NCT00293683

Brief Summary

We hypothesize that the use of absorbable staples to close cesarean skin incisions will cause less pain, have better long-term cosmetic results, and result in improved patient satisfaction over standard metal staples. We expect to see no difference in wound complication rates with these two cesarean skin closure techniques.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

December 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 17, 2006

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

July 29, 2014

Status Verified

July 1, 2014

Enrollment Period

9.8 years

First QC Date

February 16, 2006

Last Update Submit

July 28, 2014

Conditions

Cesarean Section

Keywords

cesareanclosureskinstapleabsorbablemetal

Outcome Measures

Primary Outcomes (1)

  • Post operative pain

Secondary Outcomes (6)

  • Length of time of skin closure

  • Costs

  • Cosmetic outcome

  • Wound disruption rate

  • Infection rate

  • +1 more secondary outcomes

Interventions

Insorb absorbable skin stapleDEVICE

Eligibility Criteria

Age12 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients at TJUH undergoing primary cesarean delivery via Pfannenstiel incision
  • Surgeon willing to adhere to randomized skin staple category

You may not qualify if:

  • Known allergy to staples or suture
  • Vertical skin incision
  • Repeat cesarean deliveries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (6)

  • Frishman GN, Schwartz T, Hogan JW. Closure of Pfannenstiel skin incisions. Staples vs. subcuticular suture. J Reprod Med. 1997 Oct;42(10):627-30.

    PMID: 9350017BACKGROUND

  • Ranaboldo CJ, Rowe-Jones DC. Closure of laparotomy wounds: skin staples versus sutures. Br J Surg. 1992 Nov;79(11):1172-3. doi: 10.1002/bjs.1800791122.

    PMID: 1467895BACKGROUND

  • Alderdice F, McKenna D, Dornan J. Techniques and materials for skin closure in caesarean section. Cochrane Database Syst Rev. 2003;(2):CD003577. doi: 10.1002/14651858.CD003577.

    PMID: 12804476BACKGROUND

  • Fick JL, Novo RE, Kirchhof N. Comparison of gross and histologic tissue responses of skin incisions closed by use of absorbable subcuticular staples, cutaneous metal staples, and polyglactin 910 suture in pigs. Am J Vet Res. 2005 Nov;66(11):1975-84. doi: 10.2460/ajvr.2005.66.1975.

    PMID: 16334959BACKGROUND

  • Pickford IR, Brennan SS, Evans M, Pollock AV. Two methods of skin closure in abdominal operations: a controlled clinical trial. Br J Surg. 1983 Apr;70(4):226-8. doi: 10.1002/bjs.1800700414.

    PMID: 6338996BACKGROUND

  • Zwart HJ, de Ruiter P. Subcuticular, continuous and mechanical skin closure: cosmetic results of a prospective randomized trial. Neth J Surg. 1989 Jun;41(3):57-60. No abstract available.

    PMID: 2501713BACKGROUND

Study Officials

  • Jason K. Baxter, MD, MSCP

    Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2006

First Posted

February 17, 2006

Study Start

December 1, 2004

Primary Completion

October 1, 2014

Study Completion

December 1, 2014

Last Updated

July 29, 2014

Record last verified: 2014-07

Locations

US(1)