RecruitingNAINTERVENTIONAL

Subcutaneous Suture Versus no Subcutaneous Suture for Abdominal Wound Closure

This study, called SUTURE, is investigating a common practice in tummy surgery. After an operation, surgeons close the wound. Sometimes, they stitch the layer of fat just under the skin before closing the very top layer. This study wants to find out if doing this helps prevent infections in the wound, which are a common problem after surgery. Wound infections can lead to a longer hospital stay and more treatments. While many surgeons do these stitches, there isn't enough clear evidence that it always helps, especially for everyday tummy operations. This trial hopes to provide a definitive answer by comparing patients who have these extra stitches with those who don't.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital Augsburg

Enrolment target

655

Start

23 Mar 2026

Estimated completion

30 May 2028

Surgical Site Infection (SSI)Wound Healing Complication

What is this study about?

When you have an operation on your tummy, getting an infection in the wound is a fairly common issue. These infections can cause the wound to heal slowly, lead to more pain, and mean you have to stay in hospital longer or need extra care once you go home. Avoiding these infections is a really important goal for doctors and for your recovery.

After a tummy operation, once the main part of the surgery is done, the surgeon carefully closes up the layers of tissue. One of these layers is the 'subcutaneous tissue', which is the layer of fat just beneath your skin. Some surgeons choose to put stitches in this fatty layer before they close the very top layer of skin. This is a common practice, especially if there's a thicker layer of fat.

The SUTURE study is designed to answer a very important question: does stitching this fatty layer actually help prevent wound infections after tummy surgery? While many doctors do this, especially in operations like Caesarean sections, there isn't enough strong proof for other types of tummy operations. This study will involve patients having elective (planned) tummy surgery and will look at whether those who have these extra stitches get fewer infections compared to those who don't. The aim is to help doctors understand the best way to close wounds to give patients the best chance of a quick and healthy recovery.

Key takeaways

The SUTURE study wants to know if placing stitches in the fatty layer under the skin helps prevent wound infections.
Wound infections are a common problem after tummy surgery.
You'll either have these stitches or not, decided randomly during your operation.
The study focuses on adults having planned tummy operations with a cut of at least 6cm.
You'll be checked for wound infections for 30 days after surgery.
This research aims to find the best way to close abdominal wounds for better patient recovery.

Who may be eligible?

To take part in this study, you need to be an adult, aged 18 or older. You must be having a planned (not emergency) operation on your tummy. This includes operations where the cut is made directly, or operations done with small cuts where a larger cut (at least 6cm long) is still needed to remove something from inside.

There are also some reasons why you might not be able to join. For example, if your surgery is an emergency, if doctors think you wouldn't be able to follow the study instructions or attend follow-up appointments, or if your wound can't be closed right after the surgery, you wouldn't be able to participate. Also, if you're unable to give your informed consent (meaning you can't understand and agree to take part), you wouldn't be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you having a planned (not emergency) operation on your tummy?
Will your tummy incision be at least 6cm long (even if it's keyhole surgery)?
Are you able to follow instructions and attend appointments for about a month after your surgery?

Answer every question to see your result.

What does participation involve?

If you decide to join the SUTURE study, you'll be part of a group of patients who help us learn more about surgery. What happens to you will depend on a simple coin-flip decision made during your operation, after the main surgery, but before your skin is closed. You will either have stitches placed in the fatty layer under your skin, or you won't. You and the doctors checking on you afterwards won't know which group you were in, to make sure the results are fair.

The main thing the study will check is for any wound infections in the 30 days after your surgery. This will involve regular checks of your wound, usually as part of your standard follow-up after surgery. These checks will be done by people who don't know whether you had the extra stitches or not. The total duration of your participation will be about 30 days after your operation.

Potential risks and benefits

Participating in this study might offer a potential benefit of helping future patients by improving our understanding of the best surgical techniques. For you personally, there is no guarantee of direct benefit; you will receive the standard care, and your doctors will ensure your safety throughout. As with any medical procedure, there are always some risks involved, but participating in this study does not add significant new risks beyond those normally associated with your planned surgery. You are also reminded that you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

University Hospital Augsburg
Verified postcode
Augsburg, Germany· Recruiting

Common questions

What is 'subcutaneous suture'?

It's a stitch placed in the layer of fat just under your skin during surgery, before the very top layer of skin is closed.

Why is this study important for me?

It's important because it aims to find the best way to close tummy wounds to reduce the risk of infections, which could lead to better recovery for future patients.

Will I know if I received the stitches?

No, both you and the doctors checking your wound after surgery won't know if the stitches were used. This helps make the study results fair.

How to find out more

Florian Schepp, Dr. med.

florian.schepp@uk-augsburg.de +490821400168803 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.