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| Descriptive Information Fields | |||||||||
| Brief Title † | Comparison of Subcuticular Suture Versus Surgical Staples for Closure of Pfannenstiel Skin Incisions | ||||||||
| Official Title † | Pfannenstiel Incision Closure: Subcuticular Suture Versus Surgical Staples | ||||||||
| Brief Summary | This study compares methods of closure for Pfannenstiel incisions commonly used during gynecological and obstetrical surgery. Patients are assigned to closure by either surgical staples or a buried suture. Information is collected on the day of surgery, post-operative day two and at the six-week follow up visit. The amount of pain and cosmetic result are compared. Infection rates will also be monitored for the two groups. The study hypothesis is as follows: subcuticular (buried) sutures as compared to surgical staples lead to decreased post-operative pain and improved cosmetic result. Infection rates are similar for both groups. |
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| Detailed Description | There is little evidence in the literature to guide the choice of closure material for Pfannenstiel laparotomy. Currently this decision is based primarily on physician preference. Physicians differ greatly in their view on which is better. This is based on personal habit and experience and not on scientific evidence. Specifically in the field of obstetrics and gynecology there has only been one randomized trial of approximately 60 patients undergoing cesarean section comparing subcuticular suture vs surgical staples for closure of their Pfannenstiel skin incisions (Frishman et al., 1997). This study showed that Pfannenstiel skin incisions closed with subcuticular closure following cesarean section result in less postoperative pain and are more cosmetically appealing as compared to incisions closed with staples. This randomized controlled study will compare closure of Pfannenstiel incisions using either subcuticular absorbable suture or surgical staples. It will examine two separate populations – those undergoing cesarean section and those undergoing gynecological surgery such as hysterectomy. These patient groups will be analyzed separately as their demographic characteristics tend to be quite different. The primary outcome will be postoperative pain. Cosmetic result will be a secondary outcome. Cosmesis will be rated both by the patient and the physician. Infection rates are also of great interest although it is unlikely that this study will achieve adequate power to show a statistically significant difference in results. Other outcomes of interest include overall patient satisfaction, total operating room time and length of hospital stay. Patient’s body mass index will also be recorded and analyzed to determine whether it affects results in both intervention groups. There will be a minimum of 144 patients total in the cesarean section group and 144 patients total in the gynecological surgery group – 72 randomized to staples and 72 randomized to subcuticular suture for each group. Thus the entire study will involve approximately 288 patients. |
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| Study Phase | |||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | Pain | ||||||||
| Secondary Outcome Measure † | Cosmesis Infection rates Length of stay OR time Overall patient satisfaction |
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| Condition † | Pain, Postoperative Gynecologic Surgical Procedures Obstetric Surgical Procedures |
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| Intervention † | Procedure: Subcuticular Suture Procedure: Surgical Staples |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 288 | ||||||||
| Start Date † | July 2005 | ||||||||
| Completion Date | November 2006 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
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| Gender | Female | ||||||||
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| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | Canada | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00186732 | ||||||||
| Organization ID | 05-2484 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | St. Joseph's Healthcare | ||||||||
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| Information Provided By | St. Joseph's Healthcare | ||||||||
| Verification Date | September 2005 | ||||||||
| First Received Date † | September 12, 2005 | ||||||||
| Last Updated Date | June 11, 2007 | ||||||||
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