INSORB Versus Subcuticular Sutures at Cesarean Section

Stopped early · Phase 1

Conditions studied: Cesarean Section, Pregnancy

In brief

The proposed study is a randomized controlled trial with two arms. All patients admitted to Labor and Delivery at Johns Hopkins Hospital for delivery will be approached and offered entry into our study. Once the patient is enrolled, and if she undergoes a cesarean section, the patient will be randomized at time of cesarean section to receive skin closure by either the INSORB™ absorbable staples or subcuticular closure using Biosyn™ suture as is the standard practice. Both an observer scar assessment score (OSAS) and patient scar assessment score (PSAS) will be obtained during this visit. The patient will then be contacted by telephone by a study member 3 months after her surgery for a brief survey (same PSAS survey) assessing her satisfaction with the resulting scar.

Key facts

Study ID
NCT01687972
Run by
Johns Hopkins University
People needed
187
Starts
2011-09-01
Expected to finish
2012-08-01
Last updated by the study team
2018-04-02

Who can join

Age: 16 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

You may not qualify if…

Where it is running

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.