New Treatment for Donor Sites

Burn Clinical Trial

— Donors  

Official title:

New Treatment for Donor Sites

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00591916
• Other study ID #: 06-388
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: December 26, 2007
• Last updated: December 10, 2012
• Start date: January 2006
• Est. completion date: November 2010

Study information

• Verified date: December 2012
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Primary research questions/Purpose of the Research.

1. Determine the short term (epidermal regeneration, reduction of pain, infections and length of stay) and long term (scarring, long term recovery, and cost of treatment) outcomes of Microbial Nanocellulose (NC) and fine mesh gauze impregnated with hyaluronan and thrombin (HT).

2. Determine if donor site treatment with NC and HT is as safe as the use of Scarlet Red ointment dressing.

b. Describe the importance of the knowledge that you expect to gain from the research.

To find a donor site dressing that has outcomes equal or better than that of scarlet red.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 90 Years

Eligibility

Inclusion Criteria:

• Ages 0-90 years.

• Any patient admitted to the hospital with burn injury requiring grafting and a donor site.

Exclusion Criteria:

• Patient with severe burn injuries expected to die.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burn

Intervention

Drug:
• Application of donor site dressing [scarlet red, Microbial Nanocellulose (NC), or hyaluronan and thrombin (HT)]
Application of donor site dressing: scarlet red, Microbial Nanocellulose (NC), or hyaluronan and thrombin (HT).

Procedure:
• Blood sample
Obtain blood specimen at surgery donor site harvest, 14 days post surgery and 6 months post surgery
• Biopsy
Tissue biopsy of donor site treated area at admission, wound healing and 2-6 months post burn.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	epidermal regeneration (donor site healing)		Days 3-14 post surgery	No
Secondary	Infection		Days 0-21 post surgery	Yes
Secondary	reduction in pain of donor site		Day 0-21 post surgery	No
Secondary	Scarring		Day 7 post surgery to 2 years post surgery	No
Secondary	Costs		Admission post burn injury to 2 years post burn injury	No