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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03063853

Acronym

ROCD

Enrollment

104

Registered

2017-02-24

Start date

2017-02-01

Completion date

2017-10-30

Last updated

2018-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section; Wound, Infection (Following Delivery)

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.

Detailed description

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%.

Interventions

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

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

PROCEDUREElective cesarean delivery

non emergent elective cesarean delivery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Patient and Observer Scar Assessment Scale (POSAS) scores.	8 weeks postoperative

Secondary

Measure	Time frame
complications of surgical site infection (SSI) or wound disruption (hematoma or seroma).	8 weeks postoperative

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026