Optimal Time for Staple/Dressing Removal

This study is currently recruiting participants. (see Contacts and Locations)
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
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, see Learn About Clinical Studies.

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 August 21, 2014