A Clinical Trial of Subcuticular Staples Versus Subcuticular Suture for Cesarean Section Skin Closure

NCT01753518 | Completed Results

• 1 other identifier: 12-003183
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

Currently, the way doctors close the skin during cesarean section is different between surgeons and there is little evidence to support the use of one kind of closure over the other. At the Mayo Clinic Family Birth Center, skin is currently closed using an absorbable suture (or stitch), placed within the top layer of skin. At other institutions, a metal staple is often used to close the skin. There is a new technique that uses special absorbable staples just beneath the skin. This technology may be equal to, or possibly better than, current skin closure techniques. However, there is currently little data to show how it compares. The purpose of this study is to compare the absorbable staple to the currently used absorbable suture. The data from this study will then be used to help determine the best technique for skin closure.

Conditions

Surgical Wound

Keywords

Subcuticular suture; Subcuticular staple; Skin closure; Incision closure; Wound

Outcome Measures

Primary Outcomes (2)

• Total Surgical Time, All Resident Levels

  Total surgical time was defined as the time from incision start to incision completion. Measured for all resident education levels (1 to 4 years postgraduate).

  Measured at the time of the procedure (day 1), approximately 1 hour after incision start

• Skin Closure Time, All Resident Levels

  Measured for all resident education levels (1 to 4 years postgraduate).

  Measured at the time of the procedure (day 1), approximately 1 hour after incision start

Secondary Outcomes (7)

• Total Number of Participants With Postoperative Complications

  From the day of the procedure (Day 1) for 6 weeks

• Participants With Postoperative Complications, by Type

  From the day of the procedure (Day 1) for 6 weeks

• Postoperative Pain

  From day of procedure until end of hospital stay (typical dismissal on day 4)

• Number of Subjects Requiring Patient-controlled, Alternative Oral, or Single Dose IV/IM Analgesic

  From day of procedure until end of hospital stay (typical dismissal on day 4)

• Patient Satisfaction

  At the time of dismissal (typically day 3 or 4) and at 6 weeks postoperative appointment

Study Arms (2)

Subcuticular suture

ACTIVE COMPARATOR

Subcuticular suture has been used for many years to close skin incisions.

Device: Subcuticular suture

Subcuticular staple

ACTIVE COMPARATOR

Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.

Device: Subcuticular staple

Interventions

Subcuticular suture DEVICE

subcuticular Monocryl suture closure

Also known as: Monocryl

Subcuticular suture

Subcuticular staple DEVICE

subcuticular staple wound closure with INSORB 20 device

Also known as: Insorb

Subcuticular staple

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Gestational age ≥ 24 weeks
• Scheduled cesarean section for any indication
• Pfannenstiel incision
• Singleton gestation

You may not qualify if:

• Failure to consent
• Gestational age \< 24 weeks
• Vaginal delivery
• Intrauterine fetal death
• Multifetal gestation
• Suspected infection, i.e. chorioamnionitis
• BMI \> 50

Sponsors & Collaborators

• Margaret L. Dow, M.D.: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (5)

• Tuuli MG, Rampersad RM, Carbone JF, Stamilio D, Macones GA, Odibo AO. Staples compared with subcuticular suture for skin closure after cesarean delivery: a systematic review and meta-analysis. Obstet Gynecol. 2011 Mar;117(3):682-690. doi: 10.1097/AOG.0b013e31820ad61e.

  PMID: 21343772 BACKGROUND

• Jagger J, Bentley M, Tereskerz P. A study of patterns and prevention of blood exposures in OR personnel. AORN J. 1998 May;67(5):979-81, 983-4, 986-7 passim. doi: 10.1016/s0001-2092(06)62623-9.

  PMID: 9592605 BACKGROUND

• Jenkins TR. It's time to challenge surgical dogma with evidence-based data. Am J Obstet Gynecol. 2003 Aug;189(2):423-7. doi: 10.1067/s0002-9378(03)00587-8.

  PMID: 14520211 BACKGROUND

• Berghella V, Baxter JK, Chauhan SP. Evidence-based surgery for cesarean delivery. Am J Obstet Gynecol. 2005 Nov;193(5):1607-17. doi: 10.1016/j.ajog.2005.03.063.

  PMID: 16260200 BACKGROUND

• Walsh CA. Evidence-based cesarean technique. Curr Opin Obstet Gynecol. 2010 Apr;22(2):110-5. doi: 10.1097/GCO.0b013e3283372327.

  PMID: 20216417 BACKGROUND

MeSH Terms

Conditions

Surgical Wound; Wounds and Injuries

Limitations and Caveats

The data are limited by the lack of diversity, and there may be racial or genetic differences in wound healing confounding the results. This trial was not powered for postoperative wound complications.

Results Point of Contact

• Title: Dr. Margaret Dow
• Organization: Mayo Clinic

dow.margaret@mayo.edu

507-266-8008

Study Officials

• Jennifer Tessmer-Tuck, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: December 5, 2012
• First Posted: December 20, 2012
• Study Start: November 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: June 1, 2014
• Last Updated: April 30, 2015
• Results First Posted: April 30, 2015

Record last verified: 2015-04

Locations

US (1)