NCT03662997

Clinical Study to Compare 3 Multi-Layered Foam Dressings for the Management of Chronic Wounds

Completed NA Results posted Last updated 1 April 2021

What this trial tests

NA trial testing Bordered Five-Layer Foam Dressing in Chronic Wound in 40 participants. Completed in 15 November 2019.

Timeline

19 March 2019

Primary endpoint
1 October 2019

15 November 2019

Quick facts

Lead sponsor	Molnlycke Health Care AB
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	19 March 2019
Primary completion	1 October 2019
Estimated completion	15 November 2019
Sites	5 locations across United States

Drugs / interventions tested

• Bordered Five-Layer Foam Dressing
• Hydropolymer Foam Dressing
• Hydrocellular Multi-Layer Foam Dressing

Conditions studied

• Chronic Wound — all drugs for Chronic Wound →
• Venous Leg Ulcer — all drugs for Venous Leg Ulcer →
• Diabetic Foot Ulcer — all drugs for Diabetic Foot Ulcer →

Sponsor

Molnlycke Health Care AB — full company profile →

Who can join

Adults 18 to 85, any sex, with Chronic Wound or Venous Leg Ulcer. 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.

% of Participants With Equal or Better Rate of Dressing Durability Primary · 4 weeks

Dressing strike-through determined @ Wk1 Day 3\&7, and Wk3 Day 17\&21. Dressing strike-through that occurred Day 3 and/or 7, Day 17 and/or 21 were included in final dataset. Contributing factors to strike-through: Saturation of dressing pad: * Inappropriate dressing type * Inappropriate dressing change freq. (i.e. more frequent changes required) * Change in wound condition (e.g. increase in exudate amt) Dislodgement of dressing: * Suboptimal dressing application (e.g. selection of inappropriate dressing size, failure to clean periwound skin before applying dressing, insufficient fixation)

Weeks 1 & 3 Five-layer equal or better

Group	Value	95% CI
Five-layer vs Hydropolymer	100.0
Five-layer vs Hydrocellular	94.1

Weeks 2 & 4 Five-layer equal or better

Group	Value	95% CI
Five-layer vs Hydropolymer	69.2
Five-layer vs Hydrocellular	73.3

% of Participants With No Strike-through After 7 Days Wear Time at Day 7 and 21 Primary · Weeks 1 and 3

Intact dressing after 7 days wear time, assessed @ Wk1 Day7 \& Wk3 Day21 only. 1st week of dressing wear (Wks 1 \& 3) is critical for start of wound healing. Contributing factors to strike-through: Saturation of dressing pad: * Inappropriate dressing type * Inappropriate dressing change freq. (i.e. more frequent changes required) * Change in wound condition (e.g. increase in exudate amt) Dislodgement of dressing: * Suboptimal dressing application (e.g. selection of inappropriate dressing size, failure to clean periwound skin before applying dressing, insufficient fixation) * Exposure of d

Five-layer

Group	Value	95% CI
Five-layer vs Hydropolymer	43.8
Five-layer vs Hydrocellular	35.3

Comparator

Group	Value	95% CI
Five-layer vs Hydropolymer	12.5
Five-layer vs Hydrocellular	5.6

% of Participants With Equal or Better Outcomes on Local Wound and Skin Pain Before Dressing Removal With Five-layer Secondary · 4 weeks

Pain was measured by subjects' responses to Visual Analogue Scale (VAS) of 0-10 at intervals of 2, 0=no pain, 10=worst pain ever.

Week 1&3 Five-layer equal or better

Group	Value	95% CI
Five-layer vs Hydropolymer	92.3
Five-layer vs Hydrocellular	75.1

Week 2&4 Five-layer equal or better

Group	Value	95% CI
Five-layer vs Hydropolymer	100.0
Five-layer vs Hydrocellular	83.4

% of Participants With Equal or Better Outcomes on Local Wound and Skin Pain at Removal With Five-layer Secondary · 4 weeks

Pain was measured by subjects' responses to Visual Analogue Scale (VAS) of 0-10 at intervals of 2, 0=no pain, 10=worst pain ever.

Week 1&3 Fiver-layer equal or better

Group	Value	95% CI
Five-layer vs Hydropolymer	69.3
Five-layer vs Hydrocellular	87.6

Week 2&4 Five-layer equal or better

Group	Value	95% CI
Five-layer vs Hydropolymer	100.0
Five-layer vs Hydrocellular	58.3

% of Participants With Equal or Better Outcomes on Local Wound and Skin Pain Immediately After Dressing Removal With Five-layer Secondary · 4 weeks

Pain was measured by subjects' responses to Visual Analogue Scale (VAS) of 0-10 at intervals of 2, 0=no pain, 10=worst pain ever.

Week 1&3 Five-layer equal or better

Group	Value	95% CI
Five-layer vs Hydropolymer	77.0
Five-layer vs Hydrocellular	81.3

Week 2&4 Five-layer equal or better

Group	Value	95% CI
Five-layer vs Hydropolymer	90.9
Five-layer vs Hydrocellular	58.4

% of Participants With Equal or Better Outcomes With Five-layer in Evaluation of the Dressings Secondary · 4 weeks

Dressing evaluation was determined via visual observation by study clinicians and categorized by saturation level: Partly saturated, Mostly saturated, and Strike-through.

Week 1&3 Five-layer equal or better

Group	Value	95% CI
Five-layer vs Hydropolymer	100.0
Five-layer vs Hydrocellular	70.6

Week 2&4 Five-layer equal or better

Group	Value	95% CI
Five-layer vs Hydropolymer	84.6
Five-layer vs Hydrocellular	73.3

% of Participants With Equal or Better Outcomes With Five-Layer When Assessing Wound Granulation Secondary · 4 weeks

Wound granulation was measured by visual assessment and photodigital planimetry. Wound granulation were grouped into 6 categories: None, \<25%, 25-49%, 50-74%, 75-99%, 100%.

Week 1&3 Five-layer equal or better

Group	Value	95% CI
Five-layer vs Hydropolymer	92.3
Five-layer vs Hydrocellular	93.8

Week 2&4 Five-layer equal or better

Group	Value	95% CI
Five-layer vs Hydropolymer	81.8
Five-layer vs Hydrocellular	66.7

% of Participants With Equal or Better Outcomes With Five-Layer When Assessing Wounds for Non-viable Tissue (Eschar, Fibrin Slough, Both) Secondary · 4 weeks

Non-viable tissue was determined by visual assessment and photodigital planimetry. Non-viable tissues were grouped into 5 categories: None, \<25%, 25-49%, 50-74%, 75-100%.

Week 1&3 Five-layer equal or better

Group	Value	95% CI
Five-layer vs Hydropolymer	100.0
Five-layer vs Hydrocellular	93.8

Week 2&4 Five-layer equal or better

Group	Value	95% CI
Five-layer vs Hydropolymer	90.9
Five-layer vs Hydrocellular	91.6

Mean Difference in Score in SF12 Health-Related Quality-of-Life Questionnaire Secondary · 4 weeks

The SF-12 health survey consists of 12 questions that yield an eight-scale profile of functional health and well-being, and 2 component summary measures of physical and mental health. SF-12 scores range from 0 to 100 with lower scores indicate lower levels of health. SF-12 questionnaire was administered at Screening/Baseline, Day 14, and Day 28 visits, and scored by a 3rd party vendor. Results are mean differences between five-layer vs the comparator dressing and presented for each of the 8 health domains, and 2 component summary measures. Negative scores indicate lower SF-12 scores (indica

Change in Physical Functioning

Group	Value	95% CI
Five-layer vs Hydropolymer	-0.896	± 9.386
Five-layer vs Hydrocellular	-3.13	± 13.84

Change in Role Physical

Group	Value	95% CI
Five-layer vs Hydropolymer	1.99	± 10.47
Five-layer vs Hydrocellular	0.001	± 11.461

Change in Bodily Pain

Group	Value	95% CI
Five-layer vs Hydropolymer	-6.57	± 9.80
Five-layer vs Hydrocellular	5.11	± 14.31

Change in General Health

Group	Value	95% CI
Five-layer vs Hydropolymer	-0.449	± 5.788
Five-layer vs Hydrocellular	3.47	± 9.89

Change in Physical Component

Group	Value	95% CI
Five-layer vs Hydropolymer	-0.545	± 7.777
Five-layer vs Hydrocellular	1.00	± 10.06

Change in Role Emotional

Group	Value	95% CI
Five-layer vs Hydropolymer	-6.26	± 12.68
Five-layer vs Hydrocellular	-2.61	± 5.35

Change in Social Functioning

Group	Value	95% CI
Five-layer vs Hydropolymer	-7.12	± 15.19
Five-layer vs Hydrocellular	-0.661	± 18.685

Change in Vitality

Group	Value	95% CI
Five-layer vs Hydropolymer	-0.767	± 14.391
Five-layer vs Hydrocellular	2.63	± 12.72

% Participant Compliance in Wear Time Between Five-layer and Comparator Dressing Secondary · 1 week

Compliance with the 7-day wear time protocol, within the first critical week of treatment. Compliance is defined as participants who wore a dressing continuously from time of application until removal at Day 7 visit. This includes participants whose dressing did not have strikethrough up to Day 7 and those who wore their dressing until strikethrough at Day 7 when dressing was removed.

First week compliance rate - Five-layer

Group	Value	95% CI
Five-layer vs Hydropolymer	52.9
Five-layer vs Hydrocellular	62.6

First week compliance rate - Comparator

Group	Value	95% CI
Five-layer vs Hydropolymer	27.8
Five-layer vs Hydrocellular	18.8

Adverse events — posted to ClinicalTrials.gov

Time frame: Two weeks for each intervention.. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Hydropolymer, Then Five-layer

Serious: 0/11 (0%)

Deaths: 1/11

Five-layer, Then Hydropolymer

Serious: 0/9 (0%)

Deaths: 4/9

Hydrocellular, Then Five-layer

Serious: 0/11 (0%)

Deaths: 0/11

Five-layer, Then Hydrocellular

Serious: 0/9 (0%)

Deaths: 1/9

Other adverse events (5 terms — click to expand)

Reaction	System	Hydropolymer, Then Five-la…	Five-layer, Then Hydropoly…	Hydrocellular, Then Five-l…	Five-layer, Then Hydrocell…
Infection to study ulcer	Infections and infestations	—	—	—	—
Blister plantar midfoot	Skin and subcutaneous tissue disorders	—	—	—	—
Pain due to compression	General disorders	—	—	—	—
Increased pain to study limb	General disorders	—	—	—	—
Blister left plantar forefoot	Skin and subcutaneous tissue disorders	—	—	—	—

Data from ClinicalTrials.gov NCT03662997 adverse events section.

Sponsor's own description

A prospective, randomized, controlled clinical trial (RCT) using a cross-over (repeated measures) design to evaluate safety and efficacy of three foam wound dressings in the local management of chronic wounds.

Publications & conference data

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

1. Advancements in Wound Dressing Materials: Highlighting Recent Progress in Hydrogels, Foams, and Antimicrobial Dressings.
   Alberts A, Tudorache DI, Niculescu AG, Grumezescu AM. · · 2025 · cited 28× · PMID 39996666 · DOI 10.3390/gels11020123