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Optimal Time for Staple/Dressing Removal

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01724255
First Posted: November 9, 2012
Last Update Posted: July 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hadassah Medical Organization
  Purpose

The medical literature does not provide sufficient information or recommendation regarding the optimal time to remove the staples and the bandage after a cesarean section. The goal of this study is to compare 5 groups of patients:

  1. staple removal on POD 4 and dressing removal on Post Operative Day (POD)1
  2. staple removal on POD 4 and dressing removal on Post Operative Day (POD)4
  3. staple removal on POD 7 and dressing removal on Post Operative Day (POD)1
  4. staple removal on POD 7 and dressing removal on Post Operative Day (POD)7
  5. staple removal on POD 4 and dressing removal on Post Operative Day (POD)7

Since there is no definite protocol for staple and dressing removal, we will adapt the above protocol each for a 3-4 month period of time. Patients will be contacted to either return for a follow up visit or to answer a telephone survey.


Condition Intervention
Surgical Wound Healing Surgical Wound Infection Patient Satisfaction Other: questionnaire

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Influence of the Timing of Staple and Dressing Removal After Cesarean Section on the Surgical Incision Healing

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Incidence of Wound infection and complications [ Time Frame: 6 weeks ]

Enrollment: 1500
Study Start Date: January 2013
Study Completion Date: December 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
staple removal day 4 dressing removal day 1
early staple removal and early dressing removal
Other: questionnaire
staple removal day 4 dressing removal day 4
early staple removal and day 4 dressing removal
Other: questionnaire
staple removal day 7, dressing removal day 1
late staple removal and early dressing removal
Other: questionnaire
staple removal day 7, dressing removal day 7
late staple removal and late dressing removal
Other: questionnaire
staple removal day 7, dressing removal day 4
late staple removal and day 4 dressing removal
Other: questionnaire

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients undergoing a cesarean section at our facility
Criteria

Inclusion Criteria:

  • patients undergoing a cesarean section at our facility

Exclusion Criteria:

  • patients lost to follow up
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01724255


Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Drorith Hochner-Celnikier, MD Hadassah Medical Organization
  More Information

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01724255     History of Changes
Other Study ID Numbers: StapleDressingRemoval-HMO-CTIL
First Submitted: November 7, 2012
First Posted: November 9, 2012
Last Update Posted: July 28, 2015
Last Verified: July 2015

Keywords provided by Hadassah Medical Organization:
Caesarian section
Surgical Wound

Additional relevant MeSH terms:
Wounds and Injuries
Wound Infection
Surgical Wound
Surgical Wound Infection
Infection
Postoperative Complications
Pathologic Processes