Comparison of Subcuticular Suture Versus Surgical Staples for Closure of Pfannenstiel Skin Incisions

Pain, Postoperative Clinical Trial

Official title:

Pfannenstiel Incision Closure: Subcuticular Suture Versus Surgical Staples

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00186732
• Other study ID #: 05-2484
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: August 10, 2011
• Start date: July 2005
• Est. completion date: June 2007

Study information

• Verified date: August 2011
• Source: St. Joseph's Healthcare Hamilton
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Undergoing gynecological or obstetrical surgery

• Pfannenstiel skin incision

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gynecologic Surgical Procedures
• Obstetric Surgical Procedures
• Pain, Postoperative

Intervention

Procedure:
• Subcuticular Suture

• Surgical Staples

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain
Secondary	Cosmesis
Secondary	Infection rates
Secondary	Length of stay OR time
Secondary	Overall patient satisfaction