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Double-blinded Prospective Randomised Controlled Trial of Split Skin Graft Donor-Site Dressing: Altrazeal vs. Kaltostat

Double-blinded Prospective Randomised Controlled Trial of Split Skin Graft Donor-Site Dressing: A Clinical Comparative Trial of a Novel Transforming Powder Dressing, Altrazeal (TM) and Calcium Sodium Alginate, Kaltostat (TM) Dressing.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614000473662
Enrollment
60
Registered
2014-05-06
Start date
2014-05-12
Completion date
2014-07-14
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

The purpose of this study is: 1. To determine whether Novel Transforming Powder, Altrazeal (TM) dressing will consistently reduce patient’s experience of pain compared with Calcium Sodium Alginate, Kaltostat (TM). 2. To determine if there is a difference in rate of healing of the donor site between Novel Transforming Powder, Altrazeal (TM) and Calcium Sodium Alginate, Kaltostat (TM). 3. To compare Novel Transforming Powder, Altrazeal (TM) and Calcium Sodium Alginate, Kaltostat (TM) dressings in terms of cost-effectiveness, wound infection rate and cosmetic outcome.

Interventions

Novel Transforming Powder Dressing, Altrazeal (TM), is a dressing type that comes in powder form, which is immediately applied onto the thigh after split skin graft had been harvested. It is then dressed with secondary dressings including gauze and mefix. All dressings are left intact for at least 2 weeks until reviewed in outpatient clinic. It is a once-only dressing which will not require a repeat application unless the initial dressings comes off prematurely as a result of significant haemato

Novel Transforming Powder Dressing, Altrazeal (TM), is a dressing type that comes in powder form, which is immediately applied onto the thigh after split skin graft had been harvested. It is then dressed with secondary dressings including gauze and mefix. All dressings are left intact for at least 2 weeks until reviewed in outpatient clinic. It is a once-only dressing which will not require a repeat application unless the initial dressings comes off prematurely as a result of significant haematoma.

Sponsors

Plastic and Reconstructive Surgery Department, Monash Health
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

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

Inclusion criteria

Participants will be adults (aged 18 years or older) undergoing split skin grafting at Dandenong Hospital. To be included, patients will have a traumatic wound or large skin neoplasms in lower limbs requiring excision leaving a skin defect of at least 10cm2.

Exclusion criteria

1. Patient unable to provide consent due to cognitive impairment (e.g. intellectual disability, dementia, delirium, or unconscious). 2. Patients with known sensitivity or allergies to either Calcium Sodium Alginate, Kaltostat(TM) or Novel Transforming Powder, Altrazeal (TM) dressings or its components. 3. Pregnant women.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026