Skin Closures at Cesarean Delivery, Glue vs Subcuticular Sutures.

November 20, 2022 updated by: Ahmed Mohammed Elmaraghy, Ain Shams Maternity Hospital

Skin Closures at Cesarean Delivery, Glue vs Subcuticular Sutures: A Randomized Clinical Trial

The optimal choice of skin closure at cesarean delivery has not yet been determined. This study will compare wound complications and scar healing following cesarean delivery between 2 methods of skin closure: glue (Dermabond®; Ethicon, Somerville, NJ) and monofilament (Monocryl®; Ethicon) epidermal sutures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cesarean delivery (CD) rates have increased during the last few decades and it has become the most common surgery during women's reproductive years . However, despite its prevalence, data regarding many aspects of the preferred surgical technique are sparse. Skin closure is an integral step of CD. It influences postoperative pain, wound healing, cosmetic outcome, and surgeon and patient satisfaction There is currently no definite evidence regarding the best method for skin closure after cesarean delivery. Staples have been suggested as inferior to other techniques . Given the conflicting data available, obstetricians are forced to base their decisions on personal preference. Dermabond® glue (Ethicon Inc, Somerville, NJ) is a liquid monomer that forms a strong tissue bond with a protective barrier that adds strength and inhibits bacteria. An in vitro study found that glue inhibits both gram-positive (methicillin-resistant Staphylococcus aureus and Staphylococcus epidermidis) and gram-negative (Escherichia coli) bacteria . In addition, glue has the potential advantages of rapid application and repair time. It has been shown to achieve cosmetically similar results compared to staples within 12 months of the repair. Also, glue was shown to be well-accepted by patients .

To date, there have been no randomized clinical trials comparing skin closure with glue to sutures using the Patient and Observer Scar Assessment Scale (POSAS). The POSAS is a validated and reliable instrument that is practical for assessing scars . It is comprehensive and correlates well with patient ratings. The Observer Scar Assessment Scale rates 5 variables: vascularity, pigmentation, thickness, relief, and pliability. Each variable is ranked from 1-10, with 1 representing normal skin. Ratings are summed to obtain a total score ranging from 5-50. The Patient Scar Assessment Scale consists of 6 items: scar-related pain, itchiness, color, stiffness, thickness, and irregularity. Each item is ranked from 1-10, with 1 representing normal skin. Total score ranges from 6-60.

Previous studies regarding skin closure with glue were small, retrospective, and included mixed populations and varying surgical techniques. Therefore, clear, conclusive recommendations are lacking.

Dermabond® is a liquid monomeric (2-octyl cyanoacrylate) formulation that undergoes an exothermic reaction upon exposure to moisture, changing to polymers that form a strong tissue bond. The wound will not be dressed with an abdominal pad or adhesive tape according to manufacturer's instructions.

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ainshams University maternity hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Maternal Age: 20-40 years old.
  • BMI: 18.5 - 29.9 kg/m2.
  • Gestational Age: term pregnancy (≥ 37 weeks) and viable fetus.
  • Scheduled to undergo elective lower segment CD (category 4 CD).
  • Hemoglobin level: ≥ 10 gm/dl.

Exclusion Criteria:

  • Abnormal placental invasion (e.g., placenta previa).
  • Emergency CD (category 1, 2 and 3 CD).
  • Clinical signs of infection at the time of CD.
  • Medical disorder (Diabetes, Hypertension, Cardiac, Hepatic or renal disorder).
  • Uterine anomalies (e.g., septum, Mullerian anomalies or fibroids).
  • Previous CD not using Pfannenstiel method (e.g., midline incision).
  • Known hypersensitivity to any of the suture materials or glue used in the protocol, or any disorders requiring chronic corticosteroids or immune suppressants.
  • History of surgical site infection after previous CD.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Glue
Skin closure after cesarean section using glue
Procedure: Glue (Dermabond®; Ethicon, Somerville, NJ).
Arm 1: Skin after cesarean section will be closed by glue
Active Comparator: Monocryl
Skin closure after cesarean section using running subcuticular sutures using synthetic monofilament
Procedure: Monocryl
Arm 2: Skin after cesarean section will be closed by running subcuticular sutures using synthetic absorbable monofilament

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Patient and Observer Scar Assessment Scale (POSASv2.0):
Time Frame: one week after cesarean section
In the POSASv2.0 observers rate vascularity, pigmentation, pliability, thickness, relief and surface area. The directions for use of the different parameters of the Observer Scale POSASv2.0 are as follows (all parameters should be compared to normal skin at a comparable anatomical site whenever possible):The Patient Scale contains six questions applying to pain, itching, colour, pliability, thickness and relief.Each of the six items on both scales has a 10-point score, with 10 indicating the worst imaginable scar or sensation. The lowest score is '1' and corresponds to the situation of normal skin (normal pigmentation, no itching etc.), and goes up to the worst imaginable
one week after cesarean section
The Patient and Observer Scar Assessment Scale (POSASv2.0):
Time Frame: one month after cesarean section
In the POSASv2.0 observers rate vascularity, pigmentation, pliability, thickness, relief and surface area. The directions for use of the different parameters of the Observer scale POSASv2.0 are as follows ( all parameters should be compared to normal skin at a comparable anatomical site whenever possible): The Patient scale contains six questions applying to pain, itching, colour, pliability, thickness and relief. Each of the six items on both scales has a 10-point score, with 10 indicating the worst imaginable scar or sensation. The lowest score is 1 and correspons to the situation of normal skin( normal pigmentation, no itching etc.) and goes up to the worst imaginable
one month after cesarean section

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgeons' satisfaction scale:
Time Frame: immediately after the procedure
Surgeons' satisfaction scale with each closure method (glue vs sutures) is based on 3 questions asked immediately upon completion of surgery: (1) How comfortable were you with the technique? (not at all [1] to totally comfortable [5]); (2) Was the estimated total operating time longer using glue compared to skin closure with sutures? (not at all [1] to yes, a lot longer [5]); and (3) Were you satisfied with the final closure appearance? (not at all [1] to yes, very satisfied [5])
immediately after the procedure
Duration of surgery
Time Frame: in minutes from closure of the subcutaneous fat layer to closure of the skin
the duration of skin closure using glue or Monocryl will be measures in minutes
in minutes from closure of the subcutaneous fat layer to closure of the skin

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams Maternity Hospital

Investigators

  • Principal Investigator: Mahmoud K Mohammed, M.B.B.Ch, AinShams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2020

Primary Completion (Actual)

January 31, 2021

Study Completion (Actual)

March 1, 2021

Study Registration Dates

First Submitted

April 27, 2020

First Submitted That Met QC Criteria

April 30, 2020

First Posted (Actual)

May 1, 2020

Study Record Updates

Last Update Posted (Actual)

November 22, 2022

Last Update Submitted That Met QC Criteria

November 20, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 2 (Other Identifier: Instituto Cardiovascular de Buenos Aires)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cesarean Wound; Dehiscence

Clinical Trials on Glue (Dermabond®; Ethicon, Somerville, NJ).

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe