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

NCT07327125 | Recruiting DMC

• 1 other identifier: BCSSH-JINONK-01
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gynecologic Cancers; Body Image; Surgical Wound Closure Techniques

Keywords

surgical staples; Subcuticular Sutures; Gynecologic Oncology; Skin Closure Techniques; Body Image; Surgical Wound; Laparotomy; Cicatrix; Anxiety; Depression; Midline Incision; Wound Dehiscence; Wound Complications; Surgical Site Infection

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Body Image Scale (BIS) Score

  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.

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

Secondary Outcomes (2)

• Incidence of Wound Complications

  Post-operative Month 1, Month 3 and Month 6

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

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

Study Arms (2)

Subcuticular Suture Group

EXPERIMENTAL

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

Procedure: Continuous Subcuticular Suture

Interrupted Closure Group

ACTIVE COMPARATOR

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.

Procedure: Interrupted Skin Closure

Interventions

Continuous Subcuticular Suture PROCEDURE

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

Subcuticular Suture Group

Interrupted Skin Closure PROCEDURE

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

Interrupted Closure Group

Eligibility Criteria

• Age: 17 Years - 60 Years
• Gender Eligibility Details: Women
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead

Study Sites (1)

Başakşehir Çam and Sakura City Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Surgical Wound; Cicatrix; Anxiety Disorders; Depression; Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wounds and Injuries; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior; Wound Infection; Infections; Postoperative Complications

Study Officials

• Bora Taşpınar, MD

  Başakşehir Çam & Sakura City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

mahmut yassa, MD

CONTACT

+90 539 663 54 84; mahmut_yassa@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator - Gynecologic Oncology Specialist

Model Details: This is a prospective, randomized, parallel-group study. Participants are stratified based on Body Mass Index (\<30 vs. ≥30 kg/m²), incision length (\<15 cm vs. ≥15 cm), and intra-operative frozen section pathology result (Benign vs. Malignant). Randomization is performed intra-operatively, immediately after the frozen section result is available. Allocation uses a 1:1 ratio with permuted blocks of variable sizes (4, 6, 8) to ensure balanced assignment within each stratum. The randomization sequence was pre-generated using a fixed random seed (offline Excel file). Allocation concealment is maintained; the operating surgeon is blinded to future assignments and accesses the next allocation only after the patient is fully eligible.

Study Record Dates

• First Submitted: December 25, 2025
• First Posted: January 8, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 6 months and ending 5 years following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal approved by an independent review committee or the Principal Investigator. Data will be shared for the purpose of achieving the aims in the approved proposal.

Locations

TU (1)