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WithdrawnNCT00675974JobstUpdated Nov 15, 2012

Use of Pressure Garments for Burn Scars

A Phase 2/3 interventional study of Jobst Pressure Garment and Medical Z pressure garment in Burns, sponsored by The University of Texas Medical Branch, Galveston. Withdrawn. Open to participants aged 1 Year to 17 Years. Per ClinicalTrials.gov, last updated 2012-11-15.

Sponsored by The University of Texas Medical Branch, Galveston · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
1 Year to 17 Years
Sex
All
01

Study summary

  1. Will Pressure Garment Therapy better control hypertrophic scarring than no Pressure Garment Therapy.
  2. How will Pressure Garment Therapy affect functional capacity or scar contracture development across joints either in number or severity.
  3. Will Pressure Garment Therapy diminish discomfort due to pruritus.
02

Conditions studied

  • Burns

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Keywords

  • Burn
  • Scar
  • Pressure garments
  • Wound healing
  • Burn Injury
03

In context

Burns

719 studies on the registry are indexed under Burns; 145 are open to participants now.

Browse Burns studies →

Lead sponsor

The University of Texas Medical Branch, Galveston is the lead sponsor of 251 studies on the registry; 38 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 25 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • At least 30% total body surface area(TBSA) second degree burns or at least 10% TBSA full-thickness burns including bilateral comparable burns to upper and/or lower extremities.
  • at least 1 year of age and no more than 17 years of age
  • Wound closure
  • No evidence of deep venous thrombosis or other vascular compromise.
  • No concomitant conflicting study protocols.

Exclusion criteria

Exclusion Criteria:

  • Burn injuries not bilateral to upper and/or lower extremities.
  • Evidence of vascular compromise.
  • Conflicting protocols.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    1

    Pressure garment therapy

    Device: Jobst Pressure Garment · Device: Medical Z pressure garment

  • No intervention
    2

    No pressure garment therapy

Interventions

  • DeviceJobst Pressure Garment

    Pressure garment therapy for 18 months post burn injury. May be Jobst pressure garment or Medical Z pressure garment.

    Also known as: Jobst pressure garments, Medical Z pressure garments, Pressure garments

  • DeviceMedical Z pressure garment

    Pressure garment to be worn for 18 months post burn. May be Jobst pressure garment or Medical Z pressure garment.

    Also known as: Pressure garment, Jobst pressure garment

06

What researchers measure

Primary outcomes

  1. Differences in scarring between pressure garment therapy and no pressure garment therapy

    Time frame: Time of burn to 2 years post burn

Secondary outcomes

  1. Effect of Pressure Garment Therapy on functional capacity or scar contracture development across joints either in number or severity compared to no pressure garment therapy.

    Time frame: Time of burn to 2 years post burn

  2. Effect of pressure garment therapy on scar discomfort and pruritis compared to no pressure garment therapy

    Time frame: Time of burn to 2 years post burn

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 15, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00675974
Lead sponsor
The University of Texas Medical Branch, Galveston
Collaborators
U.S. Department of Education
Responsible party
Sponsor
First posted
May 12, 2008
Start date
Aug 2005
Primary completion
Dec 2012 (estimated)
Completion
Dec 2014 (estimated)
Last update
Nov 15, 2012

Study contacts

David N Herndon, MD
principal investigator · University of Texas

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.

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