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NCT Number: NCT07327125

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

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.

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Key information

Conditions

Gynecologic Cancers Anxiety Disorders Behavior Behavioral Symptoms Body Image Cicatrix Depression Fibrosis Infections Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Surgical Wound Closure Techniques Surgical Wound Infection Wound Infection Wounds and Injuries

Age range

17 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Başakşehir Çam and Sakura City Hospital

Istanbul, Turkey (Türkiye)

Location status: Recruiting

Location contact

mahmut yassa

CONTACT

[email protected]

+905396635484

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Continuous Subcuticular Suture

Procedure

Surgical skin closure performed using a continuous technique with absorbable suture material.

Interrupted Skin Closure

Procedure

Surgical skin closure performed using interrupted techniques, specifically metal staples or interrupted mattress sutures.

Primary outcomes

  1. Change from Baseline in Body Image Scale (BIS) Score

    Time frame: Baseline (pre-operative), Post-operative Month 1, Post-operative Month 3 and Post-operative Month 6.

    The Body Image Scale (BIS) is a 10-item questionnaire designed to assess body image changes in cancer patients. Each item is scored on a 4-point Likert scale ranging from 0 (not at all) to 3 (very much). The total score ranges from 0 to 30. Higher scores indicate higher levels of body image distress and dissatisfaction.

Secondary outcomes

  1. Incidence of Wound Complications

    Time frame: Post-operative Month 1, Month 3 and Month 6

    Evaluation of surgical site complications including superficial or deep surgical site infection (SSI), wound dehiscence (separation of wound edges), seroma, and hematoma. Diagnosis is based on clinical examination and standard CDC criteria.

  2. Change from Baseline in Hospital Anxiety and Depression Scale (HADS) Score

    Time frame: Baseline (Pre-operative), Post-operative Month 1, Month 3 and Month 6.

    The HADS is a 14-item self-report screening scale. It consists of two subscales: Anxiety (HADS-A, 7 items) and Depression (HADS-D, 7 items). Each item is scored from 0 to 3. The maximum score for each subscale is 21. Higher scores indicate higher levels of anxiety or depression (worse outcome).

Study contacts

Contact information is provided by the study sponsor or research team.

mahmut yassa, MD

CONTACT

[email protected]

+90 539 663 54 84

Sponsors and collaborators

Lead sponsor

Başakşehir Çam & Sakura City Hospital

Other Gov

Registry information

Official study title

Effect of Skin Closure Techniques on Body Image and Mood in Gynecologic Oncology Patients

Acronym: BISGO

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 8, 2026
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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