Effect of Skin Closure Techniques on Body Image in Women Undergoing Gynecologic Surgery (BISGO)

Başakşehir Çam & Sakura City Hospital

Status: Not yet enrolling

Conditions: Body Image; Gynecologic Cancers; Surgical Wound Closure Techniques

Treatments: Procedure: Continuous Subcuticular Suture; Procedure: Interrupted Skin Closure

Study type: Interventional

Funder types: Other

Identifiers

NCT07327125

BCSSH-JINONK-01

Details and patient eligibility

About

This randomized clinical trial investigates the impact of two different skin closure techniques on body image and mood in women undergoing surgery for gynecologic cancers.

Patients undergoing elective surgery with a midline abdominal incision will be randomly assigned to one of two groups: 1. Interrupted Closure Group: The surgical incision is closed using either metal clips (staples) or separate mattress sutures (individual stitches). 2. Subcuticular Sutures Group: The surgical incision is closed using continuous stitches placed under the skin surface (aesthetic stitching).

The main goal of the study is to determine whether the method of wound closure affects a patient's perception of their body image, cosmetic satisfaction, and levels of anxiety or depression.

Additionally, the study aims to prove that the subcuticular suture technique is safe and does not increase the risk of wound complications (such as infection or wound separation) compared to the other method.

Participants will be asked to complete questionnaires before surgery, and again at 1, 3 and 6 months after surgery to track changes in their feelings and satisfaction with the scar.

Full description

Midline abdominal incisions are common in gynecologic oncology, yet the optimal skin closure technique to minimize scar-related psychological distress remains unclear. While staples offer speed, subcuticular sutures may provide superior cosmetic results. This study aims to fill the gap in the literature regarding the specific impact of these closure methods on body image and patient-reported outcomes in gynecologic cancer patients, beyond standard wound complication rates.

Enrollment: 140 estimated patients

Sex: Female

Ages: 17 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female participants aged 18 years or older.
• Patients scheduled for elective open gynecologic surgery for suspected or confirmed gynecologic malignancy.
• Surgery planned to be performed via a vertical midline laparotomy incision.
• Literate patients capable of reading, understanding, and completing the Body Image Scale (BIS) and Hospital Anxiety and Depression Scale (HADS).
• Patients who provide written informed consent to participate in the study.

Exclusion criteria

• History of prior radiotherapy to the abdominal or pelvic region.
• Patients currently receiving chronic immunosuppressive therapy.
• Body Mass Index (BMI) less than 18 kg/m^2 or greater than 40 kg/m^2.
• Presence of cognitive impairment, dementia, or Alzheimer's disease.
• Major psychiatric disorders that prevent the patient from understanding or completing the questionnaires.
• Patients undergoing emergency surgery.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Subcuticular Suture Group

Experimental group

Description:

Patients in this group will undergo skin closure using a continuous subcuticular suture technique with absorbable suture material.

Treatment:

Procedure: Continuous Subcuticular Suture

Interrupted Closure Group

Active Comparator group

Description:

Patients in this group will undergo skin closure using interrupted techniques. The incision will be closed with either surgical staples (metal clips) or interrupted mattress sutures, depending on the standard practice.

Treatment:

Procedure: Interrupted Skin Closure