Washcloths Effectiveness in Preventing Pressure Ulcers

NCT03445975 | Completed DMC

• 1 other identifier: 84/INT/2016
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

A monocentric cluster-crossover design has been used in this study to test the effectiveness of a 3-in-1 perineal care washcloth versus standard of care (e.g., water and pH neutral soap) to prevent and treat pressure ulcers in ICUs.

Conditions

Pressure Ulcer; Skin Ulcer

Outcome Measures

Primary Outcomes (1)

• Pressure Ulcer

  To describe the impact of 3-in-1 washcloths on pressure ulcers. Pressure ulcers are assessed using the classification proposed by the US-National Pressure Ulcer Advisory Panel (NPUAP)

  6 months

Study Arms (2)

Experimental

EXPERIMENTAL

The 3-in-1 perineal care washcloth procedure has been adopted to deliver hygiene care (total or perineal) or baths

Procedure: 3-in-1 perineal care washcloths

standard

NO INTERVENTION

The deliver of hygiene care (total or perineal) or baths has been performed using water and pH neutral soap

Interventions

3-in-1 perineal care washcloths PROCEDURE

The 3-in-1 washcloth was used for daily routine perineal skin hygiene and after each diaper/underpad change. This procedure was intended for cleansing, moisturizing, and application of a barrier protection (dimeticone 3%). 3-in1 washcloths pH range is 3.5 to 5.0.

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients (real-world)

You may not qualify if:

• Under 18 yo
• Patients who present allergic reactions or sensitivity to the experimental procedure

Sponsors & Collaborators

• Ospedale San Donato: lead

Study Sites (1)

IRCCS Policlinico San Donato

San Donato Milanese, MI - Milano, 20097, Italy

Location

Related Publications (4)

• Beeckman D, Verhaeghe S, Defloor T, Schoonhoven L, Vanderwee K. A 3-in-1 perineal care washcloth impregnated with dimethicone 3% versus water and pH neutral soap to prevent and treat incontinence-associated dermatitis: a randomized, controlled clinical trial. J Wound Ostomy Continence Nurs. 2011 Nov-Dec;38(6):627-34. doi: 10.1097/WON.0b013e31822efe52.

  PMID: 21952346 BACKGROUND

• Bliss DZ, Zehrer C, Savik K, Smith G, Hedblom E. An economic evaluation of four skin damage prevention regimens in nursing home residents with incontinence: economics of skin damage prevention. J Wound Ostomy Continence Nurs. 2007 Mar-Apr;34(2):143-52; discussion 152. doi: 10.1097/01.WON.0000264825.03485.40.

  PMID: 17413828 BACKGROUND

• Truong B, Grigson E, Patel M, Liu X. Pressure Ulcer Prevention in the Hospital Setting Using Silicone Foam Dressings. Cureus. 2016 Aug 8;8(8):e730. doi: 10.7759/cureus.730.

  PMID: 27630803 BACKGROUND

• Harris PN, Le BD, Tambyah P, Hsu LY, Pada S, Archuleta S, Salmon S, Mukhopadhyay A, Dillon J, Ware R, Fisher DA. Antiseptic Body Washes for Reducing the Transmission of Methicillin-Resistant Staphylococcus aureus: A Cluster Crossover Study. Open Forum Infect Dis. 2015 May 22;2(2):ofv051. doi: 10.1093/ofid/ofv051. eCollection 2015 Apr.

  PMID: 26125031 BACKGROUND

MeSH Terms

Conditions

Pressure Ulcer; Skin Ulcer

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Health Professions Research and Development Unit

Model Details: This study had a cluster-crossover design, where each of the two involved ICUs was the cluster. The genaral aim was to test the effectiveness of a 3-in-1 perineal care washcloth versus standard of care (e.g., water and pH neutral soap) to prevent and treat pressure ulcers in ICUs. The study has been articulated in two phases, lasted three months each. In the first phase, from the 1st of February to the 2nd of May, the 3-in-1 perineal care washcloth procedure has been adopted by the ICU of San Donato Hospital (Milan, Italy), while the Cardiovascular Intensive Care Unit (CVICU) continued to adopt the standard procedure (water and pH neutral soap). In the second phase, from the 2nd of May to 31st of July, the two procedures have been switched between the two wards.

Study Record Dates

• First Submitted: February 15, 2018
• First Posted: February 26, 2018
• Study Start: February 1, 2017
• Primary Completion: July 31, 2017
• Study Completion: July 31, 2017
• Last Updated: February 26, 2018

Record last verified: 2018-02

Locations

IT (1)