Three Sutures With Different Absorption Rates for Lower Abdominal Incision

NCT05787171 | Unknown

• 1 other identifier: XJTU1AF2021CRF-019
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The previous studies have demonstrated that wedge excision combined modified buried vertical mattress suture (WE-MBVMS) provides better aesthetic outcomes than traditional ways. Prolonged tension reduction is crucial in WE-MBVMS suppressing scar, while suture used during WE-MBVMS decided the length of tension reducing time to a certain degree. However, presently surgeons select suture for WE-MBVMS mostly according to their personal preference and clinical experience and clinical comparative evidence exposing the best suture for desired cosmetic outcome is lacking. Here, investigators purposed to establish a feasibility trial comparing the scars left by WE-MBVMS using sutures with different tension holding time. This is a feasibility, single-center RCT with 35 patients aiming to compare the scar of the hypogastric incision sutured by three different-absorption-rate sutures with WE-MBVMS. The incision induced by donating skin grafts is evenly divided into three segments, each segment randomly uses one of three different sutures randomly allocated by the SAS (V.9.4) statistical software. The feasibility of this study will be assessed by the primary outcomes, including patient and clinician enrolment refusal as well as their reasons, reasons for ineligibility, recruitment ratio, retention and withdrawal at each follow-up point (1, 3, and 6 months), reasons for withdrawal, integrity of collected data and adverse event rates. Secondary outcome measures of the cosmetic outcome of scar will help shape future fully powered RCT by formulating the sample size.

Conditions

Cicatrix

Outcome Measures

Primary Outcomes (9)

• Visual Analogue Scale (VAS)

  As a 10cm line with 0 presenting the worst and 10 presenting the best overall satisfaction, the score of VAS is collected by patients placing a vertical mark on the VAS.

  1 month after the surgery

• Visual Analogue Scale (VAS)

  As a 10cm line with 0 presenting the worst and 10 presenting the best overall satisfaction, the score of VAS is collected by patients placing a vertical mark on the VAS.

  3 month after the surgery

• Visual Analogue Scale (VAS)

  As a 10cm line with 0 presenting the worst and 10 presenting the best overall satisfaction, the score of VAS is collected by patients placing a vertical mark on the VAS.

  6 month after the surgery

• Patient Scar Assessment Scale (PSAS)

  Six domains including pain, itching, colour, pliability, thickness and relief, are contained in the PSAS.

  1 month after the surgery

• Patient Scar Assessment Scale (PSAS)

  Six domains including pain, itching, colour, pliability, thickness and relief, are contained in the PSAS.

  3 month after the surgery

• Patient Scar Assessment Scale (PSAS)

  Six domains including pain, itching, colour, pliability, thickness and relief, are contained in the PSAS.

  6 month after the surgery

• Observer Scar Assessment Scale (OSAS)

  Six domains including pain, itching, colour, pliability, thickness and relief, are contained in the OSAS.

  1 month after the surgery

• Observer Scar Assessment Scale (OSAS)

  Six domains including pain, itching, colour, pliability, thickness and relief, are contained in the OSAS.

  3 month after the surgery

• Observer Scar Assessment Scale (OSAS)

  Six domains including pain, itching, colour, pliability, thickness and relief, are contained in the OSAS.

  6 month after the surgery

Study Arms (3)

PDS group

EXPERIMENTAL

The skin around the incision is dissociated from the bottom, followed by measuring the length of the wound and dividing it into three segments evenly. Each segment randomly received 2-0 Vicryl suture, 2-0 PDS suture, or 2-0 Ethibond suture to sew up the incision with WE-MBVMS. This is the group which received 2-0 PDS suture to sew up the incision.

Device: WE-MBVMS using suture PDS (polydioxanone; Johnson & Johnson International, USA)

Vicryl group

EXPERIMENTAL

The skin around the incision is dissociated from the bottom, followed by measuring the length of the wound and dividing it into three segments evenly. Each segment randomly received 2-0 Vicryl suture, 2-0 PDS suture, or 2-0 Ethibond suture to sew up the incision with WE-MBVMS.This is the group which received 2-0 Vicryl suture to sew up the incision.

Device: WE-MBVMS using suture Vicryl (Polyglactin 910; Johnson & Johnson International, USA);

Ethibond group

EXPERIMENTAL

The skin around the incision is dissociated from the bottom, followed by measuring the length of the wound and dividing it into three segments evenly. Each segment randomly received 2-0 Vicryl suture, 2-0 PDS suture, or 2-0 Ethibond suture to sew up the incision with WE-MBVMS.This is the group which received 2-0 Ethibond suture to sew up the incision.

Device: WE-MBVMS using suture Ethibond (polyester; Johnson & Johnson International, USA）

Interventions

WE-MBVMS using suture Vicryl (Polyglactin 910; Johnson & Johnson International, USA); DEVICE

The skin around the incision is dissociated from the bottom, followed by measuring the length of the wound and dividing it into three segments evenly. Each segment randomly received 2-0 Vicryl suture, 2-0 PDS suture, or 2-0 Ethibond suture to sew up the incision with WE-MBVMS.

Vicryl group

WE-MBVMS using suture PDS (polydioxanone; Johnson & Johnson International, USA) DEVICE

The skin around the incision is dissociated from the bottom, followed by measuring the length of the wound and dividing it into three segments evenly. Each segment randomly received 2-0 Vicryl suture, 2-0 PDS suture, or 2-0 Ethibond suture to sew up the incision with WE-MBVMS.

PDS group

WE-MBVMS using suture Ethibond (polyester; Johnson & Johnson International, USA） DEVICE

The skin around the incision is dissociated from the bottom, followed by measuring the length of the wound and dividing it into three segments evenly. Each segment randomly received 2-0 Vicryl suture, 2-0 PDS suture, or 2-0 Ethibond suture to sew up the incision with WE-MBVMS.

Ethibond group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• surgical incisions need to be closed after skin gotten;
• incisions at least 10 cm in length;
• patients aged between18 and 60 years old.

You may not qualify if:

• chronic diseases, like diabetes, chronic kidney disease, malignant neoplasms and severe malnutrition;
• pregnancy;
• inability to return for the follow-up visit;
• unwillingness to provide informed consent;
• inability to read or speak Chinese.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xinxi Zhu

CONTACT

0086-18127051613; zhuxinxi1998@stu.xjtu.edu.cn

Jing Jia

CONTACT

0086-15829647221

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: March 28, 2023
• Study Start: November 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: October 31, 2023
• Last Updated: March 28, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)