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Gastrointestinal TumorsDressingNCT06263205

Non-Dressing vs. Routine Dressing Change After Gastrointestinal Cancer Surgery

A study testing Non-Dressing of Surgical Wound and Regular Dressing Change of Surgical Wound in people with Gastrointestinal Tumors and Surgical Wound Infection, run by Fudan University at 4 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this randomized non-inferiority trial is to evaluate whether omitting postoperative wound dressings is noninferior to routine dressing changes in patients undergoing gastrointestinal cancer surgery. The main questions it aims to answer are: 1. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Non-Dressing of Surgical Wound and Regular Dressing Change of Surgical Wound
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,138 participants
Where
4 sitesChina
Study dates
1 Apr 2024to 30 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged between 18 and 75 years.
  • Having undergone elective gastrointestinal surgery for gastrointestinal cancer (histologically confirmed) within the past 24 hours.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  • Possessing sufficient cognitive ability to understand the study protocol and voluntarily signing a written informed consent form.

Who cannot join

  • Presence of significant barriers to completing postoperative follow-up (e.g., severe sensory/cognitive impairment, inability to adhere to follow-up plan, lack of reliable contact methods, residence >6 hours from study center).
  • Concurrent active skin diseases that may affect wound healing (e.g., psoriasis, chronic eczema, atopic dermatitis) located at or near the surgical incision site.
  • History of major abdominal trauma or prior abdominal surgery resulting in abdominal wall deformity or extensive scarring that may affect incision healing or assessment.
  • Current diagnosis of any other uncontrolled severe comorbid conditions (e.g., uncontrolled other malignant tumors, acute or persistent chronic infections) that may pose additional risks or confound study outcomes.
  • Planned or ongoing receipt of any other anticancer treatments (chemotherapy, targeted therapy, biological therapy, radiotherapy) or long-term immunosuppressive therapy during the perioperative period.
  • Current long-term or high-dose use of systemic corticosteroids or any other medications that may significantly affect wound healing (topical/inhaled/low-dose steroids allowed if assessed by investigator).

Trial locations and contacts

4 sites in 1 country.

China4 sites

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 2000000

  • Changzheng Hospital, Navy Medical University

    Shanghai, Shanghai Municipality, 200003

  • Shanghai East Hospital, School of Medicine, Tongji University

    Shanghai, Shanghai Municipality, 200120

  • Changhai Hospital, Naval Medical University

    Shanghai, Shanghai Municipality, 200433

Other trials in China

About this study

Official title: A Randomized, Open-Label, Multicenter, Non-Inferiority Clinical Trial Comparing No Wound Dressing Change Versus Routine Wound Dressing Change After Gastrointestinal Surgery

The goal of this randomized non-inferiority trial is to evaluate whether omitting postoperative wound dressings is noninferior to routine dressing changes in patients undergoing gastrointestinal cancer surgery. The main questions it aims to answer are:

  1. Is omitting dressings noninferior to routine dressing changes in preventing a composite of wound complications requiring clinical intervention?
  2. Can omitting dressings reduce postoperative pain and eliminate dressing-related costs?
Read more

Participants diagnosed with gastrointestinal tumors undergoing elective surgery will be randomly assigned to either the non-dressing group or the routine dressing group. The non-dressing group will have their initial dressing removed at 48 hours postoperatively, with no further coverage or disinfection unless clinically indicated. The dressing group will receive standardized dressing changes every 48 hours until suture removal at 7-14 days. Researchers will compare the two groups regarding the rate of wound complications, pain scores, and total dressing-related costs.

This study aims to provide evidence-based recommendations for minimalist postoperative wound care, potentially improving patient comfort and reducing unnecessary medical expenses.

Read the detailed description

Research Objectives and Design:

This study is a prospective, multicenter, randomized, open-label, parallel-group, non-inferiority trial. The primary objective is to demonstrate that omitting routine dressing changes is noninferior to standard care for preventing a composite of wound complications within 30 days after gastrointestinal cancer surgery. Secondary objectives are to compare postoperative pain scores and total dressing-related costs between the two strategies.

Inclusion Criteria and Sample Size:

A total of 1138 patients aged 18 to 75 years who underwent elective gastrointestinal surgery for histologically confirmed malignancies were enrolled and randomized. Key inclusion criteria included an ECOG Performance Status of 0 or 1. Key exclusion criteria included active skin disorders at the incision site, uncontrolled comorbidities, prior abdominal radiotherapy, recent immunosuppressive therapy, or inability to complete follow-up, as detailed in the protocol.

Study Methodology:

Participants were randomly assigned in a 1:1 ratio to either the non-dressing group or the routine dressing group. In the non-dressing group, the initial dressing was removed 48 hours postoperatively, with no further disinfection, cleansing, or wound coverage unless specific clinical indications arose (e.g., purulent discharge, extensive erythema). In the routine dressing group, patients received standardized dressing changes every 48 hours, consisting of disinfection with 10% povidone-iodine and application of a new sterile dressing, until suture removal at 7-14 days postoperatively. All wound complications were adjudicated by an independent, blinded Endpoint Committee using standardized photographic evidence.

Follow-up and Outcomes:

Follow-up assessments were conducted every other day before discharge and at postoperative days 14 and 30. The primary outcome was the composite incidence of postoperative wound complications requiring clinical intervention within 30 days after surgery (incisional SSI, fat liquefaction, hematoma or seroma, wound dehiscence, or delayed healing). Secondary outcomes included individual complication rates, pain scores measured by Visual Analog Scale (VAS, 0-10) on postoperative days 2, 4, and 6, and total dressing-related costs.

Statistical Analysis:

The primary analysis was performed on the intention-to-treat population. Non-inferiority was concluded if the upper bound of the two-sided 95% confidence interval for the risk difference (non-dressing minus dressing) was below the prespecified margin of +6%. The non-inferiority hypothesis was tested with a one-sided alpha of 0.025.

Being tested
Non-Dressing of Surgical Wound, Regular Dressing Change of Surgical Wound
Keywords
Wound Dressing, Non-inferiority Trial, Gastrointestinal Neoplasms, Surgical Site Infection, Cost-effectiveness, Randomized Controlled Trial
Medical subject headings
Digestive System Neoplasms, Surgical Wound Infection, Pain, Postoperative, Gastrointestinal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Non-Dressing of Surgical WoundProcedure or surgery

    Participants received standard wound disinfection and initial sterile dressing immediately after surgery. At 48 hours postoperatively, the initial dressing was removed. Unless specific clinical indications arose (e.g., purulent discharge, extensive erythema), no further disinfection or wound coverage was performed. The incision remained exposed until suture removal at 7-14 days postoperatively. This intervention evaluates the noninferiority of omitting routine dressing changes in terms of wound complications, pain reduction, and cost savings.

  • Regular Dressing Change of Surgical WoundProcedure or surgery

    This intervention involves standard postoperative wound care. After surgery, wounds were disinfected and covered with dressings. Dressings were changed every 48 hours (with disinfection and reapplication) until suture removal (7-14 days postoperatively), following traditional wound management practices.

Study groups in NCT06263205
Study groupRoleWhat they receive
Non-Dressing GroupExperimentalParticipants in this group received standard wound disinfection and initial sterile dressing immediately after surgery. At 48 hours postoperatively, the initial dressing was removed. No further disinfection, cleansing, or wound coverage was performed unless specific clinical indications arose. The incision remained exposed until suture removal at 7-14 days postoperatively. This arm evaluates whether omitting routine dressing changes is noninferior to standard care in preventing wound complications.
Receives: Procedure: Non-Dressing of Surgical Wound
Dressing GroupActive comparatorParticipants in this group received standard postoperative care. Their surgical wounds were covered with dressings immediately after surgery, and these dressings were changed every 48 hours (including disinfection and reapplication of dressing) until suture removal at 7-14 days postoperatively. This group serves as the comparator for assessing the non-dressing approach.
Receives: Procedure: Regular Dressing Change of Surgical Wound

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of composite wound complications within 30 days after surgery

    This is a composite endpoint including surgical site infection, wound dehiscence, hematoma/seroma requiring intervention, fat liquefaction, and delayed wound healing, each of which necessitated additional medical intervention. The non-inferiority of the "no dressing change" strategy versus the "routine dressing change" strategy will be tested using the Farrington-Manning test. The pre-specified non-inferiority margin (Δ) is 6%. Non-inferiority will be established if the upper limit of the two-sided 95% confidence interval for the difference in incidence rates (no dressing change minus routine dressing change) is below 6%.

    Time Frame: Up to 30 days after surgery.

    Measured: Within 30 days after surgery

Secondary outcomes (2)

  1. Postoperative Pain Score

    Pain intensity measured using the Visual Analog Scale (VAS), a 0-10 scale with higher scores indicating greater pain. Assessments are performed at rest by trained research staff.

    Measured: Postoperative days 2, 4, and 6

  2. Total Dressing-Related Costs

    Direct costs calculated from the hospital perspective using standardized fee schedules. Total cost per patient includes three components: (1) material costs (primary sterile dressing), (2) nursing procedure fees for each dressing change (classified as minor, intermediate, or major according to the National Catalog of Medical Service Prices), and (3) any additional treatment costs incurred due to management of wound complications.

    Measured: From the time of surgery up to 30 days post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2024
  2. Study start1 Apr 2024
  3. Primary completion30 Jul 2025
  4. Study completion30 Jul 2025

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants were assigned in a 1:1 ratio to either the non-dressing group or the routine dressing group.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,138 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06263205
Sponsor's protocol ID
Dressing
Acronym
Dressing
Status last verified
Jun 2026
First submitted
15 Jan 2024
Last updated
22 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The IPD that will be shared includes de-identified participant data encompassing demographic information, clinical data, and study outcomes. Supporting documents include the study protocol, statistical analysis plan, and informed consent form. All shared data will be de-identified to protect participant privacy and confidentiality. Researchers accessing the data will be required to provide a methodologically sound proposal and sign a data access agreement that includes a commitment to using the data only for research purposes and not attempting to identify individual participants.

Publications

  • Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

    PubMed 30207593

  • Kim HH, Han SU, Kim MC, Hyung WJ, Kim W, Lee HJ, Ryu SW, Cho GS, Song KY, Ryu SY. Long-term results of laparoscopic gastrectomy for gastric cancer: a large-scale case-control and case-matched Korean multicenter study. J Clin Oncol. 2014 Mar 1;32(7):627-33. doi: 10.1200/JCO.2013.48.8551. Epub 2014 Jan 27.

    PubMed 24470012

  • Hyung WJ, Yang HK, Han SU, Lee YJ, Park JM, Kim JJ, Kwon OK, Kong SH, Kim HI, Lee HJ, Kim W, Ryu SW, Jin SH, Oh SJ, Ryu KW, Kim MC, Ahn HS, Park YK, Kim YH, Hwang SH, Kim JW, Cho GS. A feasibility study of laparoscopic total gastrectomy for clinical stage I gastric cancer: a prospective multi-center phase II clinical trial, KLASS 03. Gastric Cancer. 2019 Jan;22(1):214-222. doi: 10.1007/s10120-018-0864-4. Epub 2018 Aug 20.

    PubMed 30128720

  • Ushiku H, Hosoda K, Yamashita K, Katada N, Kikuchi S, Tsuruta H, Watanabe M. A Risk Model for Surgical Site Infection in the Gastric Cancer Surgery Using Data of 790 Patients. Dig Surg. 2015;32(6):472-9. doi: 10.1159/000440703. Epub 2015 Oct 28.

    PubMed 26505458

  • Inokuchi M, Sugita H, Otsuki S, Sato Y, Nakagawa M, Kojima K. Laparoscopic distal gastrectomy reduced surgical site infection as compared with open distal gastrectomy for gastric cancer in a meta-analysis of both randomized controlled and case-controlled studies. Int J Surg. 2015 Mar;15:61-7. doi: 10.1016/j.ijsu.2015.01.030. Epub 2015 Jan 31.

    PubMed 25644544

  • Nichols RL. Preventing surgical site infections: a surgeon's perspective. Emerg Infect Dis. 2001 Mar-Apr;7(2):220-4. doi: 10.3201/eid0702.010214.

    PubMed 11294711

  • Chetter IC, Oswald AV, Fletcher M, Dumville JC, Cullum NA. A survey of patients with surgical wounds healing by secondary intention; an assessment of prevalence, aetiology, duration and management. J Tissue Viability. 2017 May;26(2):103-107. doi: 10.1016/j.jtv.2016.12.004. Epub 2016 Dec 21.

    PubMed 28049612

  • Giaquinto-Cilliers MGC, Nair A, Von Pressentin KB, Coetzee F, Saeed H. A 'game of dressings': Strategies for wound management in primary health care. S Afr Fam Pract (2004). 2022 Feb 28;64(1):e1-e8. doi: 10.4102/safp.v64i1.5462.

    PubMed 35261259

  • Upton D, Solowiej K. The impact of atraumatic vs conventional dressings on pain and stress. J Wound Care. 2012 May;21(5):209-15. doi: 10.12968/jowc.2012.21.5.209.

    PubMed 22584737

  • Heal C, Buettner P, Raasch B, Browning S, Graham D, Bidgood R, Campbell M, Cruikshank R. Can sutures get wet? Prospective randomised controlled trial of wound management in general practice. BMJ. 2006 May 6;332(7549):1053-6. doi: 10.1136/bmj.38800.628704.AE. Epub 2006 Apr 24.

    PubMed 16636023

  • Dumville JC, Gray TA, Walter CJ, Sharp CA, Page T, Macefield R, Blencowe N, Milne TK, Reeves BC, Blazeby J. Dressings for the prevention of surgical site infection. Cochrane Database Syst Rev. 2016 Dec 20;12(12):CD003091. doi: 10.1002/14651858.CD003091.pub4.

    PubMed 27996083

  • Law NW, Ellis H. Exposure of the wound--a safe economy in the NHS. Postgrad Med J. 1987 Jan;63(735):27-8. doi: 10.1136/pgmj.63.735.27. No abstract available.

    PubMed 3671224

  • Furka A, Simko C, Kostyal L, Szabo I, Valikovics A, Fekete G, Tornyi I, Oross E, Revesz J. Treatment Algorithm for Cancerous Wounds: A Systematic Review. Cancers (Basel). 2022 Feb 25;14(5):1203. doi: 10.3390/cancers14051203.

    PubMed 35267512

Questions about this trial

What is this clinical trial studying?

A study testing Non-Dressing of Surgical Wound and Regular Dressing Change of Surgical Wound in people with Gastrointestinal Tumors and Surgical Wound Infection, run by Fudan University at 4 sites in China.

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 6 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: finished, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of composite wound complications within 30 days after surgery (time frame: Within 30 days after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06263205, which also lists 13 linked publications.

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 22 Jun 2026.

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