Collagenase Ointment Application at 24- versus 48-hour Intervals in the Treatment of Pressure Ulcers: A Randomised Multicentre Study
Authors: Pastor S.1; Burgos A.2; Hernández C.3; Giménez J.2; Ballesteros E.4; Moreno E.2; Rivera C.5; Campos J.6; Ardanaz J.6; Talaero C.6; Sanz M.7; García J.8; Benito S.1
Source: Clinical Drug Investigation, Volume 19, Number 6, June 2000 , pp. 399-407(9)
Publisher: Adis International
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Abstract:
Objective: The purpose of the present study was to demonstrate clinical equivalence between the application of collagenase ointment at 24- and 48-hour intervals in the healing of pressure ulcers.
Design and Setting: This was a multicentre, randomised, nonblind, parallel group study conducted at eight hospitals in Spain.
Patients: A total of 102 hospitalised or institutionalised patients of either gender aged 55 years or over having had stage III pressure ulcers for <1 year were included in the study.
Methods: Reduction of ulcer area by direct and indirect measurements at 1-week intervals was the primary outcome measure. The equivalence margin was established in advance at ±20% of ulcer area. Two one-sided t-test procedures and the confidence intervals of the differences were used to test equivalence.
Results: Both therapeutic regimens significantly reduced the mean ulcer areas throughout the 8-week study. In the first month the two regimens proved to be equivalent. It would have been necessary to include more patients to demonstrate equivalence in the second month of treatment.
Conclusions: Once the healing process is initiated the daily collagenase ointment application can be changed to alternate days.
Keywords: Collagenase, therapeutic use; Decubitus ulcer, treatment; Enzymes, therapeutic use; Wound healing
Language: English
Document Type: Original article
Affiliations: 1: Nursing Unit, Hospital de San Juan de Dios, Córdoba, Spain 2: Medical Department, Laboratorios Knoll, SA, Madrid, Spain 3: Nursing Unit, Residencia Los Nogales, Madrid, Spain 4: Nursing Unit, Hospital Juan Grande, Jerez de la Frontera, Spain 9 Nursing Unit, Hospital San Juan de Dios, Sevilla, Spain 5: 6: Unit of Geriatrics, Hospital de Sant Gervasi, Barcelona, Spain 3 Nursing Unit, Hospital Doctor Moliner, Valencia, Spain 7: Nursing Unit, Hospital de Santa Clotilde, Santander, Spain 8: Unit of Geriatrics, Hospital de San Rafael, Granada, Spain *
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