Wound ComplicationSCDRAIN-GONCT07735962
Prophylactic Subcutaneous Drainage After Gynecologic Oncology Midline Laparotomy
A study testing Prophylactic subcutaneous closed-suction drainage and Standard closure without subcutaneous drainage in people with Wound Complication and Surgical Site Infection (SSI), run by Mahmut Yassa at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to learn whether placing a small drain under the skin can help prevent wound problems after gynecologic oncology surgery in adult women with a thick layer of tissue under the skin. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Wound Complication, Surgical Site Infection (SSI), Gynecologic Cancers
- What is being tested?
- Prophylactic subcutaneous closed-suction drainage and Standard closure without subcutaneous drainage
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 334 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jul 2026to 1 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female participants aged 18 years or older
- Undergoing midline laparotomy for gynecologic oncology surgery
- Intraoperative subcutaneous tissue thickness of 2.5 cm or greater, measured at the thickest part of the incision
- Able and willing to provide written informed consent before surgery
Who cannot join
- Emergency surgery
- Active infection before surgery
- Severe immunosuppression
- Refusal to provide written informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Başakşehir Çam and Sakura City Hospital
Istanbul
mahmut yassa, +905396635484, mahmut_yassa@hotmail.com
About this study
Official title: Effect of Prophylactic Subcutaneous Drainage on Wound Complications in Patients With Thick Subcutaneous Tissue Undergoing Midline Laparotomy for Gynecologic Oncology Surgery: A Randomized Controlled Trial
The goal of this clinical trial is to learn whether placing a small drain under the skin can help prevent wound problems after gynecologic oncology surgery in adult women with a thick layer of tissue under the skin.
The main question it aims to answer is:
Read more
Does a small drain placed under the skin lower the number of wound complications within 30 days after surgery?
Researchers will compare two groups:
Participants in one group will have a small closed-suction drain placed under the skin before the skin is closed.
Participants in the other group will not have a drain placed under the skin.
All participants will have midline abdominal surgery. During surgery, the surgeon will measure the thickness of the tissue under the skin. Participants with a thickness of 2.5 cm or more will be randomly assigned to one of the two groups.
In both groups, the tissue under the skin will be closed in a standard way using separate 2/0 Vicryl stitches. Participants in the drain group will have the drain removed when the amount of fluid collected in 24 hours is less than 30 mL, unless the surgeon decides that earlier or later removal is needed.
Participants will be followed for 30 days after surgery to check for wound problems such as infection, wound separation, fluid collection, blood collection, or the need for extra wound care or another procedure.
Read the detailed description
Wound complications after gynecologic oncology surgery are clinically important because they may increase postoperative morbidity, delay recovery, prolong hospital stay, and postpone planned adjuvant treatment. Increased subcutaneous tissue thickness is a recognized surgical risk factor for wound-related problems after abdominal surgery. However, the benefit of routinely placing a prophylactic drain in the subcutaneous tissue remains uncertain, and practice varies among surgeons.
This study will evaluate a standardized approach to prophylactic subcutaneous drainage in participants undergoing gynecologic oncology surgery through a midline laparotomy. The study is designed as a single-center, prospective, randomized, open-label, parallel-group clinical trial. Because the intervention is a surgical procedure that is visible to the operating team and to postoperative care providers, masking will not be used.
Written informed consent will be obtained before surgery from potentially eligible participants. The final eligibility for randomization will be confirmed during surgery by measuring the subcutaneous tissue thickness with a sterile ruler at the thickest part of the incision. Participants who meet the intraoperative thickness requirement will be assigned to one of the study groups using a pre-generated randomization sequence and sequentially numbered, opaque, sealed envelopes.
The study compares two standard surgical approaches used in routine clinical practice: placement of a closed-suction drain in the subcutaneous tissue versus no subcutaneous drain. No investigational drug, biological product, or experimental medical device will be used. In both groups, subcutaneous tissue approximation will be standardized with interrupted 2/0 Vicryl sutures. In the drainage group, the subcutaneous drain will be managed according to a predefined removal criterion based on the 24-hour drainage volume, unless clinical circumstances require a different decision.
Postoperative care will otherwise follow the usual clinical practice of the gynecologic oncology surgery service. Wound-related findings and postoperative clinical data will be collected during hospitalization, at discharge, and during the postoperative follow-up period. Hospital records, outpatient assessments, readmission records, and telephone follow-up may be used to complete follow-up information when needed.
The primary analysis will follow the intention-to-treat principle, with participants analyzed according to their randomized group. A supportive per-protocol analysis will also be performed to assess the effect of protocol adherence. The main treatment effect will be expressed using absolute risk difference with 95% confidence intervals, with relative effect estimates reported as additional measures. The results are expected to clarify whether routine prophylactic subcutaneous drainage provides clinically meaningful benefit in patients with thick subcutaneous tissue undergoing gynecologic oncology midline laparotomy.
Prespecified exploratory analyses will examine the association between baseline and intraoperative variables (body mass index, diabetes mellitus, preoperative hemoglobin, preoperative serum albumin, operative duration, bowel intervention, and subcutaneous tissue thickness) and 30-day composite wound complication using multivariable logistic regression. These analyses are exploratory and are not registered as outcome measures.
- Being tested
- Prophylactic subcutaneous closed-suction drainage, Standard closure without subcutaneous drainage
- Keywords
- subcutaneous drain, gynecologic oncology, midline laparotomy, wound complication, surgical site infection, subcutaneous tissue thickness, randomized controlled trial
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic subcutaneous closed-suction drainageProcedure or surgery
Placement of a closed-suction drain in the subcutaneous tissue before skin closure in patients with intraoperative subcutaneous tissue thickness of 2.5 cm or greater.
Standard closure without subcutaneous drainageProcedure or surgery
Standardized subcutaneous tissue approximation and skin closure without placement of a prophylactic subcutaneous drain.
| Study group | Role | What they receive |
|---|---|---|
| Subcutaneous Drain | Experimental | Participants allocated to this arm will receive prophylactic closed-suction subcutaneous drainage after midline laparotomy and before skin closure. Subcutaneous tissue approximation will be performed with interrupted 2/0 Vicryl sutures. The drain will be removed when the 24-hour drainage volume is less than 30 mL, unless earlier or later removal is clinically indicated. Receives: Procedure: Prophylactic subcutaneous closed-suction drainage |
| No Subcutaneous Drain | Active comparator | Participants allocated to this arm will undergo standard surgical closure without prophylactic subcutaneous drainage. Subcutaneous tissue approximation will be performed with interrupted 2/0 Vicryl sutures. Receives: Procedure: Standard closure without subcutaneous drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite wound complication within 30 postoperative days
The primary outcome is the incidence of composite wound complication within 30 postoperative days. Composite wound complication is defined as the occurrence of at least one of the following: surgical site infection, wound dehiscence, clinically significant subcutaneous seroma, clinically significant subcutaneous hematoma, or wound-related intervention.
Clinically significant subcutaneous seroma or hematoma is defined as a seroma or hematoma requiring any additional wound care beyond routine postoperative care, unscheduled clinical assessment, imaging, antibiotic treatment, aspiration, drainage, readmission, or surgical intervention.
Wound-related intervention is defined as any wound-directed procedure (aspiration, drainage, re-suturing, surgical revision, or operative wound debridement) performed because of a postoperative wound complication, in either an inpatient or outpatient setting.
Measured: Up to 30 days after surgery
Secondary outcomes (8)
Surgical site infection within 30 postoperative days
Incidence of surgical site infection within 30 postoperative days, including superficial or deep incisional surgical site infection as clinically diagnosed and recorded during postoperative follow-up.
Measured: Up to 30 days after surgery
Wound dehiscence within 30 postoperative days
Incidence of wound dehiscence within 30 postoperative days, including superficial or deep wound separation documented during postoperative follow-up.
Measured: Up to 30 days after surgery
Clinically significant subcutaneous seroma within 30 postoperative days
Incidence of clinically significant subcutaneous seroma within 30 postoperative days. Clinically significant seroma is defined as a seroma requiring additional wound care beyond routine postoperative care, unscheduled clinical assessment, imaging, antibiotic treatment, aspiration, drainage, readmission, or surgical intervention.
Measured: Up to 30 days after surgery
Clinically significant subcutaneous hematoma within 30 postoperative days
Incidence of clinically significant subcutaneous hematoma within 30 postoperative days. Clinically significant hematoma is defined as a hematoma requiring additional wound care beyond routine postoperative care, unscheduled clinical assessment, imaging, antibiotic treatment, aspiration, drainage, readmission, or surgical intervention.
Measured: Up to 30 days after surgery
Wound-related intervention within 30 postoperative days
Incidence of wound-related intervention within 30 postoperative days. Wound-related intervention is defined as any wound-directed procedure performed because of a postoperative wound complication, including aspiration, drainage, re-suturing, surgical revision, or operative wound debridement, regardless of whether the procedure is performed in an inpatient or outpatient setting.
Measured: Up to 30 days after surgery
Wound-related readmission within 30 postoperative days
Incidence of hospital readmission within 30 postoperative days due to a wound-related complication.
Measured: Up to 30 days after surgery
Postoperative length of hospital stay
Length of postoperative hospital stay, defined as the number of days from surgery to hospital discharge.
Measured: From the date of surgery to hospital discharge, assessed up to 30 days after surgery
Subcutaneous tissue thickness in participants with and without 30-day composite wound complication
Subcutaneous tissue thickness, measured in centimeters intraoperatively with a sterile ruler at the thickest part of the midline incision, reported separately for participants with and without composite wound complication within 30 postoperative days.
Measured: Up to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start20 Jul 2026
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants who provide written informed consent before surgery will undergo intraoperative measurement of subcutaneous tissue thickness. Participants with subcutaneous tissue thickness of 2.5 cm or greater will be randomized in a 1:1 ratio to one of two parallel groups: prophylactic subcutaneous drainage or no subcutaneous drainage. Randomization will be performed using a pre-generated block randomization sequence with sequentially numbered, opaque, sealed envelopes.
- Masking
- None (open label)
- Enrolment
- 334 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahmut Yassa
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Mahmut Yassa, Başakşehir Çam & Sakura City Hospital
- Investigators
- MAHMUT YASSA, MD, Principal investigator, Başakşehir Çam & Sakura City HospitalBora Taşpınar, MD, Study director, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07735962
- Sponsor's protocol ID
- SCDRAIN-GO-RCT-2026
- Acronym
- SCDRAIN-GO
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the published results, together with a data dictionary, will be made available upon reasonable request to the corresponding investigator. Data will be shared only after publication of the primary study results and subject to institutional approval, a scientifically sound research proposal, and execution of a data use agreement. Additional data may be considered on a case-by-case basis at the discretion of the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prophylactic Subcutaneous Drainage on Wound Complications in Patients With Thick Subcutaneous Tissue Undergoing Midline Laparotomy for Gynecologic Oncology Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07735962
- Acronym / sponsor ID
- SCDRAIN-GO / SCDRAIN-GO-RCT-2026
- Keywords
- subcutaneous drain, gynecologic oncology, midline laparotomy, wound complication, surgical site infection, subcutaneous tissue thickness, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 334 participants (estimated)
- Lead sponsor
- Mahmut YassaOther government
- Study start
- 20 Jul 2026 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn whether placing a small drain under the skin can help prevent wound problems after gynecologic oncology surgery in adult women with a thick layer of tissue under the skin.
The main question it aims to answer is:
Does a small drain placed under the skin lower the number of wound complications within 30 days after surgery?
Researchers will compare two groups:
Participants in one group will have a small closed-suction drain placed under the skin before the skin is closed.
Participants in the other group will not have a drain placed under the skin.
All participants will have midline abdominal surgery. During surgery, the surgeon will measure the thickness of the tissue under the skin. Participants with a thickness of 2.5 cm or more will be randomly assigned to one of the two groups.
In both groups, the tissue under the skin will be closed in a standard way using separate 2/0 Vicryl stitches. Participants in the drain group will have the drain removed when the amount of fluid collected in 24 hours is less than 30 mL, unless the surgeon decides that earlier or later removal is needed.
Participants will be followed for 30 days after surgery to check for wound problems such as infection, wound separation, fluid collection, blood collection, or the need for extra wound care or another procedure.
Detailed description
Wound complications after gynecologic oncology surgery are clinically important because they may increase postoperative morbidity, delay recovery, prolong hospital stay, and postpone planned adjuvant treatment. Increased subcutaneous tissue thickness is a recognized surgical risk factor for wound-related problems after abdominal surgery. However, the benefit of routinely placing a prophylactic drain in the subcutaneous tissue remains uncertain, and practice varies among surgeons.
This study will evaluate a standardized approach to prophylactic subcutaneous drainage in participants undergoing gynecologic oncology surgery through a midline laparotomy. The study is designed as a single-center, prospective, randomized, open-label, parallel-group clinical trial. Because the intervention is a surgical procedure that is visible to the operating team and to postoperative care providers, masking will not be used.
Written informed consent will be obtained before surgery from potentially eligible participants. The final eligibility for randomization will be confirmed during surgery by measuring the subcutaneous tissue thickness with a sterile ruler at the thickest part of the incision. Participants who meet the intraoperative thickness requirement will be assigned to one of the study groups using a pre-generated randomization sequence and sequentially numbered, opaque, sealed envelopes.
The study compares two standard surgical approaches used in routine clinical practice: placement of a closed-suction drain in the subcutaneous tissue versus no subcutaneous drain. No investigational drug, biological product, or experimental medical device will be used. In both groups, subcutaneous tissue approximation will be standardized with interrupted 2/0 Vicryl sutures. In the drainage group, the subcutaneous drain will be managed according to a predefined removal criterion based on the 24-hour drainage volume, unless clinical circumstances require a different decision.
Postoperative care will otherwise follow the usual clinical practice of the gynecologic oncology surgery service. Wound-related findings and postoperative clinical data will be collected during hospitalization, at discharge, and during the postoperative follow-up period. Hospital records, outpatient assessments, readmission records, and telephone follow-up may be used to complete follow-up information when needed.
The primary analysis will follow the intention-to-treat principle, with participants analyzed according to their randomized group. A supportive per-protocol analysis will also be performed to assess the effect of protocol adherence. The main treatment effect will be expressed using absolute risk difference with 95% confidence intervals, with relative effect estimates reported as additional measures. The results are expected to clarify whether routine prophylactic subcutaneous drainage provides clinically meaningful benefit in patients with thick subcutaneous tissue undergoing gynecologic oncology midline laparotomy.
Prespecified exploratory analyses will examine the association between baseline and intraoperative variables (body mass index, diabetes mellitus, preoperative hemoglobin, preoperative serum albumin, operative duration, bowel intervention, and subcutaneous tissue thickness) and 30-day composite wound complication using multivariable logistic regression. These analyses are exploratory and are not registered as outcome measures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants who provide written informed consent before surgery will undergo intraoperative measurement of subcutaneous tissue thickness. Participants with subcutaneous tissue thickness of 2.5 cm or greater will be randomized in a 1:1 ratio to one of two parallel groups: prophylactic subcutaneous drainage or no subcutaneous drainage. Randomization will be performed using a pre-generated block randomization sequence with sequentially numbered, opaque, sealed envelopes.
| Arm | Type | Receives |
|---|---|---|
| Subcutaneous Drain | Experimental | Procedure: Prophylactic subcutaneous closed-suction drainageParticipants allocated to this arm will receive prophylactic closed-suction subcutaneous drainage after midline laparotomy and before skin closure. Subcutaneous tissue approximation will be performed with interrupted 2/0 Vicryl sutures. The drain will be removed when the 24-hour drainage volume is less than 30 mL, unless earlier or later removal is clinically indicated. |
| No Subcutaneous Drain | Active comparator | Procedure: Standard closure without subcutaneous drainageParticipants allocated to this arm will undergo standard surgical closure without prophylactic subcutaneous drainage. Subcutaneous tissue approximation will be performed with interrupted 2/0 Vicryl sutures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female participants aged 18 years or older
- Undergoing midline laparotomy for gynecologic oncology surgery
- Intraoperative subcutaneous tissue thickness of 2.5 cm or greater, measured at the thickest part of the incision
- Able and willing to provide written informed consent before surgery
Key exclusion criteria (4 listed)
- Emergency surgery
- Active infection before surgery
- Severe immunosuppression
- Refusal to provide written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prophylactic subcutaneous closed-suction drainagePlacement of a closed-suction drain in the subcutaneous tissue before skin closure in patients with intraoperative subcutaneous tissue thickness of 2.5 cm or greater. | Procedure or surgery | Subcutaneous Drain |
| Standard closure without subcutaneous drainageStandardized subcutaneous tissue approximation and skin closure without placement of a prophylactic subcutaneous drain. | Procedure or surgery | No Subcutaneous Drain |
Primary outcome
Composite wound complication within 30 postoperative days
Time frame: Up to 30 days after surgery
The primary outcome is the incidence of composite wound complication within 30 postoperative days. Composite wound complication is defined as the occurrence of at least one of the following: surgical site infection, wound dehiscence, clinically significant subcutaneous seroma, clinically significant subcutaneous hematoma, or wound-related intervention. Clinically significant subcutaneous seroma or hematoma is defined as a seroma or hematoma requiring any additional wound care beyond routine postoperative care, unscheduled clinical assessment, imaging, antibiotic treatment, aspiration, drainage, readmission, or surgical intervention. Wound-related intervention is defined as any wound-directed procedure (aspiration, drainage, re-suturing, surgical revision, or operative wound debridement) performed because of a postoperative wound complication, in either an inpatient or outpatient setting.
8 secondary outcomes
Surgical site infection within 30 postoperative days
Time frame: Up to 30 days after surgery
Wound dehiscence within 30 postoperative days
Time frame: Up to 30 days after surgery
Clinically significant subcutaneous seroma within 30 postoperative days
Time frame: Up to 30 days after surgery
Clinically significant subcutaneous hematoma within 30 postoperative days
Time frame: Up to 30 days after surgery
Wound-related intervention within 30 postoperative days
Time frame: Up to 30 days after surgery
Wound-related readmission within 30 postoperative days
Time frame: Up to 30 days after surgery
Postoperative length of hospital stay
Time frame: From the date of surgery to hospital discharge, assessed up to 30 days after surgery
Subcutaneous tissue thickness in participants with and without 30-day composite wound complication
Time frame: Up to 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the published results, together with a data dictionary, will be made available upon reasonable request to the corresponding investigator. Data will be shared only after publication of the primary study results and subject to institutional approval, a scientifically sound research proposal, and execution of a data use agreement. Additional data may be considered on a case-by-case basis at the discretion of the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
MAHMUT YASSA, MD principal investigator
Başakşehir Çam & Sakura City Hospital
Bora Taşpınar, MD study director
Başakşehir Çam & Sakura City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prophylactic subcutaneous closed-suction drainage and Standard closure without subcutaneous drainage in people with Wound Complication and Surgical Site Infection (SSI), run by Mahmut Yassa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MAHMUT yassa, MD (+905396635484, mahmut_yassa@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite wound complication within 30 postoperative days (time frame: Up to 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.