An interventional study of Continuous Subcuticular Suture and Interrupted Skin Closure in Gynecologic Cancers, Surgical Wound Closure Techniques and Body Image, sponsored by Başakşehir Çam & Sakura City Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 17 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-04-14.
Sponsored by Başakşehir Çam & Sakura City Hospital · Not applicable, Interventional, and Treatment
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.
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.
315 studies on the registry are indexed under Surgical Wound; 57 are open to participants now.
This study's planned enrollment of 140 is above the median of 66 across 242 interventional studies indexed under Surgical Wound.
Browse Surgical Wound studies →Başakşehir Çam & Sakura City Hospital is the lead sponsor of 109 studies on the registry; 36 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in this group will undergo skin closure using a continuous subcuticular suture technique with absorbable suture material.
Procedure: Continuous Subcuticular Suture
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
Surgical skin closure performed using a continuous technique with absorbable suture material.
Surgical skin closure performed using interrupted techniques, specifically metal staples or interrupted mattress sutures.
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.
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 6
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.
Plan to share: Yes — De-identified individual participant data (IPD) that underlie the results reported in the article (text, tables, and figures) will be shared. This includes the data on body image scores, anxiety/depression scores, and wound complications. Data will be available beginning 6 months and ending 5 years following article publication to researchers who provide a methodologically sound proposal. Proposals should be directed to the Principal Investigator. To gain access, data requestors will need to sign a data access agreement.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
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.
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