 74 (41))

60–69: 40 (22)

≥70: 33 (18)

Gender

Male: 42 (23)

Female: 139 (77)

hydrogel (Intrasite), with Tricotex as a secondary dressing

simple dry

dressings (Tricotex)

primary endpoint:

time to heal the moist desquamation

secondary endpoints: patient diary cards during the days before and after the start of using the dressings

N = 100 (28%) developed moist desquamation

Occurrence (mean):

32 days after the start of treatment (range, 16–50 days).

Gel dressing vs. dry dressing:

Incidence: 58 vs. 42, p = 0.10

time to healing:

HR 0.64; 95% CI: 0.42– 0.99

healing of moist desquamation: patients assigned to gel dressings healed significantly more

slowly (p = 0.03)

87 pts

dry dressing or no dressing: n = 37

gel dressings: n = 50

patient diary items (pain, itch, burning, sleep, and erythema scores)

10 days before and 10 days after the application of the dressings:

desquamation score, which improved significantly more in the dry or no dressing group.

not blinded
enthusiasm for the novel therapy
greater compliance in the group allocated to the gel dressings

"The results of this study have not supported the routine use of hydrogels in the care of patients with moist desquamation and suggests that the healing times are prolonged, without any improvement in patient comfort."