Wound cleansing for pressure ulcers

Zena EH Moore; Seamus Cowman

doi:10.1002/14651858.CD004983.pub2

Limpieza de la herida en las úlceras de decúbito

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Referencias

Referencias de los estudios incluidos en esta revisión

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Referencias de otras versiones publicadas de esta revisión

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estudios excluidos
otras referencias

Moore Z, Cowman S. A systematic review of wound cleansing for pressure ulcers. Journal of Clinical Nursing 2008;17(15):1963‐72.

Characteristics of studies

Characteristics of included studies [ordered by year of study]

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estudios excluidos

Burke 1998

Methods	RCT ‐ single blind. Follow up was for 14 days. Method of allocation unclear.
Participants	In patients with Grade 3 or Grade 4 pressure ulcers (no information on the classification system provided). 18 subjects with 42 ulcers, 18 wounds in non‐whirlpool group and 24 ulcers in whirlpool group.
Interventions	Intervention group: hydrotherapy provided for 20 minutes once a day in a whirlpool bath with water warmed to 96‐98 degrees Fahrenheit. Wounds were irrigated with saline, then dressed with saline‐soaked gauze, dressings changed twice daily. Control group: wounds were irrigated with saline, then dressed with saline‐soaked gauze, dressings changed twice daily.
Outcomes	Improvement in ulcer condition identified by changes in measurement of length and width of the wounds from week to week. Ulcers described as 'improved', 'no change' or 'deteriorated'. Whirlpool group showed superior wound healing (P value = 0.0435), although RevMan analysis did not verify this statistically significant result.
Notes	Information regarding baseline comparability was not reported.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	Quote: "All wounds were identified and randomly assigned to one of the two treatment groups, each ulcer was randomised separately".
Allocation concealment?	Unclear risk	Not stated.
Blinding? Participants ‐ all outcomes	High risk	Not blinded.
Blinding? Blinding of personnel delivering intervention ‐ all outcomes	High risk	Not blinded.
Blinding? Outcome assessors ‐ all outcomes	Low risk	The outcome assessor was blinded. Quotation: "The grading of wounds was completed by a study physician who was blinded as to the study group".
Incomplete outcome data addressed? All outcomes	Low risk	No withdrawals from the study. The same number of wounds randomised were assessed at 2 weeks.
Free of selective reporting?	Low risk
Free of other bias?	Low risk

Griffiths 2001

Methods	RCT, allocation using random numbers table. Follow up for six weeks.
Participants	Patients with chronic wounds of Grade 2 or Grade 3 receiving care in a community setting. 49 wounds, eight of which were pressure ulcers.
Interventions	Intervention group: (n = 6) ulcers cleansed with tap water. Control group: (n = 2) ulcers cleansed with saline. A combination of hydrocolloid and gel or hydrocolloid alone was used topically on the intervention group, whereas either a hydrocolloid alone or a hydrocolloid and hydrocolloid paste was used in the control group.
Outcomes	Sub group analysis not conducted. Three of the six wounds in the tap water group healed, whereas neither of the two wounds in the saline group healed in the study period.
Notes	This study considered more than one type of wound: i.e. lacerations, venous ulcers and pressure ulcers. Information regarding baseline comparability was not reported.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Low risk	Quote: "using a random numbers table".
Allocation concealment?	Unclear risk	Not stated.
Blinding? Participants ‐ all outcomes	Unclear risk	Not stated.
Blinding? Blinding of personnel delivering intervention ‐ all outcomes	Low risk	The nurse performing the dressing was blinded. Quote: "solutions delivered in identical containers to the community nurses"
Blinding? Outcome assessors ‐ all outcomes	Low risk	Quote: "the project manager was blinded and undertook the assessment of the wound at baseline and at 6 weeks".
Incomplete outcome data addressed? All outcomes	High risk	8 participants, 4 from each group were "withdrawn because they stopped participating, were admitted to hospital or did not adhere to the treatment". These participants were not included in the analysis.
Free of selective reporting?	Low risk
Free of other bias?	Low risk

Bellingeri 2004

Methods	Multicentre RCT. Method of allocation unclear. Follow up 14 days.
Participants	Elderly patients of both sexes, with ulcers of > Grade 1 NPUAP scale, dimensions of the ulcer within 10 cm x 10 cm, in patient admission or under home care assistance for greater than 24 hours. Control group: 46 females, 28 males, median age 73 years, range 62 to 83 years. Intervention group: 36 females, 23 males, median age 74 years, range 56 to 84 years.
Interventions	Control group: cleansing with isotonic saline solution. Intervention group: cleansing with Saline spray with Aloe vera, silver chloride and decyl glucoside (Vulnopur). The authors did not describe the precise mechanism of application of the solutions.
Outcomes	Mean percentage reduction in PSST at day 14: Vulnopur ‐22.7 (SD 31.3); isotonic saline ‐11.7 (SD 24.1) (P value =0.025).
Notes	Data analysis conducted on 126 participants, seven participants withdrew from the trial (per protocol analysis carried out because it was not possible to assign a PSST score to those withdrawn from the trial). Information regarding baseline comparability was not reported.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	Not clearly stated.
Allocation concealment?	Unclear risk	Not described.
Blinding? Participants ‐ all outcomes	Unclear risk	Not described.
Blinding? Blinding of personnel delivering intervention ‐ all outcomes	Unclear risk	Not described.
Blinding? Outcome assessors ‐ all outcomes	Unclear risk	Not described.
Incomplete outcome data addressed? All outcomes	Low risk	Seven patients dropped out of the study because they started antibiotic therapy (per protocol analysis carried out).
Free of selective reporting?	Low risk
Free of other bias?	Low risk

Characteristics of excluded studies [ordered by study ID]

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estudios incluidos

Study	Reason for exclusion
Anzai 1989	Study explores wound treatment, not wound cleansing
Bellingeri 2003	Insufficient information (author contacted but no response received).
Boykin 1989	Study explores wound dressings, not wound cleansing.
Colombo 1983	Study explores wound dressings, not wound cleansing.
Della Marchina 1997	Study explores wound dressings, not wound cleansing.
Hartman 2002	Study explores wound dressings, not wound cleansing.
Hinz 1986	Study explores venous leg ulcers, not pressure ulcers.
Kucan 1981	Study explores wound dressings, not wound cleansing.
Liu 1999	Study explores wound dressings, not wound cleansing.
Saydak 1990	Not an RCT, study explores wound dressings, not wound cleansing.
Toba 1997	Study explores wound dressings, not wound cleansing.
Van Der Cammen 1987	Study explores the prevention of pressure ulcers (i.e. no patient had a pressure ulcer at the start of the study).
Wang 1997	Study explores wound treatment, not wound cleansing

Data and analyses

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Comparison 1. Different cleansing solutions

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Saline versus tap water Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
Open in figure viewer Analysis 1.1 Comparison 1 Different cleansing solutions, Outcome 1 Saline versus tap water.
1.1 Healed wound within 6 weeks	1	8	Risk Ratio (M‐H, Fixed, 95% CI)	3.00 [0.21, 41.89]

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Comparison 2. Different cleansing techniques

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Whirlpool versus no whirlpool Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
Open in figure viewer Analysis 2.1 Comparison 2 Different cleansing techniques, Outcome 1 Whirlpool versus no whirlpool.
1.1 Improvement in pressure ulcer	1	42	Risk Ratio (M‐H, Fixed, 95% CI)	2.1 [0.93, 4.76]

Figure 1

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

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Analysis 1.1

Comparison 1 Different cleansing solutions, Outcome 1 Saline versus tap water.

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Analysis 2.1

Comparison 2 Different cleansing techniques, Outcome 1 Whirlpool versus no whirlpool.

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Table 1. Bellingeri 2004 Table of results

Intervention	PSST Baseline	PSST Day 7	PSST Day 14	Total % Change
Isotonic saline solution (control)	mean 31.6 (SD 10.3, min 15.0, max 52.0)	28.9 (SD 10.5, min 12.0, max 52.0).	25.3 (SD 12.2, min 10.0, max 50.0).	‐20.5 (SD 24.1, min ‐65.8, max 22.7).
Saline spray, Aloe vera, silver chloride and decyl glucoside (Vulnopur) (intervention)	mean 31.3 (SD 11.5, min 13.0 max 56.0)	27.1 (SD 11.1, min 13.0, max 54.0).	21.6 (SD 11.6, min 10.0, max 51,0).	‐27.8 (SD 31.3, min ‐69.8, max 123.5).

Table 1. Bellingeri 2004 Table of results

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Comparison 1. Different cleansing solutions

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Saline versus tap water Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.1 Healed wound within 6 weeks	1	8	Risk Ratio (M‐H, Fixed, 95% CI)	3.00 [0.21, 41.89]

Comparison 1. Different cleansing solutions

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Comparison 2. Different cleansing techniques

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Whirlpool versus no whirlpool Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.1 Improvement in pressure ulcer	1	42	Risk Ratio (M‐H, Fixed, 95% CI)	2.1 [0.93, 4.76]

Comparison 2. Different cleansing techniques

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Referencias

Referencias de los estudios incluidos en esta revisión

Bellingeri 2004 {published data only}

Burke 1998 {published data only}

Griffiths 2001 {published data only}

Referencias de los estudios excluidos de esta revisión

Anzai 1989 {published data only}

Bellingeri 2003 {published data only}

Boykin 1989 {published data only}

Colombo 1983 {published data only}

Della Marchina 1997 {published data only}

Hartman 2002 {published data only}

Hinz 1986 {published data only}

Kucan 1981 {published data only}

Liu 1999 {published data only}

Saydak 1990 {published data only}

Toba 1997 {published data only}

Van Der Cammen 1987 {published data only}

Wang 1997 {published data only}

Referencias adicionales

Alarcon 1999

Allman 1997

Angeras 1992

Bates‐Jensen 1992

Beaglehole 1993

Bennett 2004

Bergstrom 1994

BNF 2003

Bo 2003

Bradley 1999

Bradley 1999a

Bridel 1996

Carville 1995

Clark 1992

Clark 1994

Clark 1998

Clark 2002

CLIB Training 2003

Cullum 2001

Cutting 1990

David 1983

Davies 1991

Dealey 1991

EPUAP 2002

EPUAP 2003

Fergusson 2002

Fernandez 2008

Flanagan 1998a

Flanagan 1998b

Fox 2002

Glide 1992

Greenhalgh 1997

Haalboom 2000

Hanson 1993

Hellewell 1997

Higgins 2008

Iocono 1998

Kaltenthaler 2001

Khan 2001

Lawrence 1997

Lefebvre 2008

Lindholm 1999

McInnes 2004

Moher 2001

Moore 2000

Morison 1989

Nixon 1999

NPUAP 1989

O'Dea 1995

O'Meara 2001

Richardson 1981

Robertson 1990

Rolstad 2000

Schoonhoven 2002

SIGN 2009

Singer 1994

Stotts 2001

Szor 1997