NCT01724255

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

July 28, 2015

Status Verified

July 1, 2015

Enrollment Period

1.7 years

First QC Date

November 7, 2012

Last Update Submit

July 26, 2015

Conditions

Surgical Wound HealingSurgical Wound InfectionPatient Satisfaction

Keywords

Caesarian sectionSurgical Wound

Outcome Measures

Primary Outcomes (1)

  • Incidence of Wound infection and complications

    6 weeks

Study Arms (5)

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

Interventions

questionnaireOTHER
staple removal day 4 dressing removal day 1staple removal day 4 dressing removal day 4staple removal day 7, dressing removal day 1staple removal day 7, dressing removal day 4staple removal day 7, dressing removal day 7

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All patients undergoing a cesarean section at our facility

You may qualify if:

  • patients undergoing a cesarean section at our facility

You may not qualify if:

  • patients lost to follow up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

Location

Related Publications (1)

  • Heinemann N, Solnica A, Abdelkader R, Gutman J, Nalbandian N, Raizman E, Hochner-Celnikier D. Timing of staples and dressing removal after cesarean delivery (the SCARR study). Int J Gynaecol Obstet. 2019 Mar;144(3):283-289. doi: 10.1002/ijgo.12757. Epub 2019 Jan 11.

    PMID: 30582610DERIVED

MeSH Terms

Conditions

Surgical Wound InfectionPatient SatisfactionSurgical Wound

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsTreatment Adherence and ComplianceHealth BehaviorBehaviorWounds and Injuries

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Drorith Hochner-Celnikier, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2012

First Posted

November 9, 2012

Study Start

January 1, 2013

Primary Completion

October 1, 2014

Study Completion

December 1, 2014

Last Updated

July 28, 2015

Record last verified: 2015-07

Locations

IL(1)