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Poor enrollment, much data was missing as patients were lost to follow up
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Women who have a cesarean delivery have a surgical incision on their abdomen (belly). The usual way to close this opening is with metal surgical staples. In many other types of surgery, surgical incisions are closed with a super-glue called Dermabond. The researchers at the University of Massachusetts believe Dermabond may be a safe alternative to using staples at the time of a cesarean delivery, but this has not been studied. Women who choose to participate will be randomly assigned to have the cesarean delivery skin incision closed with staples or Dermabond. The researchers will survey the patients to see how they felt about the experience and the appearance of their scar. The researchers will survey physicians performing the surgery to see how easy Dermabond was to use. The researchers will ask physicians to evaluate the appearance of the incision after a 6-week recovery period and will analyze complications (such as bruising, infection, or separation of the wound) in the two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Women receiving Dermabond for skin closure |
|
| 2 | Active Comparator | Women receiving standard surgical skin staples |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical skin staples | Device | Standard method to close abdominal surgical wounds |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Wound Complication Rate | Wound seroma or hematoma, wound separation, wound requiring packing, cellulitis, required extra medical clinic visits to evaluate wound | within six weeks of study intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction of Cosmesis of Surgical Wound | 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) | before hospital discharge after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dawn S Tasillo, MD | University of Massachusetts, Worcester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMass Memorial Medical Center | Worcester | Massachusetts | 01604 | United States |
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
September 4, 2007-July 9, 2010 Recruitment occured in the medical clinics and Labor and Delivery unit of an academic medical center
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| ID | Title | Description |
|---|---|---|
| FG000 | Group Receiving Alternative Skin Closure Method (Dermabond) | Women receiving Dermabond for skin closure |
| FG001 | Group Receiving Standard Skin Closure Method (Surgical Staples | Women receiving standard surgical skin staples |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group Receiving Alternative Skin Closure Method (Dermabond) | Women receiving Dermabond for skin closure |
| BG001 | Group Receiving Standard Skin Closure Method (Surgical Staples |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Wound Complication Rate | Wound seroma or hematoma, wound separation, wound requiring packing, cellulitis, required extra medical clinic visits to evaluate wound | No participants were analyzed due to poor enrollment, subjects lost to follow-up and incomplete/partial data. | Posted | within six weeks of study intervention |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group Receiving Alternative Skin Closure Method (Dermabond) | Women receiving Dermabond for skin closure |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dawn Tasillo, MD | UMass Memorial Medical Center | 5083346255 | tasillod@ummhc.org |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D014014 | Tissue Adhesives |
| ID | Term |
|---|---|
| D001697 | Biomedical and Dental Materials |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D053831 | Surgical Fixation Devices |
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| Dermabond |
| Device |
Alternative method (superglue) to close abdominal surgical wounds |
|
|
Women receiving standard surgical skin staples
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Secondary | Patient Satisfaction of Cosmesis of Surgical Wound | 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) | No participants were analyzed due to poor enrollment, subjects lost to follow-up and incomplete/partial data. | Posted | before hospital discharge after surgery |
|
|
| 0 |
| 68 |
| 0 |
| 68 |
| EG001 | Group Receiving Standard Skin Closure Method (Surgical Staples | Women receiving standard surgical skin staples | 0 | 68 | 0 | 68 |
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| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |