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Completed

NCT Number: NCT03063853

Removal of Surgical Staples After Cesarean Delivery. Randomized Control Trial.

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.

Completed

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Key information

Conditions

Cesarean Section; Wound, Infection (Following Delivery) Infections Wounds and Injuries

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Wolfson medical center

Holon, Israel

About this study

A randomized controlled trial in which pregnant women undergoing a scheduled Elective cesarean delivery were assigned to skin closure with surgical staples and were randomly assigned to the day of removal of surgical staples. Postoperative day 4 VS. Postoperative day 8 .

Outcome assessors were blinded to group allocation. Scars will be evaluated after 8 weeks. Primary outcome measures is Patient and Observer Scar Assessment Scale (POSAS) scores. Secondary outcome measures are complications of surgical site infection (SSI) or wound disruption (hematoma or seroma).

A group of 104 women is needed in order to achieve a clinically significant effect with a power of 80%.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • elective cesarean delivery
  • previous cesarean delivery performed using the Pfannenstiel method
  • 36-41 weeks of gestation based on first trimester ultrasound and a viable fetus.

Exclusion criteria

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

Treatment and study plan

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

Other

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

Elective cesarean delivery

Procedure

non emergent elective cesarean delivery

Primary outcomes

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

    Time frame: 8 weeks postoperative

Secondary outcomes

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

    Time frame: 8 weeks postoperative

Sponsors and collaborators

Lead sponsor

Wolfson Medical Center

Other Gov

Registry information

Official study title

Early Versus Late Removal of Surgical Staples After Cesarean Delivery. Randomized Control Trial.

Acronym: ROCD

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 24, 2017
Registry last updated
May 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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