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Comparison Study of Wound Closure at Time of Cesarean Delivery: Dermabond Glue Versus Surgical Staples

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00524511
Recruitment Status : Terminated (Poor enrollment, much data was missing as patients were lost to follow up)
First Posted : September 3, 2007
Results First Posted : March 5, 2013
Last Update Posted : March 5, 2013
Sponsor:
Information provided by (Responsible Party):
Dawn Tasillo, University of Massachusetts, Worcester

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cesarean Section
Interventions Device: Surgical skin staples
Device: Dermabond
Enrollment 136
Recruitment Details September 4, 2007-July 9, 2010 Recruitment occured in the medical clinics and Labor and Delivery unit of an academic medical center
Pre-assignment Details The study design dictates that patients be enrolled upon admission to Labor and Delivery. Subsequently, patients who did not deliver by cesarean delivery would be excluded
Arm/Group Title Group Receiving Alternative Skin Closure Method (Dermabond) Group Receiving Standard Skin Closure Method (Surgical Staples
Hide Arm/Group Description Women receiving Dermabond for skin closure Women receiving standard surgical skin staples
Period Title: Overall Study
Started 68 68
Completed 64 61
Not Completed 4 7
Arm/Group Title Group Receiving Alternative Skin Closure Method (Dermabond) Group Receiving Standard Skin Closure Method (Surgical Staples Total
Hide Arm/Group Description Women receiving Dermabond for skin closure Women receiving standard surgical skin staples Total of all reporting groups
Overall Number of Baseline Participants 68 68 136
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants 68 participants 136 participants
<=18 years
1
   1.5%
0
   0.0%
1
   0.7%
Between 18 and 65 years
67
  98.5%
68
 100.0%
135
  99.3%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants 68 participants 136 participants
Female
68
 100.0%
68
 100.0%
136
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Wound Complication Rate
Hide Description Wound seroma or hematoma, wound separation, wound requiring packing, cellulitis, required extra medical clinic visits to evaluate wound
Time Frame within six weeks of study intervention
Hide Outcome Measure Data
Hide Analysis Population Description
No participants were analyzed due to poor enrollment, subjects lost to follow-up and incomplete/partial data.
Arm/Group Title Group Receiving Alternative Skin Closure Method (Dermabond) Group Receiving Standard Skin Closure Method (Surgical Staples
Hide Arm/Group Description:
Women receiving Dermabond for skin closure
Women receiving standard surgical skin staples
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Patient Satisfaction of Cosmesis of Surgical Wound
Hide Description survey questionnaire using a visual analog scale to inquire about incision appearance, satisfaction with method of closure and comparison to previous closure type (if applicable)
Time Frame before hospital discharge after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
No participants were analyzed due to poor enrollment, subjects lost to follow-up and incomplete/partial data.
Arm/Group Title Group Receiving Alternative Skin Closure Method (Dermabond) Group Receiving Standard Skin Closure Method (Surgical Staples
Hide Arm/Group Description:
Women receiving Dermabond for skin closure
Women receiving standard surgical skin staples
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group Receiving Alternative Skin Closure Method (Dermabond) Group Receiving Standard Skin Closure Method (Surgical Staples
Hide Arm/Group Description Women receiving Dermabond for skin closure Women receiving standard surgical skin staples
All-Cause Mortality
Group Receiving Alternative Skin Closure Method (Dermabond) Group Receiving Standard Skin Closure Method (Surgical Staples
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Group Receiving Alternative Skin Closure Method (Dermabond) Group Receiving Standard Skin Closure Method (Surgical Staples
Affected / at Risk (%) Affected / at Risk (%)
Total   0/68 (0.00%)   0/68 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group Receiving Alternative Skin Closure Method (Dermabond) Group Receiving Standard Skin Closure Method (Surgical Staples
Affected / at Risk (%) Affected / at Risk (%)
Total   0/68 (0.00%)   0/68 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dawn Tasillo, MD
Organization: UMass Memorial Medical Center
Phone: 5083346255
EMail: tasillod@ummhc.org
Layout table for additonal information
Responsible Party: Dawn Tasillo, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT00524511    
Other Study ID Numbers: 12462
First Submitted: August 31, 2007
First Posted: September 3, 2007
Results First Submitted: October 24, 2012
Results First Posted: March 5, 2013
Last Update Posted: March 5, 2013