NCT03063853

Brief Summary

The optimal choice of skin closure at cesarean delivery has not yet been determined. This study aim to study the wound complications and scar healing after Surgical staples removal at postoperative day 4 and day 8 . A randomized control trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 24, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2017

Completed
Last Updated

May 8, 2018

Status Verified

February 1, 2017

Enrollment Period

9 months

First QC Date

February 22, 2017

Last Update Submit

May 2, 2018

Conditions

Cesarean Section; Wound, Infection (Following Delivery)

Outcome Measures

Primary Outcomes (1)

  • Patient and Observer Scar Assessment Scale (POSAS) scores.

    8 weeks postoperative

Secondary Outcomes (1)

  • complications of surgical site infection (SSI) or wound disruption (hematoma or seroma).

    8 weeks postoperative

Study Arms (2)

POD4

OTHER

REMOVAL OF SURGICAL STAPLES AT POSTOPERATIVE DAY 4

Other: Removal of surgical clips at day 4 post operative vs day 8 post operativeProcedure: Elective cesarean delivery

POD8

OTHER

REMOVAL OF SURGICAL STAPLES AT POSTOPERATIVE DAY 8

Other: Removal of surgical clips at day 4 post operative vs day 8 post operativeProcedure: Elective cesarean delivery

Interventions

Removal of surgical clips at day 4 post operative vs day 8 post operativeOTHER

Removal of surgical clips at day 4 post operative vs day 8 post operative

POD4POD8
Elective cesarean deliveryPROCEDURE

non emergent elective cesarean delivery

POD4POD8

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • elective cesarean delivery
  • previous cesarean delivery performed using the Pfannenstiel method
  • weeks of gestation based on first trimester ultrasound and a viable fetus.

You may not qualify if:

  • emergency cesarean delivery
  • clinical signs of infection at the time of CD, uncontrolled
  • vunblanaced diabetes mellitus
  • history of keloids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wolfson medical center

Holon, Israel

Location

MeSH Terms

Conditions

Wounds and InjuriesInfections

Study Officials

  • Hadas Miremberg, MD

    Wolfson Medical Center- Tel Aviv University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2017

First Posted

February 24, 2017

Study Start

February 1, 2017

Primary Completion

October 30, 2017

Study Completion

October 30, 2017

Last Updated

May 8, 2018

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)