Staples Versus Dermabond for Closure of the Skin After Cesarean Section
This study is enrolling participants by invitation only.
Sponsor:
Meir Medical Center
Information provided by:
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01261715
First received: December 6, 2010
Last updated: December 15, 2010
Last verified: October 2010
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 6, 2010 | ||||
| Last Updated Date | December 15, 2010 | ||||
| Start Date ICMJE | January 2011 | ||||
| Estimated Primary Completion Date | February 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Cosmetic objective evaluation of the scar [ Time Frame: 6 weeks postoperatively ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01261715 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Staples Versus Dermabond for Closure of the Skin After Cesarean Section | ||||
| Official Title ICMJE | Staples Versus Dermabond for Closure of the Skin After Cesarean Section | ||||
| Brief Summary | Two of the more frequently used options for skin closure following a cesarean delivery include staples or sutures (stitches). Another method of closure is Dermabond- liquid skin adhesive. This method of closure is used less frequently than either staples or sutures. Few studies have been done regarding whether Dermabond is preferable or affect the outcome of a cesarean section surgery. The aim of our study is to find weather Dermabond haas better result for the closure of cesarean section wounds. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Cesarean Section Wound | ||||
| Intervention ICMJE | Procedure: Dermabond- liquid skin adhesive
Dermabond- liquid skin adhesive |
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| Study Arm (s) | Active Comparator: Woman with previous ceasarean section - staples
Intervention: Procedure: Dermabond- liquid skin adhesive |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Enrollment ICMJE | 50 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | February 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Woman over 18 year Woman having elective caesarean section Exclusion Criteria: Age under 18 Woman having an emergency caesarean section |
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01261715 | ||||
| Other Study ID Numbers ICMJE | 155-2010 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Sadeh Dana MD, Meir Medical Center | ||||
| Study Sponsor ICMJE | Meir Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Meir Medical Center | ||||
| Verification Date | October 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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