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| Sponsored by: |
St. Joseph's Healthcare |
| Information provided by: | St. Joseph's Healthcare |
| ClinicalTrials.gov Identifier: | NCT00186732 |
Purpose
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.
| Condition | Intervention |
|
Pain, Postoperative Gynecologic Surgical Procedures Obstetric Surgical Procedures |
Procedure: Subcuticular Suture Procedure: Surgical Staples |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Pfannenstiel Incision Closure: Subcuticular Suture Versus Surgical Staples |
| Estimated Enrollment: | 288 |
| Study Start Date: | July 2005 |
| Estimated Study Completion Date: | November 2006 |
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.
Eligibility
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contacts and Locations| Contact: Cara Donnery, M.D | cara.donnery@learnlink.mcmaster.ca | |
| Contact: Richard Persadie, M.D. | (905) 522-1155 ext 6041 | richardpersadie@hotmail.com |
| Canada, Ontario | |||||
| St. Joseph's Healthcare | Recruiting | ||||
| Hamilton, Ontario, Canada, L8N 4A6 | |||||
| Contact: Cara A Donnery, MD cara.donnery@learnlink.mcmaster.ca | |||||
| Contact: Richard Persadie, MD (905) 522-1155 ext 6041 richardpersadie@hotmail.com | |||||
| Principal Investigator: Cara A Donnery, MD | |||||
| Principal Investigator: Richard Persadie, MD | |||||
| St. Joseph's Healthcare |
| Principal Investigator: | Cara A Donnery, MD | McMaster University Obstetrics and Gynecology Resident |
| Principal Investigator: | Richard Persadie, MD | Staff Doctor: St. Joseph's Healthcare, Hamilton |
More Information
| Study ID Numbers: | 05-2484 |
| First Received: | September 12, 2005 |
| Last Updated: | June 11, 2007 |
| ClinicalTrials.gov Identifier: | NCT00186732 |
| Health Authority: | Canada: Health Canada |
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