NCT03877484 is a clinical trial of ALLEVYN Gentle border in Wound, sponsored by Smith & Nephew Orthopaedics AG.

Who is sponsoring NCT03877484?

NCT03877484 is sponsored by Smith & Nephew Orthopaedics AG.

What drugs are being tested in NCT03877484?

Interventions in NCT03877484: ALLEVYN Gentle border.

Is NCT03877484 still recruiting?

NCT03877484 is currently completed. Last updated 9 December 2024.

Are results published for NCT03877484?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-12-09 · How we verify

NCT03877484

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Evaluation of the Safety and Effectiveness of ALLEVYN Gentle Border

Completed Results posted Last updated 9 December 2024

What this trial tests

trial testing ALLEVYN Gentle border in Wound in 43 participants. Completed in 19 November 2021.

Timeline

6 March 2019

Primary endpoint
19 November 2021

19 November 2021

Quick facts

Lead sponsor	Smith & Nephew Orthopaedics AG
Status	Completed
Study type	OBSERVATIONAL
Enrollment	43
Start date	6 March 2019
Primary completion	19 November 2021
Estimated completion	19 November 2021
Sites	6 locations across France, United Kingdom, Germany

Drugs / interventions tested

ALLEVYN Gentle border

Conditions studied

Wound — all drugs for Wound →

Sponsor

Smith & Nephew Orthopaedics AG

Who can join

18 and older, any sex, with 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.

Change in Wound Area From Baseline to End of Study Visit Primary · Baseline through 28 days (±3 days).

Change in wound area from baseline to end of study visit at 28 days was measured by wound photographs from a specific digital camera that standardized and calculated wound length, width, and depth automatically.

Group	Value	95% CI
ALLEVYN Gentle Border	2.2	0.9 – 3.9

Change in Wound Area From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), and 21 Days (±3 Days) Secondary · Baseline to 7 days (±3 days), 14 days (±3 days), and 21 days (±3 days)

Change in wound area from baseline to 7 days, 14 days and 21 days. Wound area was measured by photographs from a specific digital camera that standardized and calculated wound length, width, and depth automatically.

Baseline to 7 days (±3 days)

Group	Value	95% CI
ALLEVYN Gentle Border	0.5	-0.2 – 0.8

Baseline to 14 days (±3 days)

Group	Value	95% CI
ALLEVYN Gentle Border	1.2	0.5 – 2.1

Baseline to 21 days (±3 days)

Group	Value	95% CI
ALLEVYN Gentle Border	1.7	0.6 – 3.1

Change in Wound Depth From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days) Secondary · Baseline, 7 days, 14 days, 21 days, 28 days

Wound depth at baseline, 7, 14, 21 and 28 days were measured by wound photographs from a specific digital camera that standardized and calculated wound length, width, and depth automatically.

Baseline to 7 Days

Group	Value	95% CI
ALLEVYN Gentle Border	0.1	0.01 – 0.3

Baseline to 14 Days

Group	Value	95% CI
ALLEVYN Gentle Border	0.1	-0.01 – 0.3

Baseline to 21 Days

Group	Value	95% CI
ALLEVYN Gentle Border	0.1	-0.01 – 0.6

Baseline to 28 Days

Group	Value	95% CI
ALLEVYN Gentle Border	0.1	-0.01 – 0.6

Change in Wound Volume From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days) Secondary · Baseline, 7 days, 14 days, 21 days, and 28 days

Change in exudate wound volume measured from baseline to 7 days, 14 days, 21 days and 28 days.

Baseline to 7 Days (±3 Days)

Group	Value	95% CI
ALLEVYN Gentle Border	0.07	-0.01 – 0.2

Baseline to 14 Days (±3 Days)

Group	Value	95% CI
ALLEVYN Gentle Border	0.08	-0.01 – 0.2

Baseline to 21 Days (±3 Days)

Group	Value	95% CI
ALLEVYN Gentle Border	0.1	0.01 – 0.3

Baseline to 28 Days (±3 Days)

Group	Value	95% CI
ALLEVYN Gentle Border	0.1	0.02 – 0.3

Percentage Change in Wound Area From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), and 21 Days (±3 Days) Secondary · Baseline to 7 days (±3 days), 14 days (±3 days), and 21 days (±3 days)

Percentage change in wound area from baseline visit to visits 2 (7 Days), 3 (14 days) and 4 (21 days).

Baseline to 7 days (±3 days)

Group	Value	95% CI
ALLEVYN Gentle Border	9.5	-37.9 – 91.8

Baseline to 14 days (±3 days)

Group	Value	95% CI
ALLEVYN Gentle Border	21.3	-118.8 – 100

Baseline to 21 days (±3 days)

Group	Value	95% CI
ALLEVYN Gentle Border	40.8	-152.8 – 100

Baseline to 28 Days

Group	Value	95% CI
ALLEVYN Gentle Border	49.9	-114 – 100

Percentage Change in Wound Depth From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), and 21 Days (±3 Days) Secondary · Baseline to 7 days (±3 days), 14 days (±3 days), and 21 days (±3 days)

Percentage change in wound depth from baseline visit to visits 2 (7 Days), 3 (14 days) and 4 (21 days).

Baseline to 7 days (±3 days)

Group	Value	95% CI
ALLEVYN Gentle Border	29.1	-4402.2 – 94.6

Baseline to 14 days (±3 days)

Group	Value	95% CI
ALLEVYN Gentle Border	34.7	-1306 – 100

Baseline to 21 days (±3 days)

Group	Value	95% CI
ALLEVYN Gentle Border	40	-3795.5 – 100

Baseline to 28 Days (±3 days)

Group	Value	95% CI
ALLEVYN Gentle Border	27.7	-1433.9 – 100

Percentage Change in Wound Volume From Baseline to 7 Days (±3 Days), 14 Days (±3 Days), and 21 Days (±3 Days) Secondary · Baseline to 7 days (±3 days), 14 days (±3 days), and 21 days (±3 days)

Percentage change in wound volume from baseline visit to visits 2 (7 Days), 3 (14 days) and 4 (21 days).

Baseline to 7 days (±3 days)

Group	Value	95% CI
ALLEVYN Gentle Border	38.7	-5023.5 – 97.6

Baseline to 14 days (±3 days)

Group	Value	95% CI
ALLEVYN Gentle Border	21.3	-118.8 – 100

Baseline to 21 days (±3 days)

Group	Value	95% CI
ALLEVYN Gentle Border	40.8	-152.8 – 100

Baseline to 28 Days (±3 days)

Group	Value	95% CI
ALLEVYN Gentle Border	49.9	-114 – 100

Exudate Management: Number of Dressings With Leakage Secondary · Dressing application to removal, up to 7 days (±3 Days)

The count of dressings applied on participants with exudate present that experienced any dressing leakage (Yes/No).

Group	Value	95% CI
ALLEVYN Gentle Border	34
ALLEVYN Gentle Border	208

Exudate Amount at 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days) Secondary · 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), and 28 days (±3 Days)

Count of participants with wound exudate amounts identified as: * None * Scant * Small * Moderate * Large

7 days (±3 Days)

Group	Value	95% CI
ALLEVYN Gentle Border	5
ALLEVYN Gentle Border	4
ALLEVYN Gentle Border	13
ALLEVYN Gentle Border	16

14 days (±3 Days)

Group	Value	95% CI
ALLEVYN Gentle Border	7
ALLEVYN Gentle Border	2
ALLEVYN Gentle Border	19
ALLEVYN Gentle Border	11

21 days (±3 Days)

Group	Value	95% CI
ALLEVYN Gentle Border	7
ALLEVYN Gentle Border	2
ALLEVYN Gentle Border	20
ALLEVYN Gentle Border	9

28 days (±3 Days)

Group	Value	95% CI
ALLEVYN Gentle Border	8
ALLEVYN Gentle Border	3
ALLEVYN Gentle Border	17
ALLEVYN Gentle Border	8

Exudate Type at 7 (±3 Days), 14 (±3 Days), 21 (±3 Days) and 28 Days (±3 Days) Secondary · 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), and 28 days (±3 Days)

Count of participants with wound exudate types identified as: * None * Bloody * Serosanguineous * Serous * Purulent

7 days (±3 Days)

Group	Value	95% CI
ALLEVYN Gentle Border	5
ALLEVYN Gentle Border	1
ALLEVYN Gentle Border	20
ALLEVYN Gentle Border	11

14 days (±3 Days)

Group	Value	95% CI
ALLEVYN Gentle Border	7
ALLEVYN Gentle Border	1
ALLEVYN Gentle Border	19
ALLEVYN Gentle Border	7

21 days (±3 Days)

Group	Value	95% CI
ALLEVYN Gentle Border	7
ALLEVYN Gentle Border	1
ALLEVYN Gentle Border	21
ALLEVYN Gentle Border	7

28 days (±3 Days)

Group	Value	95% CI
ALLEVYN Gentle Border	8
ALLEVYN Gentle Border	0
ALLEVYN Gentle Border	19
ALLEVYN Gentle Border	9

Level of Wound Odour at Baseline, 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days) and 28 Days (±3 Days) Secondary · Baseline, 7 days (±3 Days), 14 days (±3 Days), 21 days (±3 Days), 28 days (±3 Days)

Count of participants level of odour at baseline, 7 Days (±3 Days), 14 Days (±3 Days), 21 Days (±3 Days), and 28 Days (±3 Days) identified as: * None * Mild * Moderate * Strong

Baseline

Group	Value	95% CI
ALLEVYN Gentle Border	34
ALLEVYN Gentle Border	5
ALLEVYN Gentle Border	0
ALLEVYN Gentle Border	1

7 days (±3 Days)

Group	Value	95% CI
ALLEVYN Gentle Border	34
ALLEVYN Gentle Border	6
ALLEVYN Gentle Border	0
ALLEVYN Gentle Border	0

14 days (±3 Days)

Group	Value	95% CI
ALLEVYN Gentle Border	30
ALLEVYN Gentle Border	6
ALLEVYN Gentle Border	0
ALLEVYN Gentle Border	0

21 days (±3 Days)

Group	Value	95% CI
ALLEVYN Gentle Border	26
ALLEVYN Gentle Border	6
ALLEVYN Gentle Border	0
ALLEVYN Gentle Border	0

28 days (±3 Days)

Group	Value	95% CI
ALLEVYN Gentle Border	26
ALLEVYN Gentle Border	4
ALLEVYN Gentle Border	0
ALLEVYN Gentle Border	0

Reason for Dressing Change Secondary · Upon dressing removal, up to 7 days (±3 Days)

Overall frequency of dressing changes categorized with the following reasons(Yes/No): * Reason for dressing change routine * ALLEVYN been in place 7 days * Dressing saturated * Strikethrough * Leakage * Pain * Dressing fell off * Dressing got wet during shower/bathing * Subject removed dressing * Other

Reason for dressing change routine

Group	Value	95% CI
ALLEVYN Gentle Border	34
ALLEVYN Gentle Border	72

ALLEVYN been in place 7 days

Group	Value	95% CI
ALLEVYN Gentle Border	195
ALLEVYN Gentle Border	27

Dressing saturated

Group	Value	95% CI
ALLEVYN Gentle Border	195
ALLEVYN Gentle Border	27

Strikethrough

Group	Value	95% CI
ALLEVYN Gentle Border	197
ALLEVYN Gentle Border	25

Leakage

Group	Value	95% CI
ALLEVYN Gentle Border	212
ALLEVYN Gentle Border	10

Pain

Group	Value	95% CI
ALLEVYN Gentle Border	221
ALLEVYN Gentle Border	1

Dressing fell off

Group	Value	95% CI
ALLEVYN Gentle Border	215
ALLEVYN Gentle Border	7

Dressing got wet during shower/bathing

Group	Value	95% CI
ALLEVYN Gentle Border	220
ALLEVYN Gentle Border	2

Adverse events — posted to ClinicalTrials.gov

Time frame: Following dressing application to study completion, up to 28 days.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

ALLEVYN Gentle Border

Serious: 4/40 (10%)

Deaths: 0/40

Serious adverse events (4 terms)

Reaction	System	ALLEVYN Gentle Border
Wound complication	Injury, poisoning and procedural complications	—
Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	—
Urinary tract infection	Infections and infestations	—
Deep vein thrombosis	Vascular disorders	—

Other adverse events (9 terms — click to expand)

Reaction	System	ALLEVYN Gentle Border
Wound infection	Infections and infestations	—
Periarthritis	Musculoskeletal and connective tissue disorders	—
Infection	Infections and infestations	—
Dermatitis	Skin and subcutaneous tissue disorders	—
Wound complication	Injury, poisoning and procedural complications	—
Skin maceration	Skin and subcutaneous tissue disorders	—
Medical device site erosion	General disorders	—
Urinary retention	Renal and urinary disorders	—
Cellulitis	Infections and infestations	—

Most-reported serious reactions: Wound complication, Pulmonary Oedema, Urinary tract infection, Deep vein thrombosis.

Data from ClinicalTrials.gov NCT03877484 adverse events section.

Sponsor's own description

The clinical study will evaluate the safety and effectiveness of the ALLEVYN Gentle Border. The study is a post-market clinical follow-up to assess clinical performance and safety of ALLEVYN Gentle Border with new wound contact layer to support performance claims.

Publications & conference data

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

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

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03877484 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Smith & Nephew Orthopaedics AG
Last refreshed: 9 December 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03877484.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT03877484

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (4 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Wound

Other Smith & Nephew Orthopaedics AG trials

Verify against primary sources