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Cesarean SectionNCT01217567

Subcuticular Suture Versus Staples for Closure of the Skin After Caesarean Section.

A study testing Staples left, subcuticular suture right and Subcuticular suture left side and staples right in people with Cesarean Section and Cicatrix, run by Holbaek Sygehus at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The Purpose of this study is to compare two methods for closure of the skin after caesarean section on the same patient; staples and subcuticular sutures. The study is performed on two separate groups of patients: 1. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Cesarean Section, Cicatrix
What is being tested?
Staples left, subcuticular suture right and Subcuticular suture left side and staples right
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteDenmark
Study dates
Mar 2010to Jan 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Woman having elective or level III caesarean section. Level III caesarean section is defined as being ordered more than 30 minutes before surgery is started.
  • Woman who speak and understand Danish
  • Woman who can give informed consent.

Who cannot join

  • Level I or II caesarean section (ordered less than 30 min. before surgery is started).
  • Diabetics (this does not include gestational diabetes).
  • Infection
  • Regular treatment with immunosuppressives
  • Alcohol or drug abuse
  • Age under 18
Show all 9Show fewer
  • Chronic pain disease eg fibromyalgia, rheumatoid arthritis
  • BMI over 35
  • Previous abdominal surgery through lower transverse abdominal incision (only applicable to woman having caesarean section for the first time).

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Department of Gynaechology and Obstetrics, Holbæk Sygehus

    Holbæk, 4300

Other trials in Denmark

About this study

Official title: Subcuticular Suture Versus Staples for Closure of the Skin After Caesarean Section: A Prospective Randomized Single-blinded Case-Control Study With the Case as it's Own Control.

The Purpose of this study is to compare two methods for closure of the skin after caesarean section on the same patient; staples and subcuticular sutures. The study is performed on two separate groups of patients: 1. Woman having cesarean section for the first time and have not previously had abdominal surgery through a lower abdominal transverse incision. 2. Woman, who have previously had a caesarean section done. The following parameters are registered:

  1. An objective evaluation of the two ends of the scar 6 months postoperatively.
  2. A patient evaluation of the two ends of the scar 6 months postoperatively.
  3. The difference in pain in the two ends of the scar 1 day postoperatively (blinded).
  4. The difference in pain in the two ends of the scar 7 days, 3 and 6 months postoperatively.
  5. The rate of infection.
Being tested
Staples left, subcuticular suture right, Subcuticular suture left side and staples right
Keywords
cicatrix, cesarean section, sutures, surgical staples, postoperative pain, Infection
Medical subject headings
Cicatrix, Pain, Postoperative, Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Staples left, subcuticular suture rightProcedure or surgery

    Closure of the skin after cesarean section with staples on the left side of the wound and subcuticular suture on the right side.

  • Subcuticular suture left side and staples rightProcedure or surgery

    Closure of the skin after cesarean section with staples on the right side of the wound and subcuticular suture on the left side.

Study groups in NCT01217567
Study groupRoleWhat they receive
1st c-section, no previous lower abdominal surgery - s.l.ExperimentalNot described
Receives: Procedure: Staples left, subcuticular suture right
Woman with previous ceasarean section - staples leftExperimentalNot described
Receives: Procedure: Staples left, subcuticular suture right
1st c-section, no previous lower abdominal surgeryExperimentalNot described
Receives: Procedure: Subcuticular suture left side and staples right
Woman with previous ceasarean sectionExperimentalNot described
Receives: Procedure: Subcuticular suture left side and staples right

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Preferred side of the caesarean section scar

    Preferred side of the scar and thereby method for closure of the skin: Staples, subcuticular suture or no difference.

    Measured: 6 months postoperatively

Secondary outcomes (8)

  1. The difference in pain between the two ends of the scar

    Difference in painscore between the two ends of the scar 1st and 7th postoperative day. Pain is registered by a score on a vas-scale from 0-10.

    Measured: 1 and 7 days postoperatively

  2. The difference in pain between the two ends of the scar

    Difference in painscore between the two ends of the scar 3 and 6 months postoperatively. Pain is registered by a score on a vas-scale from 0-10.

    Measured: 3 and 6 months postoperatively

  3. Pain in the two ends of the scar

    Pain in the two ends of the scar registered by a score on a vas-scale from 0-10 1 and 7 days postoperatively.

    Measured: 1 and 7 days postoperatively

  4. Pain in the two ends of the scar

    Pain in the two ends of the scar registered by a score on a vas-scale from 0-10 3 and 6 months postoperatively.

    Measured: 3 and 6 months postoperatively

  5. Infection

    The rate of postoperative infection and what side of the scar - right or left -that is infected.

    Measured: 7 days postoperatively

  6. Infection

    The rate of postoperative infection and what side of the scar - right or left -that is infected.

    Measured: 3 and 6 months postoperatively

  7. Cosmetic objective evaluation of the two ends of the scar

    Evaluation of the right and left side of the scar respectively by two blinded doctors using the Singer's "scar evaluation scale" . Difference in Singer's score between the two ends of the scar.

    Measured: 6 months postoperatively

  8. Comparison of outcome measures in woman with no previous abdominal surgery and woman with previous caesarean section.

    Primay and Secondary outcome measures are compared in the two groups of patients.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2010 (estimated)
  2. Study startMar 2010
  3. Primary completionJul 2011
  4. Study completionJan 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01217567
Sponsor's protocol ID
Cicatricestudiet
Other IDs
SJ-162
Status last verified
Feb 2012
First submitted
7 Oct 2010
Last updated
8 Feb 2012
Results posted
No
Data monitoring committee
No

Publications

  • The CAESAR study: http://www.npeu.ox.ac.uk/caesar

  • 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.

    PubMed 14520211

  • CORONIS Trial Collaborative Group. The CORONIS Trial. International study of caesarean section surgical techniques: a randomised fractional, factorial trial. BMC Pregnancy Childbirth. 2007 Oct 22;7:24. doi: 10.1186/1471-2393-7-24.

    PubMed 18336721

  • Altman AD, Allen VM, McNeil SA, Dempster J. Pfannenstiel incision closure: a review of current skin closure techniques. J Obstet Gynaecol Can. 2009 Jun;31(6):514-520. doi: 10.1016/S1701-2163(16)34213-X.

    PubMed 19646316

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

    PubMed 9350017

  • Gaertner I, Burkhardt T, Beinder E. Scar appearance of different skin and subcutaneous tissue closure techniques in caesarean section: a randomized study. Eur J Obstet Gynecol Reprod Biol. 2008 May;138(1):29-33. doi: 10.1016/j.ejogrb.2007.07.003. Epub 2007 Sep 6.

    PubMed 17825472

  • Singer AJ, Arora B, Dagum A, Valentine S, Hollander JE. Development and validation of a novel scar evaluation scale. Plast Reconstr Surg. 2007 Dec;120(7):1892-1897. doi: 10.1097/01.prs.0000287275.15511.10.

    PubMed 18090752

  • Rousseau JA, Girard K, Turcot-Lemay L, Thomas N. A randomized study comparing skin closure in cesarean sections: staples vs subcuticular sutures. Am J Obstet Gynecol. 2009 Mar;200(3):265.e1-4. doi: 10.1016/j.ajog.2009.01.019.

    PubMed 19254586

  • 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.

    PubMed 12804476

  • Johnson A, Young D, Reilly J. Caesarean section surgical site infection surveillance. J Hosp Infect. 2006 Sep;64(1):30-5. doi: 10.1016/j.jhin.2006.03.020. Epub 2006 Jul 5.

    PubMed 16822582

  • Cromi A, Ghezzi F, Gottardi A, Cherubino M, Uccella S, Valdatta L. Cosmetic outcomes of various skin closure methods following cesarean delivery: a randomized trial. Am J Obstet Gynecol. 2010 Jul;203(1):36.e1-8. doi: 10.1016/j.ajog.2010.02.001. Epub 2010 Apr 24.

    PubMed 20417924

  • Aabakke AJM, Krebs L, Pipper CB, Secher NJ. Subcuticular suture compared with staples for skin closure after cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2013 Oct;122(4):878-884. doi: 10.1097/AOG.0b013e3182a5f0c3.

    PubMed 24084548

Questions about this trial

What is this clinical trial studying?

A study testing Staples left, subcuticular suture right and Subcuticular suture left side and staples right in people with Cesarean Section and Cicatrix, run by Holbaek Sygehus at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Preferred side of the caesarean section scar (time frame: 6 months postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01217567, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2012.

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