Effect of Skin Closure Techniques on Body Image in Women Undergoing Gynecologic Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age17-60
SponsorBaşakşehir Çam & Sakura City Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
History of prior radiotherapy to the abdominal or pelvic region.
Patients currently receiving chronic immunosuppressive therapy.
Body Mass Index (BMI) less than 18 kg/m² or greater than 40 kg/m².
Presence of cognitive impairment, dementia, or Alzheimer's disease.
Trial design
Design model
Parallel
Treatments tested in this trial
Continuous Subcuticular Suture
Procedure/SurgerySurgical skin closure performed using a continuous technique with absorbable suture material.
Interrupted Skin Closure
Procedure/SurgerySurgical skin closure performed using interrupted techniques, specifically metal staples or interrupted mattress sutures.
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Subcuticular Suture GroupExperimental treatment 1 intervention
Group B: Interrupted Closure GroupActive comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline (pre-operative), Post-operative Month 1, Post-operative Month 3 and Post-operative Month 6.Secondary outcomes
1
Incidence of Wound Complications
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.
Time frame
Post-operative Month 1, Month 3 and Month 62
Change from Baseline in Hospital Anxiety and Depression Scale (HADS) Score
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).
Time frame
Baseline (Pre-operative), Post-operative Month 1, Month 3 and Month 6.Sponsors and contacts
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Source ClinicalTrials.gov