NCT00787592

Brief Summary

The objective of this study is to evaluate the outcomes of children with burn injury with regard to the utilization of Silver sulfadiazine (SSD) cream and Collagenase ointment. The primary outcome variable will be need for skin grafting. The specific aim of the study is to prospectively collect data to determine if SSD is superior to Collagenase with regard to avoiding the need for skin grafting.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 7, 2008

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

January 8, 2021

Status Verified

January 1, 2021

Enrollment Period

4 years

First QC Date

November 6, 2008

Last Update Submit

January 7, 2021

Conditions

Keywords

Burnschildrencollagenasesilver sulfadiazineChildhood burns

Outcome Measures

Primary Outcomes (1)

  • Need for skin grafting

    10 days

Secondary Outcomes (1)

  • Development of burn contractures

    1 year

Study Arms (2)

Silver Sulfadiazide (SSD)

Patients that receive SSD as the topical debriding agent

Collagenase

Patients that receive collagenase as the debriding agent

Eligibility Criteria

Age2 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children between the ages of 2 months and 18 years of age that have at least second degree burns that involve less than 25% of their total body surface area.

You may qualify if:

  • Partial thickness burn
  • Less than 25% total body surface area burn
  • Less than 18 years of age
  • Greater than 2 months of age

You may not qualify if:

  • Greater than 25% total body surface burn
  • years of age or older
  • Younger than 2 months of age
  • Allergy to sulfa

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Mercy Hospital and Clinics

Kansas City, Missouri, 64108, United States

Location

Related Publications (3)

  • Hansbrough JF, Achauer B, Dawson J, Himel H, Luterman A, Slater H, Levenson S, Salzberg CA, Hansbrough WB, Dore C. Wound healing in partial-thickness burn wounds treated with collagenase ointment versus silver sulfadiazine cream. J Burn Care Rehabil. 1995 May-Jun;16(3 Pt 1):241-7. doi: 10.1097/00004630-199505000-00004.

    PMID: 7673302BACKGROUND
  • Ozcan C, Ergun O, Celik A, Corduk N, Ozok G. Enzymatic debridement of burn wound with collagenase in children with partial-thickness burns. Burns. 2002 Dec;28(8):791-4. doi: 10.1016/s0305-4179(02)00191-2.

    PMID: 12464480BACKGROUND
  • Atiyeh BS, Costagliola M, Hayek SN, Dibo SA. Effect of silver on burn wound infection control and healing: review of the literature. Burns. 2007 Mar;33(2):139-48. doi: 10.1016/j.burns.2006.06.010. Epub 2006 Nov 29.

    PMID: 17137719BACKGROUND

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Daniel J Ostlie, MD

    Children's Mercy Hospital and Clinics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2008

First Posted

November 7, 2008

Study Start

January 1, 2008

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

January 8, 2021

Record last verified: 2021-01

Locations