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PDS vs Polyamide for Midline Abdominal Closure

NCT ID: NCT00514566

Last Updated: 2007-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2006-04-30

Brief Summary

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Within the last decade the customary trend of using non absorbable sutures has changed, with numerous studies and meta-analyses advocating the use of slowly absorbable sutures, claiming comparable wound strength with significantly lower incidence of wound complications. It was the objective of this randomized clinical trial to compare two universally accepted suture materials, the non-absorbable Nylon and the slowly absorbable Polydioxanone for midline abdominal closure in the Indian context.

Detailed Description

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64 patients undergoing midline laparotomy were allocated, using block randomization, to mass closure of the abdominal wall with continuous polyamide (34 patients) or continuous polydioxanone (30 patients).

There was an alarmingly higher incidence of wound dehiscence in the PDS group requiring secondary suturing (Nylon 0; PDS 5). Mid-way through the trial, an interim analysis was performed which revealed an unacceptably high incidence of wound dehiscence in the PDS group. This necessitated a premature curtailment of the study. There was, however, a statistically significantly higher incidence of scar pain in the Nylon group (Nylon 9; PDS 1).

There is a need for a study with larger series, and PDS as a choice of suture for midline wound closure cannot be recommended.

Conditions

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Laparotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Surgical Patient undergoing midline laparotomy closure

Group Type ACTIVE_COMPARATOR

Suture for midline abdominal closure

Intervention Type DEVICE

closure with Polyamide or Polydioxanone

Interventions

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Suture for midline abdominal closure

closure with Polyamide or Polydioxanone

Intervention Type DEVICE

Other Intervention Names

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Ethicon Inc., Loop no. 1, 150 cm suture length

Eligibility Criteria

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Inclusion Criteria

* All patients above 12 years of age undergoing midline abdominal fascial closure using a continuous technique in the Department of Surgery, Christian Medical College and Hospital

Exclusion Criteria

* All patients under 12 years of age
* Gynaecological operations
* Abdominal wall hernia repair
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Christian Medical College and Hospital, Ludhiana, India

OTHER

Sponsor Role lead

Principal Investigators

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Rajeev Kapoor, MS(Gen Surg)

Role: STUDY_CHAIR

Christian Medical College and Hospital, Ludhiana, India

Locations

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Christian Medical College and Hospital

Ludhiana, Punjab, India

Site Status

Countries

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India

Other Identifiers

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ChristianMCLudhiana

Identifier Type: -

Identifier Source: org_study_id