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The purpose of the study is to compare post operative pain, cost effectiveness, speed of closure and patient satisfaction of Pfannenstiel incisions closed with metallic staples versus absorbable staples (Insorb) after Cesarean Delivery.
The ideal method of closing the skin following a Pfannenstiel incision has not yet been established. Presently, the method of skin closure is a matter of the surgeon's personal preference. Currently, there is limited evidence regarding which method is considered "superior" in terms of post operative pain, patient satisfaction, and cost effectiveness. This information would be incredibly valuable in helping guide surgeons in their choice of skin closure technique; and with the rates of Cesarean deliveries rapidly rising, it is important to determine the best method of skin closure in order to optimize patient care.
After a patient is consented she will be randomized into either the control group and receive the standard metallic staples or the experimental group and receive the absorbable staples for her skin closure procedure. One day after her procedure the RN will ask the patient to rate her pain using a 10cm VAS pain scale. Two or three days after the skin closure and before the patient is discharged a short survey about the patient's satisfaction of her scar appearance will be administered. The PI will go back and review the patient's chart to determine the amount of narcotics administered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Placebo Comparator | This group will receive the standard metallic staples to close their incision. |
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| Case Group | Experimental | This group will receive the Insorb absorbable staples to close their incision. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insorb absorbable staples | Device | Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples |
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| Measure | Description | Time Frame |
|---|---|---|
| Post Operative Pain | Post operative pain at post operative day #1 will be measured using the Visual Analogue Scale (VAS). The scale has a minimum score of 0 representing no pain and a maximum score of 10 representing the worst possible pain. | 1 Year |
| Post Operative Pain (3 Days Post-op) | Post operative pain at the time of discharge will be measured using the Visual Analogue Scale (VAS). The scale has a minimum score of 0 representing no pain and a maximum score of 10 representing the worst possible pain. | 1 Year |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction | Patients will be given a survey prior to being discharged to assess their satisfaction with the appearance of their scar. The survey asked whether patients "strongly agree," "agree," "disagree," or "strongly disagree" with the statement, "I am satisfied with the overall appearance of my incision." Those who responsed "agree" or "strongly agree" were said to be satisfied with the appearance and the outcome is reported as number of participants who were satisfied. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Good Samaritan Hospital | Cincinnati | Ohio | 45220 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23921089 | Result | Feese CA, Johnson S, Jones E, Lambers DS. A randomized trial comparing metallic and absorbable staples for closure of a Pfannenstiel incision for cesarean delivery. Am J Obstet Gynecol. 2013 Dec;209(6):556.e1-5. doi: 10.1016/j.ajog.2013.08.001. Epub 2013 Aug 3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | This group will receive the standard metallic staples to close their incision. Insorb absorbable staples: Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples |
| FG001 | Case Group | This group will receive the Insorb absorbable staples to close their incision. Insorb: Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Completed Surgery -Received Intervention |
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| Completed VAS Score Postop Day 1 |
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| Completed VAS Score at Discharge |
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| Survey Prior to Discharge |
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| 6 Week Post-partum Survey |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | This group will receive the standard metallic staples to close their incision. Insorb absorbable staples: Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples |
| BG001 | Case Group |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Post Operative Pain | Post operative pain at post operative day #1 will be measured using the Visual Analogue Scale (VAS). The scale has a minimum score of 0 representing no pain and a maximum score of 10 representing the worst possible pain. | Posted | Mean | Standard Error | units on a scale | 1 Year |
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Duration of study: July 2010 - May 2011 (10 months).
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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 | Control Group | This group will receive the standard metallic staples to close their incision. Insorb absorbable staples: Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples |
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Low response rate to patient surveys at discharge and at 6 weeks postpartum.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Donna Lambers, MD | TriHealth | 513-862-2828 | donna_lambers@trihealth.com |
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| Insorb | Device | Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples |
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| This will be assessed 3 day after the patient's C-section before they are discharged from the hospital |
| Patient Satisfaction | Patients will be given a survey at their 6 week post-op visit to assess their satisfaction with the appearance of their scar. The survey asked whether patients "strongly agree," "agree," "disagree," or "strongly disagree" with the statement, "I am satisfied with the overall appearance of my incision." Those who responsed "agree" or "strongly agree" were said to be satisfied with the appearance and the outcome is reported as number of participants who were satisfied. | Patient satisfaction will be assessed 6 weeks later at their post-op visit |
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This group will receive the Insorb absorbable staples to close their incision. Insorb: Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Primary | Post Operative Pain (3 Days Post-op) | Post operative pain at the time of discharge will be measured using the Visual Analogue Scale (VAS). The scale has a minimum score of 0 representing no pain and a maximum score of 10 representing the worst possible pain. | Posted | Mean | Standard Deviation | units on a scale | 1 Year |
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| Secondary | Patient Satisfaction | Patients will be given a survey prior to being discharged to assess their satisfaction with the appearance of their scar. The survey asked whether patients "strongly agree," "agree," "disagree," or "strongly disagree" with the statement, "I am satisfied with the overall appearance of my incision." Those who responsed "agree" or "strongly agree" were said to be satisfied with the appearance and the outcome is reported as number of participants who were satisfied. | Posted | Number | participants | This will be assessed 3 day after the patient's C-section before they are discharged from the hospital |
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| Secondary | Patient Satisfaction | Patients will be given a survey at their 6 week post-op visit to assess their satisfaction with the appearance of their scar. The survey asked whether patients "strongly agree," "agree," "disagree," or "strongly disagree" with the statement, "I am satisfied with the overall appearance of my incision." Those who responsed "agree" or "strongly agree" were said to be satisfied with the appearance and the outcome is reported as number of participants who were satisfied. | Posted | Number | participants | Patient satisfaction will be assessed 6 weeks later at their post-op visit |
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| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Case Group | This group will receive the Insorb absorbable staples to close their incision. Insorb: Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples | 0 | 50 | 0 | 50 |
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