NCT03468816

Wound Dressing With Moisture Sensor

Completed NA Results posted Last updated 2 June 2020

What this trial tests

NA trial testing Sensor activation (on DryMax Extra Soft) in Ulcer, Leg in 5 participants. Completed in 22 November 2019.

Timeline

28 May 2018

Primary endpoint
22 November 2019

22 November 2019

Quick facts

Lead sponsor	Vårdcentralen Åby
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	5
Start date	28 May 2018
Primary completion	22 November 2019
Estimated completion	22 November 2019
Sites	2 locations across Sweden

Drugs / interventions tested

• Sensor activation (on DryMax Extra Soft)

Conditions studied

• Ulcer, Leg — all drugs for Ulcer, Leg →
• Heal Wound — all drugs for Heal Wound →

Sponsor

Vårdcentralen Åby

Who can join

18 and older, any sex, with Ulcer, Leg or Heal Wound. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Dressing Changes With Sensor Activation at Correct Timing Primary · Inclusion visit to study completed after 3 dressing changes, 1-2 weeks

Sensor activation - measured as indication on the sensor display; indication at correct time, indication but not att correct time, no indication.

Indication at correct timing

Group	Value	95% CI
Variant A	0
Variant B	0

Indication, but not at correct timing

Group	Value	95% CI
Variant A	4
Variant B	2

No indication

Group	Value	95% CI
Variant A	3
Variant B	6

Timing of Dressing Change Related to Dressing Size and Weight After Use Primary · Inclusion visit to study completed after 3 dressing changes, 1-2 weeks

Dressing weight after use were measured on a scale and recorded. The weight were compared to a predefined table. Dressing size 10x10 cm: Changed too early \<11 g Correct change 11-26 g Changed too late \>26 g Dressing size 10x20 cm: Changed too early \<17 g Correct change 17-62 g Changed too late \>62 g Dressing size 20x20 cm: Changed too early \<26 g Correct change 26-109 g Changed too late \>109 g

Size 10x10 cm, weight <11 g

Group	Value	95% CI
Variant A	0
Variant B	0

Size 10x10 cm, weight 11 g - 26 g

Group	Value	95% CI
Variant A	0
Variant B	0

Size 10x10 cm, weight >26 g

Group	Value	95% CI
Variant A	0
Variant B	0

Size 10x20 cm, weight <17 g

Group	Value	95% CI
Variant A	0
Variant B	0

Size 10x20 cm, weight 17 g - 62g

Group	Value	95% CI
Variant A	3
Variant B	6

Size 10x20 cm, weight >72 g

Group	Value	95% CI
Variant A	0
Variant B	0

Size 20x20 cm, weight <26 g

Group	Value	95% CI
Variant A	0
Variant B	0

Size 20x20 cm, weight 26 g - 109 g

Group	Value	95% CI
Variant A	3
Variant B	0

Complications if the Dressing Was Switched Too Late. Secondary · Inclusion visit to study completed after 3 dressing changes, 1-2 weeks

Report of leakage, strike-through and maceration at the time for dressing changes

Group	Value	95% CI
Variant A	3
Variant B	2
Variant A	4
Variant B	6
Variant A	0
Variant B	0

Level of Usability Secondary · Inclusion visit to study completed after 3 dressing changes, 1-2 weeks

Study the rate of handling errors

Group	Value	95% CI
Variant A	7
Variant B	8
Variant A	0
Variant B	0

Wound Size After Three Dressing Changes Secondary · At final dressing change no.3 (after 1-2 weeks)

Wound size after three dressing changes with the study device, measured as cm2. Can be compared with the baseline measurement of wound size.

Group	Value	95% CI
A-B-A	127	± 29
B-A-B	44	± 16

Adverse events — posted to ClinicalTrials.gov

Time frame: Inclusion visit to study completed after 3 dressing changes, 1-2 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Variant A

Serious: 0/5 (0%)

Deaths: 0/5

Variant B

Serious: 0/5 (0%)

Deaths: 0/5

Other adverse events (6 terms — click to expand)

Reaction	System	Variant A	Variant B
Mechanical imprint	Skin and subcutaneous tissue disorders	—	—
Adherence	Skin and subcutaneous tissue disorders	—	—
Pain	Skin and subcutaneous tissue disorders	—	—
High INR value	Blood and lymphatic system disorders	—	—
Infection	Infections and infestations	—	—
Inflamed surrounding skin	Skin and subcutaneous tissue disorders	—	—

Data from ClinicalTrials.gov NCT03468816 adverse events section.

Sponsor's own description

Explorative study of function of a moisture sensor on top of a superabsorbent wound dressing on exuding leg ulcers.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Dressings and topical agents for arterial leg ulcers.
   Broderick C, Pagnamenta F, Forster R. · · 2020 · cited 12× · PMID 31978262 · DOI 10.1002/14651858.cd001836.pub4