Health TrialsbyHealthPanel

Post-Operative Cesarean Section Cosmesis

ConditionCesarean Delivery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-44
SponsorWake Forest University Health Sciences

About this trial

Given the high numbers of cesarean deliveries being performed today, there has been interest in optimizing surgical techniques. Several recent reviews have summarized the evidence for various steps of cesarean delivery, but surprisingly in many cases there is little scientific evidence on which to base the choice of surgical technique.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 18-44

Any race

Any parity

Scheduled cesarean section

Disqualifiers

Non-English Speaking

Incarcerated

Maternal Connective Tissue Disorder

Systemic maternal steroid use

Trial design

Design model

Parallel

Treatments tested in this trial

  • absorbable subcuticular polyglycolic acid staples (INSORB)

    Procedure/Surgery

    Insorb absorbable staples are used for skin closure

  • subcuticular, polyglecaprone suture (Monocryl)

    Procedure/Surgery

    Monocryl absorbable staples are used for skin closure

Treatment groups

52 Participants
are divided into 2 treatment groups
Group A: subcuticular absorbable polyglycolic acid (INSORB) staplesActive comparator 1 intervention
Group B: subcuticular absorbable polyglecaprone suture (Monocryl)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

scar cosmetic score

Scars will be digitally photographed by study staff and scored by 2 independent judges (attending Obstetricians) according to the SCAR scale validated by Kantor with scores ranging from 0 (best) to 15 (worst).

Time frame
Week 6

Secondary outcomes

1

Number of Wound complications

wound complications (infection, dehiscence, seroma, hematoma, skin and fat necrosis, skin and fascial dehiscence)

Time frame
Week 6
2

length of hospital stay

days spent in hospital

Time frame
Week 6
3

amount of in-hospital intravenous opiate analgesic use

amount of in-hospital intravenous opiate analgesic use

Time frame
Week 6
4

amount of in-hospital oral NSAID analgesic use

amount of in-hospital oral NSAID analgesic use

Time frame
Week 6

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wake Forest University Health Sciences

Lead sponsor

Source ClinicalTrials.gov
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