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Evaluation of Skin Tear healing outcomes utilising two differing wound dressing types.

Pilot Study: Adhesive silicone foam dressing versus meshed silicone interface dressing for the management of skin tears: a comparison of healing rates, patients’ and nurses’ satisfaction.

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000294651
Enrollment
52
Registered
2023-03-17
Start date
2013-11-12
Completion date
2020-02-13
Last updated
2023-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Brief summary: The purpose of this pilot study is to assess Skin Tear healing trends with the use of two differing wound dressing types (adhesive silicone foam dressing versus meshed silicone interface dressing), the dressing performance outcomes and the patient and staff satisfaction with the use of these two products. These two products are currently in use for the treatment of Skin Tears within the TPCH based on a standardised treatment regime. This regime is based on best available evidence, which included expert opinion and a regime generated by a dressing product manufacturer. Although the two options are based on a review of the evidence, there is minimal evidence in regards to their skin tear treatment efficacy. In practice, the decision to use one or the other is based on individual staff preference. The hypothesis is that one of the dressings advantages versus disadvantages, in comparison to the alternative will result in improved healing outcomes, patient and staff satisfaction. The design of the study is a randomised study of TPCH patients sustaining upper limb skin tears. A consecutive, convenience sample of 126 adults (aged 18 or over) will be recruited. Following consent patients will be randomised into two treatment arms with their Skin Tears dressed either with the adhesive silicone foam dressing or the meshed silicone interface dressing. Baseline data will be collected when the skin tear is first assessed and dressed, with follow up data will be collected at 7 days, 14 days, and 21 days.

Interventions

This study assessed Skin Tear healing trends with the use of two differing wound dressing products which were used as part of standard practice to ascertain which product provided the best outcomes. These two dressings were Mepilex Border (adhesive silicone foam dressing) and Mepitel (meshed silicone interface dressing). Both products are manufactured by the same company and fall into the generic category of soft silicone dressings and utilise what is called ‘Safetac Soft Silicone Technology’ (

This study assessed Skin Tear healing trends with the use of two differing wound dressing products which were used as part of standard practice to ascertain which product provided the best outcomes. These two dressings were Mepilex Border (adhesive silicone foam dressing) and Mepitel (meshed silicone interface dressing). Both products are manufactured by the same company and fall into the generic category of soft silicone dressings and utilise what is called ‘Safetac Soft Silicone Technology’ (SSST). While they share the same SSST, they are completely different in terms of appearance, application, and usage. Mepilex Border is a self-adhesive waterproof dressing with foamlike like properties that absorb exudate and evaporate excess exudate (wound ooze) through the top of the dressing via moisture vapour permeability. The dressing contact layer (which sits on the skin) contains the SSST. When placed onto a skin tear this layer anchors the skin flap preventing movement. The absorptive pad absorbs the exudate preventing maceration of the flap and periwound area. Mepitel is a wound contact layer not unlike traditional tulle gras (paraffin coated open weave gauze) in appearance; however unlike this traditional dressing, Mepitel is wholly constructed with the SSST. This dressing is placed on a skin tear and the surrounding skin, the SSST anchors the skin flap to the surrounding skin and allows exudate to pass through the dressing. This dressing requires a secondary covering to be placed on top to absorb the exudate, for example a combine pad (cotton wool) and then a bandage to hold the dressing in place. Patients were randomised into two treatment arms with their Skin Tears dressed either with the adhesive silicone foam dressing or the meshed silicone interface dressing. Apart from the two different products used, the total care procedure was the same for both. The Research Nurse/Assistant (RA) collected baseline data when the skin tear was first assessed, with follow-up data collected at 7 days, 14 days, and 21 days. The RA was responsible for undertaking the dressing (which includes removal of the old dressing, wound cleansing and dressing reapplication - in accordance with the Hospital Wound Management Procedure) as per the random allocation at each data collection time. As per the manufactures guidelines and the protocol, both these dressings were to remain in place for the 7 days between the RA visits. A wound management/treatment form with the dressing plan (as per the random allocation) was included within the patient’s ward clinical documents. If the dressing required changing before the RA visit, the ward nursing staff would change the dressing as per the plan and document this on the wound management/treatment form (in accordance with the Hospital Wound Management Procedure). They had an additional step to call and advice the Research Team of this dressing change. Both the recording on the wound management/treatment form and call to the Research Team were used as strategies to assess adherence to the dressing plan.

Sponsors

The Prince Charles Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Skin tears occurring on the arms Skin Tear STAR category 1A, 1B, 2A, 2B, 3 Skin tears equal to or less than 100 cm2 area

Exclusion criteria

Skin Tear that are older than 72 hours Skin tears occurring on other parts of the body Patients unable attend follow-up Patients with uncontrolled bleeding Patients with a clot beneath the skin flap which is unable to be evacuated

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026