Who is sponsoring NCT01602458?

NCT01602458 is sponsored by Seton Healthcare Family.

What drugs are being tested in NCT01602458?

Interventions in NCT01602458: Silicone Only Therapy (SOT), Silicone Pressure Garment Therapy (SPGT).

What condition does NCT01602458 study?

NCT01602458 studies Hypertrophic Scarring.

Is NCT01602458 still recruiting?

NCT01602458 is currently completed. Last updated 16 May 2019.

Last reviewed 2019-05-16 · How we verify

NCT01602458

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

The Use of Pressure and Silicone in Children With Skin Grafts After Traumatic Skin Injury: A Randomized Control Trial for Preventative Scar Management

Completed NA Last updated 16 May 2019

What this trial tests

NA trial testing Silicone Only Therapy (SOT) in Hypertrophic Scarring in 12 participants. Completed in 1 November 2013.

Timeline

1 May 2011

Primary endpoint
1 November 2013

1 November 2013

Quick facts

Lead sponsor	Seton Healthcare Family
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	1 May 2011
Primary completion	1 November 2013
Estimated completion	1 November 2013
Sites	1 location across United States

Drugs / interventions tested

Silicone Only Therapy (SOT)
Silicone Pressure Garment Therapy (SPGT)

Conditions studied

Hypertrophic Scarring — all drugs for Hypertrophic Scarring →

Sponsor

Seton Healthcare Family — full company profile →

Who can join

Adults 1 to 18, any sex, with Hypertrophic Scarring. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Patient Observer Scar Assessment Scale (POSAS)
Time frame: Baseline, 8 weeks, 16 weeks, and 24 weeks
This scale incorporates the patient's/caregiver's perspective on their scar. It measures scar color, pliability, thickness, relief, itching, and pain scored by patient/caregiver. The observer scale measures vascularization, pigmentation, pliability, thickness, and relief.
Vancouver Scar Scale (VSS)
Time frame: Baseline, 8 weeks, 16 weeks, and 24 weeks
This scale scores pigmentation, vascularity, pliability, and scar height with the sum of the scores that correlates with hypertrophic scars.

Sponsor's own description

The study's objective is to compare the global scar outcomes in those treated with silicone only therapy (SOT) versus silicone pressure garment therapy (SPGT) for the prevention of hypertrophic scarring in children with skin grafts after traumatic skin injury.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Pressure-garment therapy for preventing hypertrophic scarring after burn injury.
Harris IM, Lee KC, Deeks JJ, Moore DJ, et al · · 2024 · cited 8× · PMID 38189494 · DOI 10.1002/14651858.cd013530.pub2
The Molecular Mechanisms Involved in the Hypertrophic Scars Post-Burn Injury.
Pradhan M, Pethe P. · · 2023 · cited 5× · PMID 38161582 · DOI 10.59249/rhuf5686

Verify or expand the search:

Other recruiting trials for Hypertrophic Scarring

Currently open trials in the same condition.

NCT07213544 — Remimazolam vs Propofol in Laser Burn Cases · Phase 4 · recruiting
NCT06104540 — Comparison of the Effects of Liquid Vaseline and Olive Oil on Itching and Scarring in Scald Burns · NA · recruiting

Other Seton Healthcare Family trials

Trials by the same sponsor.

NCT03223701 — Efficacy of Using Solum IV and BMC With GFC in TLIF · Phase 4 · withdrawn
NCT03077204 — BIO4 Clinical Case Study: Cervical Spine · Phase 4 · completed
NCT02242578 — Treating Refractory Schizophrenia With rTMS · NA · terminated

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 NCT01602458 (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 Seton Healthcare Family
Last refreshed: 16 May 2019

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/NCT01602458.

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