NCT00186732

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
288

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

August 11, 2011

Status Verified

August 1, 2011

First QC Date

September 12, 2005

Last Update Submit

August 10, 2011

Conditions

Pain, PostoperativeGynecologic Surgical ProceduresObstetric Surgical Procedures

Keywords

wound closurePfannenstiel incisionsurgical staplessubcuticular suture

Outcome Measures

Primary Outcomes (1)

  • Pain

Secondary Outcomes (4)

  • Cosmesis

  • Infection rates

  • Length of stay OR time

  • Overall patient satisfaction

Interventions

Subcuticular SuturePROCEDURE
Surgical StaplesPROCEDURE

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Undergoing gynecological or obstetrical surgery
  • Pfannenstiel skin incision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph's Healthcare

Hamilton, Ontario, L8N 4A6, Canada

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Sutures

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Study Officials

  • Cara A Donnery, MD

    McMaster University Obstetrics and Gynecology Resident

    PRINCIPAL INVESTIGATOR

  • Richard Persadie, MD

    Staff Doctor: St. Joseph's Healthcare, Hamilton

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

July 1, 2005

Study Completion

June 1, 2007

Last Updated

August 11, 2011

Record last verified: 2011-08

Locations

CA(1)