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

This study has been completed.
Sponsor:
Information provided by:
St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier:
NCT00186732
First received: September 12, 2005
Last updated: August 10, 2011
Last verified: August 2011
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pfannenstiel Incision Closure: Subcuticular Suture Versus Surgical Staples

Further study details as provided by St. Joseph's Healthcare Hamilton:

Primary Outcome Measures:
  • Pain

Secondary Outcome Measures:
  • Cosmesis
  • Infection rates
  • Length of stay OR time
  • Overall patient satisfaction

Estimated Enrollment: 288
Study Start Date: July 2005
Study Completion Date: June 2007
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Undergoing gynecological or obstetrical surgery
  • Pfannenstiel skin incision
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00186732

Locations
Canada, Ontario
St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N 4A6
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
Investigators
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

No publications provided

ClinicalTrials.gov Identifier: NCT00186732     History of Changes
Other Study ID Numbers: 05-2484
Study First Received: September 12, 2005
Last Updated: August 10, 2011
Health Authority: Canada: Health Canada

Keywords provided by St. Joseph's Healthcare Hamilton:
wound closure
Pfannenstiel incision
surgical staples
subcuticular suture

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014