Skin Closures at Cesarean Delivery, Glue vs Subcuticular Sutures.

Cesarean Wound; Dehiscence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04371549
• Other study ID #: 2
• Status: Completed
• Phase: N/A
• Start date: August 25, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: November 2022
• Source: Ain Shams Maternity Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: March 1, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cesarean Wound; Dehiscence

Intervention

Procedure:
• Glue (Dermabond®; Ethicon, Somerville, NJ).
Arm 1: Skin after cesarean section will be closed by glue
• Monocryl
Arm 2: Skin after cesarean section will be closed by running subcuticular sutures using synthetic absorbable monofilament

Locations

Country	Name	City	State
Egypt	AinShams university maternity hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital

Country where clinical trial is conducted

Egypt, 

References & Publications (14)

ACOG Practice Bulletin No. 199 Summary: Use of Prophylactic Antibiotics in Labor and Delivery. Obstet Gynecol. 2018 Sep;132(3):798-800. doi: 10.1097/AOG.0000000000002834. — View Citation

Altman R, Bosch B, Brune K, Patrignani P, Young C. Advances in NSAID development: evolution of diclofenac products using pharmaceutical technology. Drugs. 2015 May;75(8):859-77. doi: 10.1007/s40265-015-0392-z. Review. — View Citation

Bhende S, Rothenburger S, Spangler DJ, Dito M. In vitro assessment of microbial barrier properties of Dermabond topical skin adhesive. Surg Infect (Larchmt). 2002 Fall;3(3):251-7. — View Citation

Blanchette H. The rising cesarean delivery rate in America: what are the consequences? Obstet Gynecol. 2011 Sep;118(3):687-690. doi: 10.1097/AOG.0b013e318227b8d9. — View Citation

Bruns TB, Worthington JM. Using tissue adhesive for wound repair: a practical guide to dermabond. Am Fam Physician. 2000 Mar 1;61(5):1383-8. Review. — View Citation

Clay FS, Walsh CA, Walsh SR. Staples vs subcuticular sutures for skin closure at cesarean delivery: a metaanalysis of randomized controlled trials. Am J Obstet Gynecol. 2011 May;204(5):378-83. doi: 10.1016/j.ajog.2010.11.018. Epub 2010 Dec 31. — View Citation

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. — View Citation

Daykan Y, Sharon-Weiner M, Pasternak Y, Tzadikevitch-Geffen K, Markovitch O, Sukenik-Halevy R, Biron-Shental T. Skin closure at cesarean delivery, glue vs subcuticular sutures: a randomized controlled trial. Am J Obstet Gynecol. 2017 Apr;216(4):406.e1-406.e5. doi: 10.1016/j.ajog.2017.01.009. Epub 2017 Jan 30. — View Citation

Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. — View Citation

Siddiqui DS, Lacuna EM, Chen HY, Chauhan SP. Skin closure of pfannenstiel incision with dermabond, staples, or suture during cesarean delivery: experience of a single attending. Am J Perinatol. 2013 Mar;30(3):219-24. doi: 10.1055/s-0032-1323583. Epub 2012 Aug 8. — View Citation

Singer AJ, Hollander JE, Quinn JV. Evaluation and management of traumatic lacerations. N Engl J Med. 1997 Oct 16;337(16):1142-8. Review. — View Citation

Singer AJ, Quinn JV, Clark RE, Hollander JE; TraumaSeal Study Group. Closure of lacerations and incisions with octylcyanoacrylate: a multicenter randomized controlled trial. Surgery. 2002 Mar;131(3):270-6. — View Citation

Truong PT, Lee JC, Soer B, Gaul CA, Olivotto IA. Reliability and validity testing of the Patient and Observer Scar Assessment Scale in evaluating linear scars after breast cancer surgery. Plast Reconstr Surg. 2007 Feb;119(2):487-94. — View Citation

van de Kar AL, Corion LU, Smeulders MJ, Draaijers LJ, van der Horst CM, van Zuijlen PP. Reliable and feasible evaluation of linear scars by the Patient and Observer Scar Assessment Scale. Plast Reconstr Surg. 2005 Aug;116(2):514-22. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Patient and Observer Scar Assessment Scale (POSASv2.0):	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
Primary	The Patient and Observer Scar Assessment Scale (POSASv2.0):	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	Surgeons' satisfaction scale:	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
Secondary	Duration of surgery	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