Optimal Time for Staple/Dressing Removal

This study is currently recruiting participants.
Verified January 2013 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01724255
First received: November 7, 2012
Last updated: January 13, 2013
Last verified: January 2013
  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 4 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

Since there is no definite protocol for staple and dressing removal, we will adapt the above protocol each for a 3 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1500
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 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, dressign removal day 7
late staple removal and late dressing removal
Other: questionnaire

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01724255

Contacts
Contact: Drorith Hochner-Celnikier, MD 00 972 2 5844000 hochner@hadassah.org.il

Locations
Israel
Hadassah Medical Organization Recruiting
Jerusalem, Israel
Contact: Hadas Lemberg, PhD    00 972 2 6777572    lhadas@hadassah.org.il   
Principal Investigator: Drorith Hochner-Celnikier, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Drorith Hochner-Celnikier, MD Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01724255     History of Changes
Other Study ID Numbers: StapleDressingRemoval-HMO-CTIL
Study First Received: November 7, 2012
Last Updated: January 13, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
Caesarian section
Surgical Wound

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

ClinicalTrials.gov processed this record on April 17, 2014