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Instilled Lidocaine vs Placebo for Pain Management During Vacuum Assisted Closure (VAC) Dressing Changes

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ClinicalTrials.gov Identifier: NCT00585325
Recruitment Status : Completed
First Posted : January 3, 2008
Results First Posted : March 7, 2018
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition: Burn
Interventions: Drug: Instilled 1% Lidocaine
Other: Placebo (0.9% Normal Saline)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 15 patients were enrolled with 41 VAC dressing changes. Patients could be enrolled into more than one arm.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Units Details
Units for given values
Values given as pairs: 1) number of participants and 2) number of units (VAC dressing changes)

Reporting Groups
  Description
Instilled 1% Lidocaine 5 mg/kg of 1% lidocaine instilled into their VAC sponge ½ hour prior to VAC dressing change
Instilled Placebo (0.9% Normal Saline) receive .9 normal saline instilled into their VAC sponge ½ hour prior to VAC dressing change

Participant Flow:   Overall Study
    Instilled 1% Lidocaine   Instilled Placebo (0.9% Normal Saline)
Participants Units (VAC dressing changes) Participants Units (VAC dressing changes)
STARTED   10   20   13   21 
COMPLETED   9   14   12   18 
NOT COMPLETED   1      1    
Withdrawal by Subject                1                                1                 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Instilled 1% Lidocaine 5 mg/kg of 1% lidocaine instilled into their VAC sponge ½ hour prior to VAC dressing change
Instilled Placebo (0.9% Normal Saline) receive .9 normal saline instilled into their VAC sponge ½ hour prior to VAC dressing change
Total Total of all reporting groups

Baseline Measures
   Instilled 1% Lidocaine   Instilled Placebo (0.9% Normal Saline)   Total 
Overall Participants Analyzed 
[Units: Participants]
 9   12   21 
Overall Units Analyzed (VAC dressing changes) 
[Units: VAC dressing changes]
 14   18   32 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      8  88.9%      10  83.3%      18  85.7% 
>=65 years      1  11.1%      2  16.7%      3  14.3% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      7  77.8%      6  50.0%      13  61.9% 
Male      2  22.2%      6  50.0%      8  38.1% 
Region of Enrollment 
[Units: Participants]
     
United States   9   12   21 


  Outcome Measures

1.  Primary:   Pain During Dressing Change   [ Time Frame: During dressing change ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Cindy Schmitz, RN, MS, NP
Organization: University of Wisconsin-Madison
phone: 608-262-2664
e-mail: CSchmitz@uwhealth.org



Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00585325     History of Changes
Other Study ID Numbers: H-2004-0106
First Submitted: December 26, 2007
First Posted: January 3, 2008
Results First Submitted: December 13, 2017
Results First Posted: March 7, 2018
Last Update Posted: March 7, 2018