Wound Management Following Gl Tumor Surgery: Comparing Outcomes of Dressing Changes Versus Non-Dressing Techniques
NCT ID: NCT06263205
Last Updated: 2025-12-15
Study Results
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Basic Information
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RECRUITING
NA
1138 participants
INTERVENTIONAL
2024-04-01
2029-04-01
Brief Summary
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1. Does non-dressing of postoperative wounds in gastrointestinal tumor surgery provide equivalent or better wound healing compared to traditional dressing techniques?
2. Can non-dressing of postoperative wounds reduce patient pain and healthcare costs? Participants in this study, who are diagnosed with gastrointestinal tumors and undergoing surgery, will be randomly assigned to either the non-dressing group or the dressing group. The non-dressing group will have their surgical wounds left exposed after initial postoperative care, while the dressing group will receive regular wound dressing changes every 48-72 hours. Researchers will compare these two groups to see if there are differences in the rate of wound complications, pain levels, and overall healthcare costs.
This study aims to provide evidence-based recommendations for postoperative wound care in gastrointestinal tumor surgeries, potentially improving patient outcomes and reducing medical expenses.
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Detailed Description
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This study is a prospective, randomized controlled trial primarily aimed at comparing the efficacy of wound healing between non-dressing and dressing methods post-gastrointestinal tumor surgery. The secondary objective is to evaluate the effectiveness of the non-dressing approach in reducing postoperative pain and medical expenses.
Inclusion Criteria and Sample Size:
The study plans to enroll 212 patients aged 75 years or younger, diagnosed pathologically with gastrointestinal tumors and scheduled for curative surgery or open gastrointestinal bypass surgery. Participants must have an ECOG (Eastern Cooperative Oncology Group) performance status score of 0/1 and be capable of understanding and signing the informed consent. Exclusion criteria include inability to complete postoperative follow-up, ineligibility for surgical treatment, concurrent skin diseases, history of abdominal trauma or surgery, other uncontrolled severe diseases, ongoing other cancer treatments, and current use of drugs that may affect wound healing.
Study Methodology:
Participants will be randomly assigned to one of two groups: a non-dressing group (Group A) and a dressing group (Group B). Group A will have dressings removed 48 hours post-surgery and keep the wound exposed unless signs of infection are present. Group B will undergo regular dressing changes every 48 to 72 hours until sutures are removed between the 7th and 14th postoperative days. Both groups will be closely monitored for wound treatment and complications such as fat liquefaction, infection, and wound dehiscence.
Withdrawal/Early Termination Criteria:
Patients may withdraw from the study voluntarily at any time. Researchers can also decide to withdraw a patient if continued treatment is deemed not in the patient's best interest. Reasons for withdrawal include but are not limited to other concurrent diseases, death, relapse, complications, receiving non-study treatments, or patient's request to exit the study.
Follow-up Plan:
The study will conduct stringent follow-ups, including observation and assessment of the surgical wound 30 days post-surgery, recording the frequency of dressing changes, total costs, pain scores, and wound comfort levels. The follow-up endpoints include patient withdrawal, change in treatment modality, disease progression, death, or reaching the study's end date.
Observation and Evaluation during the Trial:
All trial procedures must be preceded by obtaining informed consent approved by an ethical committee. All data collected during the trial will be statistically analyzed following the intention-to-treat principle.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Non-Dressing Group
Participants in this group will receive standard wound disinfection and dressing immediately after gastrointestinal tumor surgery. At 48 hours post-surgery, the dressing will be removed and the wound will be left exposed without any disinfection or reapplication of dressing. This state will be maintained until suture removal at 7-14 days postoperatively. This arm aims to evaluate the outcomes when the surgical wound is kept exposed, in contrast to traditional dressing methods.
Non-Dressing of Surgical Wound
Participants will receive standard wound disinfection and dressing immediately after surgery. Unlike traditional methods, the dressing will be removed at 48 hours post-surgery, and the wound will then be left exposed without disinfection or coverage\*\* until suture removal (7-14 days postoperatively). This method evaluates the effects of wound exposure on healing, pain, and healthcare costs.
Dressing Group
Participants in this group will receive standard postoperative care. Their surgical wounds will be covered with dressings immediately after surgery, and these dressings will be 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.
Regular Dressing Change of Surgical Wound
This intervention involves standard postoperative wound care. After surgery, wounds will be disinfected and covered with dressings. Dressings will be changed every 48 hours (with disinfection and reapplication) until suture removal (7-14 days postoperatively), following traditional wound management practices.
Interventions
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Non-Dressing of Surgical Wound
Participants will receive standard wound disinfection and dressing immediately after surgery. Unlike traditional methods, the dressing will be removed at 48 hours post-surgery, and the wound will then be left exposed without disinfection or coverage\*\* until suture removal (7-14 days postoperatively). This method evaluates the effects of wound exposure on healing, pain, and healthcare costs.
Regular Dressing Change of Surgical Wound
This intervention involves standard postoperative wound care. After surgery, wounds will be disinfected and covered with dressings. Dressings will be changed every 48 hours (with disinfection and reapplication) until suture removal (7-14 days postoperatively), following traditional wound management practices.
Eligibility Criteria
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Inclusion Criteria
2. Scheduled to undergo gastrointestinal surgery for gastrointestinal cancer (pathologically confirmed).
3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
4. Possesses sufficient cognitive ability to understand the study protocol and voluntarily signs a written informed consent form.
Exclusion Criteria
2. Concurrent active skin diseases that may affect wound healing (e.g., psoriasis, chronic eczema, atopic dermatitis) located at or near the surgical incision site.
3. History of major abdominal trauma or prior abdominal surgery resulting in abdominal wall deformity or extensive scarring that may affect incision healing or assessment.
4. 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.
5. Planned or ongoing receipt of any other anticancer treatments (chemotherapy, targeted therapy, biological therapy, radiotherapy) or long-term immunosuppressive therapy during the perioperative period.
6. 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).
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Changzheng Hospital
OTHER
Changhai Hospital
OTHER
Shanghai East Hospital
OTHER
Fudan University
OTHER
Responsible Party
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Dazhi Xu
Professor
Principal Investigators
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Dazhi Xu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Changzheng Hospital, Navy Medical University
Shanghai, Shanghai Municipality, China
Shanghai East Hospital, School of Medicine, Tongji University
Shanghai, Shanghai Municipality, China
Changhai Hospital, Naval Medical University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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Dressing
Identifier Type: -
Identifier Source: org_study_id
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