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Prophylactic Subcutaneous Drainage After Gynecologic Oncology Midline Laparotomy (SCDRAIN-GO)

29 juli 2026 bijgewerkt door: Mahmut Yassa

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:

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

334

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Emergency surgery
  • Active infection before surgery
  • Severe immunosuppression
  • Refusal to provide written informed consent

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Subcutaneous Drain
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.
Procedure: Prophylactic subcutaneous closed-suction drainage
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.
Actieve vergelijker: No Subcutaneous Drain
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.
Procedure: Standard closure without subcutaneous drainage
Standardized subcutaneous tissue approximation and skin closure without placement of a prophylactic subcutaneous drain.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Composite wound complication within 30 postoperative days
Tijdsspanne: 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.
Up to 30 days after surgery

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Surgical site infection within 30 postoperative days
Tijdsspanne: Up to 30 days after surgery
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.
Up to 30 days after surgery
Wound dehiscence within 30 postoperative days
Tijdsspanne: Up to 30 days after surgery
Incidence of wound dehiscence within 30 postoperative days, including superficial or deep wound separation documented during postoperative follow-up.
Up to 30 days after surgery
Clinically significant subcutaneous seroma within 30 postoperative days
Tijdsspanne: Up to 30 days after surgery
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.
Up to 30 days after surgery
Clinically significant subcutaneous hematoma within 30 postoperative days
Tijdsspanne: Up to 30 days after surgery
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.
Up to 30 days after surgery
Wound-related intervention within 30 postoperative days
Tijdsspanne: Up to 30 days after surgery
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.
Up to 30 days after surgery
Wound-related readmission within 30 postoperative days
Tijdsspanne: Up to 30 days after surgery
Incidence of hospital readmission within 30 postoperative days due to a wound-related complication.
Up to 30 days after surgery
Postoperative length of hospital stay
Tijdsspanne: From the date of surgery to hospital discharge, assessed up to 30 days after surgery
Length of postoperative hospital stay, defined as the number of days from surgery to hospital discharge.
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
Tijdsspanne: Up to 30 days after surgery
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.
Up to 30 days after surgery

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Mahmut Yassa

Onderzoekers

  • Hoofdonderzoeker: MAHMUT YASSA, MD, Başakşehir Çam & Sakura City Hospital
  • Studie directeur: Bora Taşpınar, MD, Başakşehir Çam & Sakura City Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

20 juli 2026

Primaire voltooiing (Geschat)

1 januari 2028

Studie voltooiing (Geschat)

1 maart 2028

Studieregistratiedata

Eerst ingediend

16 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

29 juli 2026

Eerst geplaatst (Werkelijk)

30 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

30 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

29 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • SCDRAIN-GO-RCT-2026

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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.

IPD-tijdsbestek voor delen

Beginning 6 months after publication of the primary study results and ending 3 years after publication.

IPD-toegangscriteria voor delen

Access will be considered for qualified researchers conducting scientifically sound research. Requests must include a research proposal and, where appropriate, a statistical analysis plan. All requests will be reviewed by the principal investigator and approved according to institutional policies. Approved researchers will be required to sign a data use agreement before receiving de-identified data.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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