Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03027596
Other study ID # 639/2016
Secondary ID
Status Recruiting
Phase N/A
First received January 18, 2017
Last updated January 19, 2017
Start date January 2017
Est. completion date July 2019

Study information

Verified date January 2017
Source BG Trauma Center Tuebingen
Contact Jens Rothenberger, M.D.
Phone +4970716063898
Email jens.rothenberger@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Burned skin areas, which were initially vital, can be irreversibly damaged by wound progression. The aim of the present study is to evaluate the feasibility of ischemic conditioning to reduce secondary wound progression.


Recruitment information / eligibility

Status Recruiting
Enrollment 140
Est. completion date July 2019
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Ability to understand the study information and the consent to sign

- Thermal injury (burn / scalding) with a clinical evaluated depth of at least 2a (superficial partial)

- At least one of the following sites must not have skin lesions

: Upper arm right and left

- hospital admission within 6 hours after trauma has taken place

Exclusion Criteria:

- Participation in another experimental study

- Pregnancy (women are subjected to a pregnancy test (urine)

- Contraindication for the use of the tourniquet, for example Lymph drainage disorders after axillary lymphadenectomy or Irradiation of the axilla

- Non-compliant patients who are, e.g. Intubated

- Pure 3rd degree burns (full thickness) or charring

- Thermal injuries older than 6 hours

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Remote ischemic conditioning


Locations

Country Name City State
Germany BG Trauma Center, University Tübingen, Germany Tuebingen

Sponsors (1)

Lead Sponsor Collaborator
BG Trauma Center Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change of burn depth Clinical assessment of burn depth day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180
Secondary Change in skin's relative amount of hemoglobin relative amount of hemoglobin (Arbitrary Units) day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180
Secondary Change in skin's blood flow blood flow (Arbitrary Units) day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180
Secondary Change in skin's oxygen saturation oxygen saturation (%) day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180
Secondary Change in skin elasticity objective measurement of the skin elasticity day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180, 360
Secondary Differences in scare development between the study groups Assessment with the Vancouver scare scale day 90, 180, 360
See also
  Status Clinical Trial Phase
Completed NCT05023135 - DeepView SnapShot Portable (DV-SSP): Device Training Study
Completed NCT05276869 - Reliability and Feasibility of WeeFIM Instrument to Measure Functional Independence in Pediatric Burns
Completed NCT04548635 - VR for Burn Dressing Changes at Home Phase 2/Phase 3
Not yet recruiting NCT06076031 - Effects of Applying Streaming Media on Reducing Pain in Patient With Second-degree Burn During Changing Dressing N/A
Recruiting NCT05084248 - Vitamin D Deficiency in Adults Following a Major Burn Injury Phase 4
Completed NCT03113253 - TRANexamic Acid to Reduce Bleeding in BURN Surgery Phase 4
Recruiting NCT04090424 - Assessment of Safety and Effectiveness of NovoSorb® BTM in Severe Burns N/A
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Withdrawn NCT03159182 - Study of Silicone Material Inserts To Treat Burn Scars N/A
Recruiting NCT02904941 - Human Amniotic Versus Synthetic Membrane as a Transient Skin Cover for Pediatric Burns N/A
Completed NCT02681757 - Comparison of Mepitel Ag vs Antibiotic Ointment Used With Soft Cast Technique for Treatment of Pediatric Burns N/A
Recruiting NCT01812941 - Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients N/A
Completed NCT01437852 - StrataGraft® Skin Tissue as an Alternative to Autografting Deep Partial-Thickness Burns Phase 1
Completed NCT01214811 - Open Multi-centre Investigation to Evaluate Signs and Symptoms of Local Inflammation/Infection on Chronic Ulcers and Partial Thickness Burns When Using Mepilex Border Ag as an Anti-microbial Wound Dressing Phase 3
Completed NCT01061502 - Efficacy Study of a Bioelectric Dressing to Treat Skin Graft Donor Site Wounds Phase 1/Phase 2
Terminated NCT00822796 - Thermogard™ Efficacy Trial N/A
Terminated NCT00824681 - Effect of Music Therapy on Families of Burn Patients Phase 1
Terminated NCT00634166 - Effects of Therapy With Sulfamylon® 5% Topical Solution Compared to a Historical Control Group Phase 4
Terminated NCT00464386 - Continuous Glucose Monitoring (POC) in the ICU N/A
Withdrawn NCT00216983 - Proline Metabolism in Severely Burned Patients: Effect of Modulated Parenteral Feeding N/A