Recruiting

Dermabond & Suture

Sponsor:

Hartford Hospital

Code:

NCT00282633

Conditions

Wounds, Closure

Eligibility Criteria

Sex: Female

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

Dermabond

Study Details

Brief summary:

A Comparison of Skin Closure Techniques after Primary Cesarean Delivery. Traci N. Gray, M.D. and Peter F. Schnatz, D.O.

A prospective, observer blinded, randomized, and controlled trial comparing Dermabond closure technique to suture closure of skin.

Study Participants: All women age 18years or older who provide informed consent prior to primary Cesarean delivery at Hartford Hospital. Women with vertical skin incisions and or who are febrile preop or intraop will be excluded.

Methods: Qualified participants will then be randomized to skin closure with either Dermabond or suture. Surgeon preference will dictate usage of 4-0 monocryl or 4-0 vicryl for skin closure for patients randomized to the suture arm.

  • The circulating nurse will time all skin closures.
  • The surgeon will complete a 3 question survey immediately postop.
  • At the 6 week post partum visit, patients and the health care professional will complete a brief query regarding cosmetic appeal and pain. A disposable camera will be supplied to each provider office and a photo will be taken of the incision.
  • All photos will be evaluated for cosmesis by physicians who will be blinded to the methods of skin closure.

Primary Outcomes: To compare the time needed to close skin. To compare cosmetic outcome after healing

Secondary Outcomes: Patient Pain scores. Provider and patient satisfaction. Responses to questions.

Conditions

Wounds, Closure

Study ID

NCT00282633

Start date

Nov, 2005

Status verified date

Oct, 2007

Completion date

Dec, 2008

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 60

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Patients undergoing a primary Cesarean Delivery
  • Eighteen years of age or older

Exclusion Criteria:

  • Allergy to Dermabond
  • Fever pre or intra operatively
  • The need for a vertical skin incision

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Dermabond

Primary outcome measure

  • Time needed to close skin. [ Time Frame: undefined ]
  • Cosmetic outcome after healing [ Time Frame: undefined ]

Central Contacts and Locations

Locations

Hartford Hospital

Recruiting

Hartford, Connecticut, United States, 06102

Contacts

Traci Gray, M.D.

860-825-4623

More Information

Sponsor

Hartford Hospital

Last update posted

Oct 31, 2007

Last verified

Oct, 2007

Keywords

  • Cesarean Delivery
  • Wound closure
  • Suture
  • Alternative therapy
  • Surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hartford Hospital on 2007-10-31.