Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00282633
Status:
UNKNOWN
Last Update Posted:
2007-10-31
First Post:
2006-01-25
Brief Title:
Wound Closure Techniques
Sponsor:
Hartford Hospital
Organization:
Hartford Hospital
Study Overview
Official Title:
A Comparison of Skin Closure Techniques After Primary Cesarean Delivery
Status:
UNKNOWN
Status Verified Date:
2007-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A Comparison of Skin Closure Techniques after Primary Cesarean Delivery Traci N Gray MD and Peter F Schnatz DO
A prospective observer blinded randomized and controlled trial comparing Dermabond closure technique to suture closure of skin
Study Participants All women age 18years or older who provide informed consent prior to primary Cesarean delivery at Hartford Hospital Women with vertical skin incisions and or who are febrile preop or intraop will be excluded
Methods Qualified participants will then be randomized to skin closure with either Dermabond or suture Surgeon preference will dictate usage of 4-0 monocryl or 4-0 vicryl for skin closure for patients randomized to the suture arm
The circulating nurse will time all skin closures
The surgeon will complete a 3 question survey immediately postop
At the 6 week post partum visit patients and the health care professional will complete a brief query regarding cosmetic appeal and pain A disposable camera will be supplied to each provider office and a photo will be taken of the incision
All photos will be evaluated for cosmesis by physicians who will be blinded to the methods of skin closure
Primary Outcomes To compare the time needed to close skin To compare cosmetic outcome after healing
Secondary Outcomes Patient Pain scores Provider and patient satisfaction Responses to questions
A prospective observer blinded randomized and controlled trial comparing Dermabond closure technique to suture closure of skin
Study Participants All women age 18years or older who provide informed consent prior to primary Cesarean delivery at Hartford Hospital Women with vertical skin incisions and or who are febrile preop or intraop will be excluded
Methods Qualified participants will then be randomized to skin closure with either Dermabond or suture Surgeon preference will dictate usage of 4-0 monocryl or 4-0 vicryl for skin closure for patients randomized to the suture arm
The circulating nurse will time all skin closures
The surgeon will complete a 3 question survey immediately postop
At the 6 week post partum visit patients and the health care professional will complete a brief query regarding cosmetic appeal and pain A disposable camera will be supplied to each provider office and a photo will be taken of the incision
All photos will be evaluated for cosmesis by physicians who will be blinded to the methods of skin closure
Primary Outcomes To compare the time needed to close skin To compare cosmetic outcome after healing
Secondary Outcomes Patient Pain scores Provider and patient satisfaction Responses to questions
Detailed Description:
Introduction
Much of the practice of surgical wound closure and subsequent care is based upon tradition and individual preference rather than science Most patients undergoing cesarean deliveries at Hartford Hospital have a subcuticular running closure Occasionally patients have a staple closure at the discretion of the operating surgeon With newly introduced wound closure techniques we intend to compare an approved closure technique Dermabond with the more traditional suture closure via a prospective observer blinded randomized controlled trial
Methods
Study participants will include all women who provide informed consent prior to undergoing cesarean section at Hartford Hospital Patients will be excluded from the study if they will require a vertical skin incision are allergic to Dermabond or have a temperature 1002 F preop or intraop Qualified patients will then be randomized to skin closure with either the Dermabond wound closure technique or suture
Closure method randomization will be performed prospectively by placing closure modality options in opaque sealed envelopes prior to the initiation of the study The envelopes will be available in the operating room The circulating nurse will open the envelope to reveal the randomization arm prior to skin closure and the surgeon will utilize the indicated technique The circulating nurse will record the length of time needed to close the skin incision The surgeon will complete a short survey immediately post operatively regarding ease of use of the closure modality as well as expected cosmetic outcome
If a patient is randomized to suture surgeon preference will dictate whether 4-0 vicryl or 4-0 monocryl will be used as well as whether Keith or curved needle will be utilized Patient demographics and contact information will be obtained prior to initiation of the procedure
Prior to initiation of surgery the operative field will be prepared by dry shaving the site with a disposable razor then cleansing the abdomen with Betadine using sterile technique Hibiclens soap will be substituted for patients who are sensitive or allergic to iodine A first generation Cephalosporin will be administered 30 minutes preop for patients undergoing scheduled cesarean delivery If the procedure is unscheduled a first generation Cephalosporin will be administered after cord clamp if the patient has not already received antibiotics preoperatively
The patients post operative pain medicine requirements and pain self assessment scores will be monitored during their post operative hospital course as documented in the medication logs on their charts Most patients will be discharged on postoperative day three or four unless complications arise
All patients will be seen in the office for a 6-week post partum follow up A medical professional will assess their wounds The patient and the medical professional will be queried regarding their satisfaction with cosmetic outcome of the wound The patient will also be queried regarding continued pain medicine requirements If the patient does not show up for their post partum visit they will be called to obtain this information and to arrange a time for follow-up
Each medical professional will be provided with a disposable camera The camera will be used to take pictures of each patients wound at the 6-week follow up visit Specific guidelines will be provided regarding the distance and angle at which the pictures should be taken to ensure optimal and uniform photo clarity The pictures will be reviewed at a later time by a panel of observers who will be blinded to the type of wound closure that the patient received The observer will assess each picture for wound cosmesis and healing to provide standardized objective evaluation of wound closure outcomes
Power and Sample Size
The primary outcomes will be surgical time wound closure only patient satisfaction and blinded observer-rated cosmesis Using a 13 randomization scheme group sample sizes of 25 testDermabond and 75 controlsuture would achieve 80 power to detect a difference of 10 between the null hypothesis that both group means for satisfaction and cosmesis are 30 average and the alternative hypothesis that the mean of the Dermabond group is 20 above average with estimated group standard deviations of 15 and with a significance level alpha of 005 using a two-sided two-sample t-test
Assuming the average closure time for the suture group is 6 minutes SD -1 and hypothesizing an average closure time in the Dermabond group of 15 minutes SD - 05 minutes these sample sizes would afford better than 99 power to detect differences in surgical closure time between the two groups
The Womens Health Department at Hartford Hospital performs an average of 12 procedures per week range 10-15 If 70 of the eligible women consent to participate it should take approximately 12 weeks to accrue the minimum number of subjects However if the participation rate is 80-85 only 10-11 weeks should be required for accrual
Data Analysis Statistics
Descriptive statistics on continuous variables eg height weight maternal age gestational age surgical closure time will consist of means standard deviations and 95 confidence intervals Frequencies of race and ethnicity also will be run To evaluate the primary outcomes between treatment arms differences in closure time patient satisfaction and observed healing t-tests will be utilized Subgroup comparisons eg within the suture group between curved and Keith needles also will be performed with t-tests Secondary analyses of dichotomous yesno variables including surgeon responses to Did you find this method effective and Did you find this method burdensome will be evaluated with a c2 test Although infections may occur and will be noted the rate is anticipated to be so low that statistical assessment will not be necessary Statistically significant differences will be considered as analyses resulting in p005 All analyses will be performed with SPSS v 115 Chicago IL 2003
Much of the practice of surgical wound closure and subsequent care is based upon tradition and individual preference rather than science Most patients undergoing cesarean deliveries at Hartford Hospital have a subcuticular running closure Occasionally patients have a staple closure at the discretion of the operating surgeon With newly introduced wound closure techniques we intend to compare an approved closure technique Dermabond with the more traditional suture closure via a prospective observer blinded randomized controlled trial
Methods
Study participants will include all women who provide informed consent prior to undergoing cesarean section at Hartford Hospital Patients will be excluded from the study if they will require a vertical skin incision are allergic to Dermabond or have a temperature 1002 F preop or intraop Qualified patients will then be randomized to skin closure with either the Dermabond wound closure technique or suture
Closure method randomization will be performed prospectively by placing closure modality options in opaque sealed envelopes prior to the initiation of the study The envelopes will be available in the operating room The circulating nurse will open the envelope to reveal the randomization arm prior to skin closure and the surgeon will utilize the indicated technique The circulating nurse will record the length of time needed to close the skin incision The surgeon will complete a short survey immediately post operatively regarding ease of use of the closure modality as well as expected cosmetic outcome
If a patient is randomized to suture surgeon preference will dictate whether 4-0 vicryl or 4-0 monocryl will be used as well as whether Keith or curved needle will be utilized Patient demographics and contact information will be obtained prior to initiation of the procedure
Prior to initiation of surgery the operative field will be prepared by dry shaving the site with a disposable razor then cleansing the abdomen with Betadine using sterile technique Hibiclens soap will be substituted for patients who are sensitive or allergic to iodine A first generation Cephalosporin will be administered 30 minutes preop for patients undergoing scheduled cesarean delivery If the procedure is unscheduled a first generation Cephalosporin will be administered after cord clamp if the patient has not already received antibiotics preoperatively
The patients post operative pain medicine requirements and pain self assessment scores will be monitored during their post operative hospital course as documented in the medication logs on their charts Most patients will be discharged on postoperative day three or four unless complications arise
All patients will be seen in the office for a 6-week post partum follow up A medical professional will assess their wounds The patient and the medical professional will be queried regarding their satisfaction with cosmetic outcome of the wound The patient will also be queried regarding continued pain medicine requirements If the patient does not show up for their post partum visit they will be called to obtain this information and to arrange a time for follow-up
Each medical professional will be provided with a disposable camera The camera will be used to take pictures of each patients wound at the 6-week follow up visit Specific guidelines will be provided regarding the distance and angle at which the pictures should be taken to ensure optimal and uniform photo clarity The pictures will be reviewed at a later time by a panel of observers who will be blinded to the type of wound closure that the patient received The observer will assess each picture for wound cosmesis and healing to provide standardized objective evaluation of wound closure outcomes
Power and Sample Size
The primary outcomes will be surgical time wound closure only patient satisfaction and blinded observer-rated cosmesis Using a 13 randomization scheme group sample sizes of 25 testDermabond and 75 controlsuture would achieve 80 power to detect a difference of 10 between the null hypothesis that both group means for satisfaction and cosmesis are 30 average and the alternative hypothesis that the mean of the Dermabond group is 20 above average with estimated group standard deviations of 15 and with a significance level alpha of 005 using a two-sided two-sample t-test
Assuming the average closure time for the suture group is 6 minutes SD -1 and hypothesizing an average closure time in the Dermabond group of 15 minutes SD - 05 minutes these sample sizes would afford better than 99 power to detect differences in surgical closure time between the two groups
The Womens Health Department at Hartford Hospital performs an average of 12 procedures per week range 10-15 If 70 of the eligible women consent to participate it should take approximately 12 weeks to accrue the minimum number of subjects However if the participation rate is 80-85 only 10-11 weeks should be required for accrual
Data Analysis Statistics
Descriptive statistics on continuous variables eg height weight maternal age gestational age surgical closure time will consist of means standard deviations and 95 confidence intervals Frequencies of race and ethnicity also will be run To evaluate the primary outcomes between treatment arms differences in closure time patient satisfaction and observed healing t-tests will be utilized Subgroup comparisons eg within the suture group between curved and Keith needles also will be performed with t-tests Secondary analyses of dichotomous yesno variables including surgeon responses to Did you find this method effective and Did you find this method burdensome will be evaluated with a c2 test Although infections may occur and will be noted the rate is anticipated to be so low that statistical assessment will not be necessary Statistically significant differences will be considered as analyses resulting in p005 All analyses will be performed with SPSS v 115 Chicago IL 2003
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None